REGULATORY INTELLIGENCE

YEAR-END REPORT - 2023

Health Policy Tracking Service - Issue Briefs
Business of Health
International Healthcare

This Issue Brief was written by Melissa D. Berry, a principal attorney
editor on the Publisher's Staff and a member of the Ohio bar.

12/18/2023
I. AFRICA

GSK Licenses Companies to Make Cheap Copies of HIV Prevention Drug

(Reuters) - British drugmaker GSK has signed deals with three companies allowing them to make inexpensive generic versions of its

long-acting HIV preventive medicine for use in lower-income countries, where the majority of new cases occur. [FN2]

The injected drug cabotegravir was approved by regulators in the United States in late 2021. Last July, GSK announced a program with
the United Nations-backed healthcare organisation, the Medicines Patent Pool, which aims to get poor countries access to new HIV
therapies far earlier than they did for previous HIV medicines.

During the HIV/AIDs epidemic in Africa in the 1990s and early 2000s, in which many millions of people died, treatments used widely in
wealthy countries were unavailable on the continent.

GSK said last year the new program could result in the generic form of its injection being available in lower-income countries beginning
in 2026.

The drugmaker's HIV treatment division, ViiV Healthcare, said in a statement on Wednesday it had issued voluntary licenses - waiving
intellectual property rights - to Aurobindo Pharma, Cipla and Viatris, which will manufacture the generic versions of cabotegravir.

The generics will be supplied in 90 countries, subject to regulatory approvals there, the statement said.

Indian drugmaker Cipla will make the injections in India and has plans to manufacture in South Africa, which is trying to grow its
drugs manufacturing industry to meet the continent's needs and reduce a dependency on imports that was exposed by the COVID-19
pandemic.

Pre-exposure prophylaxis (PrEP) is an effective way for an at-risk HIV-negative person to reduce the risk of infection. But until recently,
PrEP was only available in pill form. GSK's product is the first non-pill option.

Describing the licences as 'welcome' in a statement, Medecins Sans Frontieres (MSF)/Doctors Without Borders said that GSK should
provide more information on the current availability and price of the drug in low- and middle-income countries while waiting for generic
production to begin.

The medical NGO said it had been in negotiations with ViiV for months to get enough supplies of the drug, but was still unable to meet
demand.

'ViiV should be ashamed: it has a lifesaving HIV prevention drug at its fingertips but is failing to ensure there's enough available for
people who need it,' said Dr. Helen Bygrave, chronic disease adviser for MSF's access campaign.

A GSK spokesperson said the company shared MSF's ambition to enable broad access to the drug.

'We are moving at pace to increase capacity... to meet the demand,' the spokeperson said, adding that it planned to update partners
including MSF 'in the coming weeks' to share its progress.

Gambia Hires US Law Firm to Consider Action on Toxic Indian Cough Syrup, Minister Says

 
  

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(Reuters) - Gambia has hired a U.S. law firm to explore legal action after a government-backed investigation found that contaminated
medicines from India were 'very likely' to have caused the deaths of children last year, the justice minister told Reuters. [FN3]
At least 70 children in Gambia, most under 5 years old, died from acute kidney injury between June and October.

Local doctors suspected cough syrups imported from India were the likely culprit, Reuters reported earlier this year, and tests by the
World Health Organization (WHO) confirmed the presence of lethal toxins, sparking a global hunt for contaminated medicines.

Gambian Justice Minister Dawda Jallow told Reuters legal action was one option under consideration by the government, the first sign
of potential international litigation over the deaths. Jallow did not say who would be the target of potential legal proceedings or name the
law firm hired to help.

The medicines linked to the children's deaths were made by Indian drug maker Maiden Pharmaceuticals, which denied wrongdoing.
Tests by the WHO found that the Maiden cough syrups contained the lethal toxins diethylene glycol (DEG) and ethylene glycol (EG),
used in car brake fluid. India's government has said its own tests on the drugs found no toxins.

India's health ministry and Maiden did not respond to requests for comment on Gambia's possible legal action. The WHO declined to
comment.

Indian officials have said the WHO failed to prove a causal link to the Gambia deaths, accusing the agency of denigrating its $41 billion
pharmaceutical industry. However, cough syrups made by a second Indian drugmaker have been linked to the deaths of 19 children in
Uzbekistan. India has since made drug testing mandatory for cough syrups before export.

CAUSALITY REPORT

Gambia's justice ministry is considering its options after completion of a new government-commissioned causality assessment by a
panel of international experts, Jallow said.

Reuters has seen a copy of the report, which was presented to President Adama Barrow in April but has not been made public.

In it, experts said they analysed 56 of the cases of acute kidney injury. Of those, they found 22 were 'very likely' to have died from DEG
or EG poisoning after taking Maiden products.

The panel could not confirm the cause of death in another 30 cases but said it was 'highly suggestive' they were killed by DEG and EG.
It said there was not enough evidence in four other cases.

Doctors were able to carry out autopsies on just two of the patients. The pathology from both was consistent with DEG and EG
poisoning, the report said. Of all the medicines tested after the deaths, only Maiden's were shown to be toxic, it said.

DEG and EG can be used by unscrupulous actors as a cheap substitute for propylene glycol, a key ingredient in syrupy medicines,
according to several pharmaceutical manufacturing experts.

Reuters could not determine if Indian authorities had seen the causality report.

It is the latest piece of a months-long investigation into the deaths, which raised concerns among global health officials about lax
regulation in India's drug sector and oversight of pharmaceutical raw materials worldwide. Many of the countries India supplies,
including Gambia, have no means of testing imported drugs.

The WHO has said it is continuing to investigate the source of contaminated cough syrups in Gambia, Uzbekistan and several other
countries, but has been frustrated by a lack of information regarding Maiden's drugs. A key middleman in the supply chain of those
medicines is still unknown, Reuters found.

Gambia's Minister Dawda said the causality assessment and the justice ministry's recommendations would be made public within six
months.

Gambia is planning to build a testing facility for imported drugs with support from the World Bank, the bank told Reuters.
Il. AMERICAS

Doctor Accused of Spreading Deadly Meningitis Arrested in Mexico

(Reuters) - Mexican police detained a medical doctor accused of using infected medicines that may have caused a mysterious
meningitis outbreak in northern Durango state, after the disease killed at least 35 women in recent months. [FN4]
Another 79 people have been hospitalized with signs of infection.

Police arrested the doctor who specializes in anesthesiology early on Tuesday morning on charges of illegal practices including the re-
use of medications at the private hospitals where he worked. The doctor's full name was not disclosed.

Meningitis is typically associated with painful inflammation of the brain and spinal cord, often caused by a virus or in some cases
bacteria or a fungal infection.

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The affected patients in Durango were likely infected by fungal meningitis while having procedures in the same hospitals where the
doctor worked, according to Durango state prosecutor Sonia Garza.

She told reporters at a news conference on Tuesday in the state capitol that the first procedures associated with the infected patients
took place last August, and that many of them had been administered anesthesia for obstetric procedures.

'This specialist carried out procedures with no restraint,' said Garza, adding that he brought his own medication for patients, including
unauthorized controlled drugs.

The outbreak has raised concern in both Mexico and from international bodies after the outbreak's first death was confirmed last
November.

Garza added that the detained doctor was the only physician who conducted procedures at the four hospitals where the infections have
been observed. She said that he denied using his own medications at a hearing before prosecutors.

Reuters was not immediately able to request comment from the doctor, or locate his lawyer, but his son, contacted by Reuters,
proclaimed his father innocence.

"They accused my father without any evidence,' he said, declining to provide his name.

The meningitis outbreak is confined to private hospitals in the state capital, also known as Durango, according to Mexico's health
ministry.

Novavax to Receive $350 million from Canada for Unused COVID Shots
(Reuters) - Novavax Inc said on Friday Canada will pay $349.6 million to settle the forfeiting of certain doses of its COVID-19 vaccine
previously scheduled for delivery. [FNS]

The U.S. vaccine maker also reached a deal with the country's public works and government services department to amend the
advance purchase contract after a sharp decline in global demand left a raft of COVID-19 doses unused.

The number of vaccine doses due for delivery has been reduced and the schedule for remaining doses to be shipped revised under the
amended terms, the company said.

The payment will be made in two equal installments in 2023 and the original value of the contract remains unchanged.

However, the department can terminate the contract if the company fails to achieve regulatory approval for vaccine production at the
Biologics Manufacturing Centre by Dec. 31, 2024.

Novovax - which has its COVID-19 vaccine as the only marketed product after 35 years in business - has raised doubts about its ability
to remain in business, flagging uncertainties around its revenue and funding crunch.

The company said in May it expects 2023 revenue between $1.4 billion and $1.6 billion, of which $800 million was from 'locked-in'
overseas purchase contracts for the COVID shot that it has committed to ship this year.
lil. ASIA

Indonesia Court Hears Class Action Suit After Children Die from Tainted Cough Syrup
(Reuters) - Families of Indonesian children who died because of tainted cough syrup demanded restitution as an Indonesian court on
Tuesday started hearing their class-action lawsuit against government agencies and pharmaceutical firms. [FN6]

About 200 children have died of acute kidney injury in Indonesia since last year and authorities have said two ingredients, ethylene
glycol and diethyelene glycol, found in some syrup-based paracetamol medications are linked to the iliness.

The two ingredients are used in antifreeze, brake fluids and other industrial applications, but also as a cheaper alternative in some
pharmaceutical products to glycerine, a solvent or thickening agent in many cough syrups. They can be toxic and can lead to acute
kidney injury.

Twenty-five families are suing the health and finance ministries, the drugs regulator and at least eight drug companies. Awan Puryadi,
the families' lawyer, told Reuters they each wanted compensation of up to 3.4 billion rupiah ($224,570.67).

Solihah, 36, who was at the court in the Indonesian capital Jakarta, said her 3-year-old daughter was diagnosed with the acute kidney
injury after consuming a syrup medication and died a few days later. She said she wanted the government to be held accountable.

'If my daughter had not consumed the drug, maybe she would still be here,' she said, her voice breaking with emotion. 'I hope all parties
involved are held responsible for the conditions of the children who died and are still sick.'

Representatives of the finance ministry and five pharmaceutical companies named in the suit did not respond to requests for comment.
Another three companies could not be reached.

The country's drugs regulator, BPOM, said it would respect the ongoing legal process, while the health ministry declined to comment.

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Authorities have banned several cough syrups and mounted legal action against several pharmaceutical companies whose products
allegedly contained the dangerous ingredients.

India Cracks Down on Pharma Firm Marion Linked to Uzbekistan Deaths
(Reuters) - Indian police on Friday arrested three employees of a pharmaceutical firm whose cough syrups were linked to the deaths of
19 children in Uzbekistan, a police officer said, as the country looks to recover from recent setbacks to the industry. [FN7]

The arrests were made after tests by an Indian government laboratory found 22 drug samples of Marion Biotech Pvt Ltd, based near
New Delhi, 'adulterated and spurious,' according to a police document seen by Reuters.

Police said they arrested Marion's head of operations and two chemists on the basis of a complaint received by an inspector of the
Central Drugs Standard Control Organisation (CDSCO), which investigated the company three times in December and once in January.

'The adulterated and spurious drugs can cause grievous hurt to the public and it is suspected that related material/records may be
disposed of,' CDSCO drug inspector Asheesh Kaundal said in his complaint.

Two Marion directors were 'out of the country and will be arrested as soon as they land in India,' senior police official Ram Badan Singh
told Reuters.

The company did not answer calls from Reuters and did not immediately respond to an email seeking comment.

Uzbekistan in December said the children died after consuming Marion's cough syrups. India suspended Marion's production soon
after.

Analysis by Uzbekistan's health ministry showed the syrups, Ambronol and DOK-1 Max, contained a toxin, ethylene glycol. The syrups
were administered in doses higher than the standard for children, either by their parents, who mistook it for an anti-cold remedy, or on
the advice of pharmacists, according to the analysis.

The same toxin was found in cough syrups exported to Gambia by another Indian company, Maiden Pharmacedticals.

India in October suspended production at Maiden for violations of manufacturing standards after the World Health Organization said
four of its cough syrups may have killed dozens of children in Gambia.

The company has denied that its drugs were at fault for the deaths in Gambia and tests by an Indian government laboratory found there
were no toxins in them.

An Indian court last month sentenced two Maiden executives to two and a half years in jail for exporting shoddy drugs to Vietnam a
decade ago.

The deaths in Gambia and Uzbekistan have dented the image of the $41 billion pharmaceutical industry in India, which is known as the
'pharmacy of the world.'

Indonesia Police Probe Drug Regulators Over Cough Syrup

(Reuters) - Indonesia's police are conducting preliminary inquiries into whether any actions by officials at the country's drug regulator
could amount to criminal wrongdoing, as they expand a probe into tainted cough syrups linked to the deaths of more than 200 children

across the nation, two top inspectors told Reuters. [(FNE]

The police scrutiny of Indonesia's food and drugs agency (BPOM) is the latest escalation by states seeking accountability for
contaminated syrups that were linked to the deaths of dozens more children in Gambia and Uzbekistan last year. The World Health
Organization is working with countries to investigate the global pharmaceutical supply chain for such syrups.

Late last year police arrested and charged eight individuals at Indonesian companies that imported and distributed raw materials to
drugmakers whose cough syrups were found to contain toxic industrial-grade chemicals instead of the legitimate ingredient.

Andika Urrasyidin, lead police investigator of the case, told Reuters police have called in 'many' BPOM officials for questioning, and the
investigation is still underway.

'We're still looking into it. But ... if there were actions, then yes there needs to be responsibility,' he said, declining to say what, if any,
charges may be brought.

No one at BPOM has been accused of wrongdoing. The police could ultimately pursue criminal charges or close the probe without
taking action.

Officials from the BPOM did not respond to a request for comment.

Hersadwi Rusdiyono, the director of Indonesia's national police's crimes detection unit, said BPOM officials were brought in as
witnesses, but investigators are now checking if any wrongdoing was committed by drug regulators.

'We asked them according to their functions, as regulators, whether they've conducted supervision and what kind of supervision,' he
told Reuters. 'They were only interrogated as witnesses, we're coordinating with the prosecutors.'

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Hersadwi said the probe so far has focused on staff at lower levels and not included BPOM'S chief, Penny Lukito. Penny did not
respond to a request for comment.

BPOM has said a spike in cases of acute kidney injury occurred as several parties 'exploited a gap in the safety guarantee system' and
pharmaceutical companies did not sufficiently check the raw ingredients they used.

In January, Pipit Rismanto, a senior police official, told reporters the authorities had found one company sold 'industrial-grade' toxins as
pharmaceutical-grade propylene glycol, a key base of syrupy medicines.

The toxins, ethylene glycol (EG) and diethyelene glycol (DEG), can be used by unscrupulous actors as a substitute for propylene glycol
because they can cost less than half the price, several pharmaceutical experts told Reuters.

Police have charged four companies involved in the case -- drugmaker Afi Farma, which allegedly sold tainted syrups, CV Samudera
Chemical, which according to the police supplied the chemicals, and two of its distributors Tirta Buana Kemindo and Anugrah Perdana
Gemilang.

A lawyer for Afi Farma, which attended its first court hearing on the case on Tuesday, said the company would respect the law.
Tirta Buana Kemindo declined to comment. CV Samudera and Anugerah Perdana Gemilang could not be reached.

BPOM is also named in a separate class action suit launched in January by parents whose children died or are suffering from long-term
complications of the acute kidney injury.

The first day of trial has not been scheduled and a mediation process has just concluded, said the families' lawyer.
Paracetamol Maker Granules India Flags Significant Operations Hit from Cyber Attack

(Reuters) - Granules India on Thursday warned of a significant loss of revenue and profitability due to a cyber security attack that the
pharmaceuticals company faced late last month. [FN9]

Due to significant changes in its IT systems, the IT security incident caused a major disruption in its business operations, the
Paracetamol maker said in an exchange filing.

On May 25, Granules India reported the information security incident, adding that impacted IT assets affected have been isolated.
The company said on Thursday that a ransomware group had claimed responsibility for the incident.

The company said it had managed to restore production to near-normal levels at present, however it flagged backlogs and delays in the
clearance of materials for quality system approvals for dispatching the products.

US Wants Coalition of Nations to Engage China in Curbing Synthetic Drugs
(Reuters) - The U.S. wants other countries to engage China on limiting the flow of synthetic drugs, the State Department's top official on
narcotics said on Thursday, as Washington complains of a lack of co-operation by Beijing in combating their illegal trade. [FN10]

On the eve of a U.S.-led conference on the issue, the official, Todd Robinson, said China needed to do more to disrupt illicit supply
chains, but it was still unclear if it would join the meeting.

'We've invited China,' Robinson, the assistant secretary of state for international narcotics and law enforcement, told reporters on a
telephone call.

'We don't have any indication at the moment that they're going to participate.'
Although Beijing 'had not engaged' with U.S. officials on the issue in recent months, Washington still actively sought its help, he added.

U.S. Secretary of State Antony Blinken will host on Friday the first virtual meeting of at least 84 countries to set up a 'global coalition' to
combat synthetic drugs.

The gathering is part of a Biden administration policy to curb the highly addictive painkiller fentanyl that has fueled the country's opioid
crisis.

This isn't about blame, and this isn't about pressure,' Robinson said.

'Part of the reason we're trying to bring this coalition together is to engage other countries in their efforts against the supply chain, and
part of their responsibility is going to be engaging with the People's Republic of China (PRC),' he said, using the formal name of the
country.

China is a major producer of the chemicals required to make fentanyl, which is frequently smuggled over the U.S.-Mexico border.

Amid a deterioration in ties between the rivals, China has not been helpful in cracking down on the flow of fentanyl precursor chemicals
or on money laundering related to trafficking, U.S. officials say.

A spokesperson for the Chinese embassy said it was willing to work with other nations.

'China is ready to work with other countries, including the United States, to establish co-operative relations featuring equality, mutual
respect and trust, and win-win cooperation,' the spokesperson, Liu Pengyu, said in a statement.

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'We are willing to carry out counter-narcotics co-operation to share experience in drug control and jointly tackle the drug problems.'

Beijing has said Washington should stop using the fentanyl crisis as a pretext to impose sanctions on Chinese companies, and state
media have repeatedly said addiction and demand for the drug are U.S. domestic problems.

'We hope the U.S. side will take concrete action to address China's concerns and create conditions for more bilateral and multilateral
cooperation on drug control,' Liu added.

Almost 80,000 Americans died from opioid-related overdoses in 2022, the Centers for Disease Control says.

The U.S. Justice Department filed criminal charges in June against four Chinese chemical manufacturing companies and eight people
over accusations that they illegally trafficked the chemicals used to make fentanyl.

Biocon May List Biosimilars Business by 2025 First Half - CEO
(Reuters) - Indian biopharmaceutical company Biocon Ltd is planning to list its biosimilars business, a significant contributor to the
company's total revenue, by the first half of 2025, a top executive said on Friday. (FN11]

Biocon Biologics, a fully integrated subsidiary of Biocon Ltd, focuses on making biosimilars, with key revenue-generating markets being
the United States and Europe.

'l would say it (listing of the biologics business) can happen any time after the second half of 2024 ... it is likely to happen in the first half
of 2025,' Biocon Ltd CEO and Managing Director Siddharth Mittal told Reuters.

Last year, Biocon acquired U.S.-based Viatris Inc's biosimilar business.

There are a couple of milestones (to meet) before we get to that stage ... we have to complete transition of all territories of Viatris to us
and we are looking at reducing the debt which was taken to fund the acquisition,' Mittal said.

Biosimilars are copies of costlier complex biological drugs used to treat ilinesses such as cancer, rheumatoid arthritis and psoriasis.

According to research and analytics services firm IQVIA, the global biosimilar market value is expected to grow to an estimated $75
billion by 2030 from $17.9 billion in 2020.

McKinsey also estimates the industry to see continued double-digit growth to become a $60-billion market by the decade's end.

On Thursday, Biocon reported a 29.8% drop in first-quarter profit. Revenue, however, jumped 60%, helped by the strong performance
of the biosimilar business.

Revenue growth in the biosimilars business more than doubled during the quarter to 20.15 billion Indian rupees. read more
Biocon Biologics has a portfolio of more than 20 products primarily focusing on oncology, immunology and diabetes.
India's Torrent Pharma in Talks with CVC, Bain Capital for Cipla Bid - Sources

(Reuters) - India's Torrent Pharmaceuticals is in talks with private equity funds CVC Capital Partners and Bain Capital to raise up to
$1.5 billion to bid for India's Cipla, according to three sources with direct knowledge of the matter. (FN12]

Torrent and Blackstone are among those interested to acquire a stake in Cipla, India's third-biggest drugmaker by sales, in what could
be the largest pharma deal in India ever.

Cipla's founding family is keen to sell their 33.4% holding entirely, sources say, and any bid will also trigger an open offer for another
26% stake, as per Indian regulations. That translates to a $6.75 - $7 billion deal, Bernstein estimated in an Aug. 30 report.

Torrent is likely to reach a decision to finalize its consortium financing partner in the next few days, said the first source.

Bain and Blackstone declined to comment while Cipla, Torrent and CVC did not respond to comments. The Economic Times first
reported CVC's talks with Torrent on Monday.

Cipla also exports medicines to North America and South Africa, and sells generic drugs to treat illnesses like cold, fever and
headaches. It competes with global majors Pfizer and Abbott, among others, in the world's most populous nation whose pharmaceutical
market is expected to reach $130 billion by 2030, from $50 billion currently.

Torrent, whose market cap is 54% lower than Cipla's $11.9 billion, is present in more than 40 countries and sells medicines related to
diabetes, pain management, gynaecology, oncology and anti-infective segments as per its website.

Torrent and Blackstone both have submitted non-binding bids for Cipla, sources say.

Foreign banks, including Morgan Stanley and Barclays are also in talks with Torrent to arrange potential debt financing for the deal, the
second and third source said.

Barclays declined to comment while Morgan Stanley did not immediately respond.

The second source said Cipla is likely to be more keen on getting a strategic partner on board, like Torrent, instead of a pure financial
investor, though a final decision was not likely soon.

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A Bernstein report in August flagged possible antitrust scrutiny and requirement to divest brands when combined market shares are
high. It added that product overlap between Cipla and Torrent is 'manageable' as there were only four overlaps at the molecule level
where the 'combined sales share would cross the 90% mark.'

Pakistan Probes Distributors of Roche Cancer Drug After Patients Go Blind
(Reuters) - Pakistan said on Monday it was investigating two local distributors of Swiss pharmaceutical company Roche's Avastin
cancer drug after 12 diabetic patients injected with the drug went blind. [FN13]

The Drug Regulatory Authority of Pakistan (DRAP) said the health authorities in Punjab, the most populous province, had launched the
investigation into local use of the drug Avastin, which is licensed for use in Pakistan.

'Incidents of loss of vision in diabetic patients have been reported following treatment with Altered/Dispensed/Diluted Avastin injection,'
the regulator said in a statement.

Javed Akram, the province's Minister for Specialised Health, said police were questioning two men they believe to be the drug's
distributors in the state.

'A high level commiitee has been constituted to probe the issue. A case has been registered against the distributor and his aide,' Akram
said.

Following the incidents, the DRAP instructed the importer to recall the suspected batches of Avastin 100mg injection, which it said had
been created illegally.

"The sale/distribution of registered Avastin injection has been put on halt till verification of its quality through sampling and laboratory
testing to safeguard public health,' it said in a statement on its website.

On its website, Roche said Avastin was approved in more than 130 countries, including the United States, to treat several types of
cancer.

'Roche strongly condemns this criminal act of counterfeiting and is doing everything in its power to cooperate with the authorities to
protect patients from counterfeits,' said Roche in a statement to Reuters.

'In Pakistan, the vision loss from Avastin has been identified by the authorities as a case of contamination by a third party supplier,' it
added.

The regulator said in its statement that in the cases concerned Avastin had been used off-label, meaning outside its approved use, to
treat diabetes-related eye conditions.

Cancer drug Avastin, when used at much lower doses, is similar to eye drug Lucentis and is used in many countries as a low-cost
option to treat certain blindness-causing conditions.

In its statement, Roche said: 'Avastin is not approved for any use in the eye. Counterfeit medicines pose a health risk to patients
because their content may be ineffective and contain harmful ingredients.'

Alam Sher, Punjab's deputy drug controller who filed the police complaint against the distributors, told Reuters that some companies
buy Avastin and repackage it in smaller doses to make it more affordable for patients.

A sharp drop in the value of the local currency against the U.S. dollar has inflated the price of drugs in Pakistan, many of which are
either imported or based on imported ingredients. Record high inflation has also diminished the purchasing power of many people.

Indonesian Court Jails CEO, Three Others, Over Deadly Cough Syrup

(Reuters) - An Indonesian court sentenced to jail on Wednesday the chief executive and three other officials of a company whose
cough syrup has been linked to the death of more than 200 children, for violating drug safety laws, the company's lawyer said. (FN14]

The Indonesian company, Afi Farma, was accused of producing cough syrups containing excess amounts of toxic material and
prosecutors charged the four officials for 'consciously' not testing the ingredients, despite having the means and responsibility to do so,
according to a charge sheet.

The company's lawyer, Reza Wendra Prayogo, said they denied negligence and the company was considering whether to appeal.

The officials, including CEO Arief Prasetya Harahap, were sentenced to two years in prison by a court in the town of Kediri, in East
Java province, where the company is based.

Prosecutors, who had sought up to nine years in prison for the accused, said that Afi Farma did not test the ingredients sent by its
supplier and instead relied on certificates provided by them regarding product quality and safety.

Reza told Reuters in October that Indonesia's drug regulator, BPOM, did not require drugmakers to do rigorous testing of ingredients.

The case comes as efforts grow worldwide to tighten oversight of drug supply chains after a wave of poisonings linked to contaminated
cough syrups that killed dozens of children in countries such as Gambia and Uzbekistan.

Blackstone Enters Indian Healthcare Services with Care Hospitals Buy

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(Reuters) - Blackstone said on Monday it will buy a majority stake in India's Care Hospitals from a fund belonging to asset management
firm TPG, marking the U.S.-based private equity firm's entry into the country's healthcare services sector. [FN15]

Blackstone will commit $1 billion in the hospital chain in India and hold over 75% in Care Hospitals, a source with direct knowledge of
the matter said. They did not want to be named as the deal details are private.

The deal comes as a post-pandemic boom in demand for private healthcare in India has made the sector attractive, with global
investors seeking an entry into healthcare chains in the country.

'Life sciences is a key investment theme for Blackstone and we plan to bring in our global scale and operating expertise,'' said Ganesh
Mani, managing director at Blackstone Private Equity.

In a separate deal, Care Hospitals will buy a majority stake in KIMSHEALTH, which operates under Kims Healthcare Management, to
form one of India's largest hospital platforms with 23 facilities and more than 4,000 beds across 11 Indian cities.

The value of both the deals is between $1.3 billion and $1.5 billion, the source added. The companies did not disclose financial terms of
the deal.

TPG, which has a stake in Care Hospitals through its Evercare Health Fund, will retain a significant minority stake in the combined
platform, the statement said.

Blackstone and Care did not immediately respond to Reuters' queries seeking financial details.

Hong Kong-based investment firm BPEA EQT, Baring Private Equity Asia, will acquire a 60% stake in Indian fertility services provider
Indira IVF for 54 billion Indian rupees ($648.63 million), Reuters had reported in July, citing a source.

Moderna Begins Work on China mRNA Manufacturing Site
(Reuters) - U.S. vaccine maker Moderna began construction of its first facility in China this month to manufacture mRNA medicines, the
company said on Tuesday. [FN16]

Moderna's COVID-19 vaccine has yet to be approved in China, but the company said in July it had signed a deal with the city
government of China's financial hub Shanghai to work towards opportunities for it to research, develop and manufacture mRNA
medicines in the country.

The facility in Shanghai would manufacture medicines for the domestic population, the world's second largest after India, a
spokesperson for Moderna told Reuters.

'Our focus in China is on strengthening health security by targeting unmet needs and contributing to the ecosystem of medical solutions
available to patients in China,' it said in an emailed statement.

It did not say what it planned to make at the facility and when production might start.
IV. EUROPE

Medical Device Makers Drop Products as EU Law Sows Chaos
(Reuters) - Nicola Osypka's German company has been selling medical devices used in surgery on newborn babies in Europe for
decades, but new European Union rules have forced her to make tough decisions. [FN17]

Under the regulations designed to prevent another health scandal, such as the one in 2010 involving ruptured breast implants made by
Poly Implant Prothese, companies must apply for new certificates for their medical equipment.

But Osypka says the small firm founded in 1977 by her father Peter cannot afford the process and it has withdrawn five lines of devices
sold in the EU, some for more than 30 years.

'A law created to stop one criminal company's actions 10 years ago now endangers patients' lives, including children, and European
manufacturing sites,' said Osypka.

'ls that what the EU wants for its citizens?'

Osypka AG is one of eight companies Reuters has spoken to, including Swedish medical equipment maker Getinge, that are
withdrawing devices from the EU market, or have stopped making them due to the cost it takes to comply with the rules.

While some companies say the products they have cut have no impact on patients or profits, others say some of withdrawn devices are
essential, and doctors agree.

Under the EU's Medical Devices Regulation (MDRY), which came into effect in May 2021, all medical devices, from implants and
prosthetics to blood glucose meters and catheters, must meet stricter safety criteria, sometimes with new clinical trials.

The eight manufacturers all said the requirements were stretching the time it takes to get a certificate for a product line to as much as
two-and-a-half years, compared with a few months under the old system.

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Costs have also surged, by anywhere from three to 10 times, the companies said. As a result, some are simply allowing their product
certifications to lapse, which means hospitals in the EU can no longer use their devices.

The EU Commission, in response to Reuters' questions, said it was concerned about the pace of the implementation of the new rules
and would do all it could to ensure patients have access to the medical devices they need.

DISRUPTION FOR DOCTORS

Reuters also spoke to two medical associations, three doctors and two regulatory experts and, like the companies, they said the new
rules were causing widespread disruption and shortages of crucial equipment.

The doctors, in Austria, Belgium and Germany, said in some cases they were unable to provide their standard quality of care because
devices for routine procedures were no longer available.

The Standing Committee of European Doctors (CPME), a group of national medical associations, told Reuters that hospitals in Austria
and Denmark have reported shortages of critical devices.

France's national medical regulator (ANSM) told Reuters that the country's health system was being affected by shortages of various
types of devices, partly because of the new law.

Nicola Osypka, a molecular biologist, said she sat down with staff to run the numbers on their niche products, such as a miniscule
catheter used to keep newborns with non-functioning heart valves alive until surgery can be performed.

"These types of products are totally beneficial for these patients, but we cannot afford the half a million euros it takes to conduct a
clinical study, even though these products have been on the market for 30 or 40 years,' she said.

Just as painful is the fact Osypka cannot afford costs estimated at one million euros ($1.1 million) to prepare the application for an
innovative product that has already been through clinical trials.

The company's new stent for babies was developed over eight years and doctors successfully used it on 19 babies during the trial in
Germany, according to the results seen by Reuters.

John O'Dea, chief executive of Palliare, a small Irish medical equipment manufacturer, is so keen to get his firm's new laparoscopic
device for surgery in the abdomen or pelvis onto the market, he has swallowed the costs.

The process has taken a year and a half so far and O'Dea estimates the total cost will come to about 100,000 euros, for equipment
approved two years ago by the U.S. Food and Drug Administration.

Under the old system, it took about 15,000 euros and a few months to get a similar device approved, he said.
SYSTEM OVERLOAD

The costly approval process is the latest blow to the world's second-biggest medical device market, worth more than $150 billion, which
is already reeling from soaring energy bills and unpredictable supply chains following pandemic lockdowns.

An EU Commission spokesperson said in an emailed statement that there were currently not enough agencies, known as notified
bodies, to do the work of recertifying products, though device makers had also not prepared sufficiently for the change.

Brussels has authorised 36 agencies and is considering 20 more applications, the spokesperson said.

Tom Melvin, an associate professor of medical device regulatory affairs at Trinity College Dublin, said there were nearly 100 such
agencies a decade ago under the old system.

In a major concession, the EU Health Commissioner proposed on Dec. 9 to delay the May 2024 deadline for companies to comply with
the new law to 2028 to prevent shortages.

The extension will require an amendment to the law to be approved by the European Council and Parliament, which would not happen
until next year.

While a delay would mean some devices will not be cut in the short term, it would not address the logjams and high costs putting firms
off going through the process, executives such as Frank Matzek, vice president of regulatory and governmental affairs at Biotronik, a
cardiac devices maker in Berlin, said.

EU Commission data released this month shows the scale of the problem.

Under the old system, there are about 25,000 certificates. So far, manufacturers have submitted applications under the new system for
about 8,000, but less than 2,000 have been approved.

Certificates cover multiple devices, and in some cases whole product lines, making it hard to estimate the number of products
potentially affected. Industry experts say about 500,000 different devices are sold in the EU.

GOING BACKWARDS

Even large companies with deeper pockets and more experience of handling tough global regulations say they have been astonished
by the new system's complexity and expense.

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Getinge, which makes products for surgery, intensive care and sterilization, has new certificates for about 20% of its portfolio and feels
it is on track to meet the deadline, said Mikael Johansson, an executive overseeing MDR implementation.

But that work started in 2018, required a full review of the company's portfolio and resulted in the removal of about a third of Getinge's
products from its range of hundreds of devices.

He said the cull was 'healthy' in that it removed products with little effect on profit, but recertification of the rest has been more
demanding and taken much longer than expected.

But as some companies press ahead, others are letting certifications lapse.

Andreas Kohl, who runs stent and catheter manufacturer AndraTec in Germany, said he plans to drop two or three devices because he
cannot afford to apply for all six of his products currently sold in the EU.

Balton in Poland told customers in October it would ditch over a dozen products, including catheters and stents used for coronary
angioplasties and pacing electrodes, due to the costs and other difficulties of complying with the new law, according to an email seen
by Reuters.

The company did not respond to requests for comment.

Doctors say the starkest example of the impact of the company decisions has been on devices for rare conditions, such as catheters
used on newborns with heart problems.

Marc Gewillig, director of paediatric cardiology at the University Hospital Leuven, a teaching hospital in Belgium, said he has lost
access to nearly a dozen devices needed for procedures, forcing him to improvise on three babies.

For one procedure, he said he had to use a catheter to access the atrial septum in the heart through the groin, instead of through the
umbilical cord with a balloon catheter.

The procedure is usually carried out within five minutes of birth, but without the preferred device, he must transfer the baby to another
part of the hospital, delaying it by 30 minutes.

"Those are minutes in a child with little oxygen going to its brain,' he said. 'We're going back in medicine by 20 to 30 years.'

AbbVie, Eli Lilly Exit UK Drug Pricing Agreement

(Reuters) - Pharmaceutical companies AbbVie and Eli Lilly have withdrawn from Britain's voluntary medicines pricing agreement, an
industry body said on Monday. [FN18]

Companies are increasingly arguing that it is no longer possible to justify the UK's 'voluntary scheme' to global boardrooms and
investors as repayment rates in 2023 have surged to 26.5% of revenue, the Association of the British Pharmaceutical Industry (ABPI)
said in a statement.

'The current scheme has harmed innovation, with costs spiralling out of control, and the UK falling behind other major countries to be
left as a global outlier,' said Laura Steele, president and general manager for Eli Lilly's Northem Europe division.

ABPI said it was seeking early talks with the government to set out a new future settlement.

In December, the industry body had said the government raised the amount manufacturers of branded medicines within the voluntary
scheme will be required to return to almost 3.3 billion pounds ($4.02 billion) in sales revenue from an earlier amount of 1.8 billion
pounds.

The demand from the UK's National Health Service (NHS) and use of new medicines to treat patients have grown faster than the
industry's pre-pandemic projections, which has driven repayment rates far beyond sustainable levels, ABP| added.

The current voluntary scheme, which will end in December, is an agreement between the British government and the pharmaceutical
industry with roots going back to the foundation of the NHS, ABPI said.

Britain Faces Largest Ever Healthcare Strikes as Pay Disputes Drag On

(Reuters) - Britain faces its largest ever strike by health workers on Monday as tens of thousands of nurses and ambulance workers
walk out in an escalating pay dispute with the government, spelling further disruption for an already strained health system. (FN19]

Nurses and ambulance workers have been striking separately on and off since late last year but Monday's walkout involving both,
largely in England, will represent the biggest in the 75-year history of the National Health Service (NHS).

England's top doctor, Stephen Powis, said strike action this week, which will also see physiotherapists walk out on Thursday, would
most probably be the most disruptive so far.

Health workers are demanding a pay rise that reflects the worst inflation in Britain in four decades, while the government says that
would be unaffordable and cause more price rises, and in tum, make interest rates and mortgage payments go up further.

Around 500,000 workers, many from the public sector, have been staging strikes since last summer, adding to pressure on Prime
Minister Rishi Sunak to resolve the disputes and limit disruption to public services such as railways and schools.

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Asked by Sky News if the strikes would put lives at risk, business minister Grant Shapps said he was "concerned that it does" because
of a lack of cooperation between the back-up services, such as the army, and those workers who are striking.

"The Royal College of Nursing (RCN) have very responsibly ... told the NHS this is where we are going to be striking and they're able to
put the emergency cover in place. Unfortunately, we've been seeing a situation with the ambulance unions where they refuse to provide
that information," he said.

Ambulance workers have denied Shapps' allegation.

Sharon Graham, leader of the Unite union, told the BBC on Sunday she wanted Sunak to come to the negotiating table, accusing the
government of lying about ambulance workers.

"This government is putting lives at risk," she said.

The NHS, historically a source of pride for most Britons, is under extreme pressure with millions of patients on waiting lists for
operations and thousands each month failing to receive prompt emergency care.

The RCN says a decade of poor pay has contributed to tens of thousands of nurses leaving the profession - 25,000 over just the last
year - with the severe staffing shortages impacting patient care.

The RCN initially asked for a pay rise of 5% above inflation and has since said it could meet the government "halfway", but both sides
have failed to reach an agreement despite weeks of talks.

Meanwhile, thousands of ambulance workers represented by the GMB and Unite trade unions are also set to strike on Monday in their
own pay dispute. Both unions have announced several more days of industrial action.

Not all ambulance workers will strike at once and emergency calls will be attended to.

In Wales, nurses and some ambulance workers have called off strikes planned for Monday as they review pay offers from the Welsh
government.

Sunak said in a TalkTV interview last week he would "love to give the nurses a massive pay rise" but said the government faced tough
choices and that it was funding the NHS in other areas such as by providing medical equipment and ambulances.

WHO Report on Ukraine Health Emergency Sparks U.S., Russia Row
(Reuters) - The United States and Russia faced off on Saturday over a World Health Organization report on the humanitarian crisis in
Ukraine, with Moscow saying it was politically motivated and Washington calling for it to be swiftly updated. [FN20]

WHO Director General Tedros Adhanom Ghebreyesus's report was presented to the organisation's executive board, on which both
Russia and the United States sit.

It covered events in the first nine months of 2022 and classed the situation in Ukraine, which Russia invaded on Feb. 24, as one of
eight acute global health emergencies.

The report documented more than 14,000 civilian casualties, with 17.7 million people in need of humanitarian assistance and 7.5 million
Ukrainian refugees displaced across Europe.

Of 471 attacks with heavy weapons on healthcare facilities globally, 448 occurred in Ukraine, the WHO report said.

Russia's representative to the WHO board called it politicised and one-sided and described its references to Ukraine as unfounded
accusations.

Moscow has denied targeting civilians in Ukraine since it began what it calls a special military operation, which has also devastated
Ukraine's cities, killed thousands of combatants and shaken the global economy.

Sheba Crocker, U.S. representative to the United Nations, called for an updated report to document incidents in Ukraine since
September.

'Russia's attacks ... have caused unspeakable harm to civilians and critical infrastructure in Ukraine,' she told the board meeting,
according to a statement from her office.

'...This senseless death and destruction falls brutally on children, the elderly, and other vulnerable groups' access to vital health care,'
Crocker added.

Finland to Allow Gender Reassignment Without Sterilisation
(Reuters) - Finland will allow transgender people to change their legal gender at their own request and without undergoing sterilisation,
new legislation signed by the Finnish President confirmed on Friday. (FN21]

The European Court of Human Rights ruled in 2017 that requiring sterilisation in order for individuals to change the sex on their birth
certificate is a violation of human rights.

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Finland's new law will enable people above the age of 18 to legally determine their gender through a self-declaration form, and is meant
to reinforce the protection of the right to self-determination and to reduce discrimination, the ministry of social affairs and health said.

Medical examinations and sterilization will no longer be required to legally change one's gender, it added.
On Friday, Finnish President Sauli Niinisto ratified the new legislation which is will enter into force on April 3.

The Czech Republic, Latvia, and Romania currently require individuals to undergo sterilization before legally changing their gender,
according to Transgender Europe (TGEU).

Dutch to Widen 'Right-to-Die' to Include Terminally Il Children

(Reuters) - The Netherlands will widen its existing euthanasia regulations to include the possibility of doctor-assisted death for
terminally ill children between one and twelve years old, the Dutch government said on Friday. [FN22)

The new rules would apply to an estimated group of around 5 to 10 children per year, who suffer unbearably from their disease, have
no hope of improvement and for whom palliative care cannot bring relief, the government said.

"The end of life for this group is the only reasonable alternative to the child's unbearable and hopeless suffering,' it said in a statement.

In 2002, the Netherlands was the first country in the world to legalise euthanasia under strict conditions. All cases of euthanasia must
be reported to medical review boards.

The law already provided possibilities for euthanasia involving terminally ill babies until their first birthday and for children aged older
than 12.

In 2022, only one instance of euthanasia for a minor between 12 and 16 years old was reported, figures from regional euthanasia
review boards show.

The Netherlands would not be the first to allow doctor-assisted death for children of all ages. Belgium has allowed it since 2014.
Nurses in England Reject Pay Offer, Plan More Strikes

(Reuters) - Nurses in England rejected an offer of a 5% pay rise on Friday and set out plans for further strikes, dealing a blow to Prime
Minister Rishi Sunak's attempts to end the dispute and potentially further straining the country's health service. [FN23]

About 54% of nurses who took part in a ballot voted to reject the deal, said the Royal College of Nursing (RCN) trade union, which had
recommended they accept. Turnout was 61% of eligible members.

The RCN said its members would stage a 48-hour strike from April 30, which for the first time will be joined by nursing staff from
emergency departments, intensive care units, cancer care and other services that were previously exempt.

The result represents a major setback for Sunak's government, which has been embroiled in pay disputes with hundreds of thousands
of public workers as wages fail to keep up with double-digit inflation.

Tens of thousands of nurses have taken part an unprecedented wave of strikes since December, disrupting an already strained national
health service that is NHS dealing with record patient backlogs and serious staff shortages.

'Until there is a significantly improved offer, we are forced back to the picket line,' RCN General Secretary Pat Cullen said in a letter to
Health Minister Steve Barclay.

'Meetings alone are not sufficient to prevent strike action and | will require an improved offer as soon as possible.'

Sunak, who took office in October, has made cutting waiting lists for hospital treatment in the NHS one of his priorities, and faces local
elections in May ahead of a national ballot expected next year.

Opinion polls have shown strong support among the British public for striking nurses, who the RCN says have suffered over a decade
of poor pay, contributing to thousands leaving the profession.

The result of the ballot comes after the government and healthcare trade unions agreed on a pay proposal comprising a one-off
payment of 2% of 2022/23 salaries and a 5% pay rise for the 2023/24 year, which began this month.

Most unions including the RCN had recommended their members accept the offer, even though they had generally sought wage hikes
more in line with inflation, which has been near 10% in recent months.

Earlier on Friday Unison, which represents ambulance staff and others health workers, said its members have voted to accept the offer.

'This offer was recommended by the union leaders themselves as being fair and reasonable. They recognised how far the government
moved,' finance minister Jeremy Hunt told Sky News.

'What the public want is an end to these strikes.'

Other high-profile pay disputes in Britain that have caused disruptive strikes - including those involving school teachers and the
government and railway workers and their employers - remain ongoing.

Europe Faces Long Wait for Weight-loss Drugs as Governments Eye Costs

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(Reuters) - Novo Nordisk will start selling its hugely popular obesity drug Wegovy in Germany this month, its third European market, but
only people who pay from their own pocket or have certain private health insurance plans will be able to get it. [FN24]

A decades-old German law bans public health insurance schemes from paying for weight-loss drugs, categorising them alongside pills
for impotency or baldness as a lifestyle choice rather than a health necessity.

That means the cost of Wegovy, which has a U.S. list price of $1,350 a month, will not be reimbursed for the 90% of Germans covered
by such plans. Novo has yet to set a price for Wegovy in Germany, Europe's largest pharma market.

Germany's stance on weight-loss drugs is among the region's strictest, even though the proportion of its citizens who are overweight is
above the European Union average.

It highlights the challenge Novo and rivals face in convincing European governments to pay for obesity drugs, which analysts say is
likely to slow their take-up there.

Some doctors argue that Wegovy could help stem a tide of weight-related conditions such as heart disease or joint pain that are
themselves costly to treat.

Martin Merkel, a medical professor and member of the German Endocrinology Society, said the drug offered a 'very, very good
opportunity' to reduce weight and prevent follow-on disease.

'How many knees would not have to be operated on if we were all slimmer?' said Merkel, adding that pushing diet and exercise alone
has shown limited success.

Other researchers, including dietician and senior lecturer Duane Mellor of Aston University in Birmingham, England, say promoting a
healthier lifestyle should take precedence over prescription drugs.

SLOWER THAN EXPECTED

Production problems and a struggle to keep up with overwhelming U.S. demand have already led to a slower-than-expected roll out of
Wegovy in Europe.

Novo boss Lars Fruergaard Jorgensen said in a newspaper interview on June 24 that the Danish company would launch the drug in
Germany at the end of July.

Germany's health ministry told Reuters there were no plans to change the law to cover weight loss drugs.

One lawmaker in Berlin cited concerns about the cost weighing on an over-siretched health budget. The lawmaker, who did not want
to be named, said expert panels governing reimbursement would review any benefits of the drugs beyond just weight loss, the usual
system for approvals.

Michael Wirtz, who represents patients at advocacy group Obesity Help Germany, says this is short-sighted. Weight-loss drugs could
prolong lives and help people stay in the workforce.

"This is not about people needing to be lean and attractive,' he said.
Germany is not the only government to impose limits.

Public health insurance schemes in Norway and Denmark, the other two European countries where Wegovy is available, will not pay for
the drug, arguing that monthly costs of between $160 and $350 are too high compared to the benefits.

Denmark's largest private health insurer will also stop paying for it next year due to high demand.

French payment schemes will only cover its use for treating very obese people with a body mass index (BMI) of 35 or over, a higher
minimum than European regulators indicated when they approved the drug in January 2022.

Access in Britain will initially be through hospital specialists and limited to people with a BMI of 35 or over. The government plans to
authorise family doctors to prescribe the drug only after a two-year pilot scheme.

DIFFERENT PICTURE
In the United States, the federal Medicare health plan for older Americans is prohibited from covering weight-loss drugs.

Many health plans paid for by large employers will cover Wegovy, although they may require that patients try a rigorous diet programme
or cheaper drugs first.

'In Europe and the rest of the world, there is going to be much more variability,' said Terence McManus, fund manager at Switzerland-
based Bellevue Asset Management.

Barclays analysts estimate the global market for obesity drugs will increase to more than $60 billion by 2030 from $2.9 billion in 2022,
about 60% of which will be in the United States and around 26% in the European Union.

At present, around 53% of people across the 27-country EU are overweight or obese compared with roughly 74% in the United States,
although the EU statistics office has warned that weight problems are rapidly increasing in most member states.

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But for Europe's mostly universal health schemes, a surge in costs is a bigger fear than a rise in weight-related problems over time,
said Phil McEwan, CEO of health economics consultancy Heor in Cardiff, Wales, who advises Novo on market access.

"There are many more morbidly obese people in the U.S. You could argue they've got more to gain,' said McEwan.

lllumina Hit with Record $476 million EU Antitrust Fine Over Grail Deal

(Reuters) - U.S. genetic testing company lllumina was fined a record 432-million-euro by the EU on Wednesday for closing its takeover
of cancer test maker Grail before securing EU antitrust approval. [FN25]

lllumina has been fighting the EU competition watchdog on several fronts since it was forced to seek its approval in 2021 despite the
deal falling short of the EU turnover threshold for scrutiny.

The deal was eventually blocked last September, with regulators concerned that lllumina, once it had acquired Grail, would have an
incentive to cut off Grail's rivals from accessing its technology to develop blood-based early cancer detection tests to compete with
Grail.

The European Commission said lllumina's deliberate decision to jump the gun, because it thought the potential profits outweighed the
potential forced sale of Grail, underpinned the size of the fine - amounting to 10% of its global revenue and the maximum allowed under
EU merger rules for such infringements.

The Commission's decision confirmed a Reuters story in January.

Regulators had come up with a much higher figure but reduced it to $570 million to take into account lllumina's decision to hold Grail as
a separate company after closing the deal, an EU official said. That figure was then lowered to the 10% cap.

By closing the deal prematurely, lllumina was able to exercise a decisive influence over Grail, the EU enforcer said, calling the move
unprecedented and a very serious infringement.

'If companies merge before our clearance, they breach our rules. lllumina and Grail knowingly and deliberately did so by implementing
their tie-up as we were still investigating,' EU antitrust chief Margrethe Vestager said in a statement.

Grail was given a symbolic 1,000 euro fine for its active role in the infringement, the first time a target company has been sanctioned.

llumina criticised the fine as 'unlawful, inappropriate, and disproportionate' and said it would appeal the penalty. It has set aside $458
million, representing 10% of its consolidated annual revenue for fiscal year 2022, for the fine.

'We closed the transaction in 2021 because there was no impediment to closing in the U.S. and the deal timeframe would have expired
before the EC could reach a decision on the merits,' the company said in a statement.

'The deal timeframe relied on the EC's public statements that it would not assert jurisdiction over mergers of this type until new
guidelines were issued, yet the EC nonetheless asserted jurisdiction over the merger before issuing the promised guidelines.'

The company has challenged the EU veto of the deal, its decision to examine the deal despite not meeting the EU merger criteria and
the EU order to keep Grail separate so that it can unwind the deal.

It said success in the second case would nullify the EU fine and expects the EU court to rule in late 2023 or early 2024.
llumina has also appealed against a U.S. Federal Trade Commission order that it divest Grail.
Insurer Centene to Sell UK Unit to UAE's PureHealth in $1.2 billion Deal

(Reuters) - Centene said on Monday it will sell British hospital operator Circle Health Group to United Arab Emirates-based PureHealth
for about $1.2 billion including debt, as the U.S. health insurer refocuses on its core business. [FN26]

The acquisition will help PureHealth, which is the UAE's largest healthcare provider, enter the UK market in a deal that it said has the
potential to deliver wide-ranging benefits to the healthcare ecosystems of both countries.

'These benefits include the expansion of clinical knowledge and delivery of new medical techniques through enhanced collaboration
between medical professionals, as well as the use of cutting-edge technologies and provision of broadened treatment options for
patients in the UAE,' PureHealth said in a statement.

Founded in 2004, Circle Health is one of the UK's largest network of private hospitals with 54 establishments across the country.
U.S.-based health insurer Centene is undergoing a review of its portfolio and expects the deal to close in the first quarter of next year.
Centene first invested in UK-based Circle Health in 2019 and acquired its remaining equity in 2021.

PureHealth is majority-owned by Abu Dhabi investment fund ADQ, with International Holding Company also holding a stake. Both
ADQ and IHC are chaired by Sheikh Tahnoun bin Zayed Al Nahyan, the national security adviser and a brother of UAE ruler Sheikh
Mohammed bin Zayed.

The firm recently completed a 1.8 billion dirham ($490.12 million) purchase of an equity investment in Ardent Health Services, which is
a U.S.-based private healthcare group.

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Britain's First Supervised Drug-injection Site Approved
(Reuters) - Britain's first official supervised drug consumption room was approved on Wednesday, seeking to reduce infectious
diseases and overdoses in Scotland which suffers from the highest level of drug-related deaths in Europe. [FN27]

Following similar projects in Europe, Canada and Australia, Glasgow City Council, which runs the largest city in Scotland, approved
plans for the facility that will allow people to legally take illicit drugs under the supervision of trained professionals and will provide them
with clean equipment.

While opponents of these facilities say they end up as a magnet for drug abuse, supporters say they reduce overdose deaths caused
by increasingly potent street drugs, decrease public injecting and connect people to treatment services.

Allan Casey, a local politician in Glasgow who is responsible for addiction services, said research shows that no one has ever died from
an overdose in a supervised drug consumption room, while it will reduce the problem of public drug use that often means that used
syringes are left on the streets or in parks.

'What we have been doing clearly has not been working thus far,' he told Reuters. 'We need to move to an approach where this is a
public health issue and not a criminal justice one.'

This follows years of disagreement about whether a facility would be legal. The British government, which sets national drug policy
in England, Scotland, Wales and Northern Ireland, does not support the plans, but the idea was approved after Scotland's senior law
officer said users would not be prosecuted for possessing drugs while at the facility.

Scotland's drug deaths remain three times higher on a per capita basis than anywhere else in Europe, despite the country recording its
largest fall in fatalities in 2022.

Last year, Scotland had 248 drug deaths per million people aged between 15 and 65, compared with 79 in Finland, the second-worst
country in Europe, according to the European Monitoring Centre for Drugs and Drug Addiction.

Scotland has been dealing with a drug crisis for decades and its government wants to take a new approach to helping its residents with
drug-addiction issues. However, officials say it has been hindered by Britain's drug laws.

Scotland announced in July plans to decriminalise the possession of all drugs for personal use but said the British government in
London is opposed to those plans.

Pharma Lobby Says EU Ban on 'Forever Chemicals' Would Halt Drug Production

(Reuters) - European drugmakers warned that a proposed complete ban on substances known as PFAS or 'forever chemicals'
would render medicine production in the region impossible, part of a high-stakes wrangle between manufacturers and environmental

regulators. [FN28]

The European Union started to consider in February a ban of the widely used but potentially harmful substances, in what could become
the bloc's most extensive piece of regulation of the chemical industry.

A six-month consultation period to give impacted companies and industries an opportunity to put their views forward ended on Monday,
with the European Chemicals Agency (ECHA) registering 5,600 comments.

'The entire pharmaceutical industry would no longer be able to manufacture active pharmaceutical ingredients ... or associated
medicinal products in the EEA,' if no exemptions, or derogations, are included in the draft, the European Federation of Pharmaceutical
Industries and Associations (EFPIA) said in a statement.

The EEA, or European Economic Area, includes 27 EU member states plus Liechtenstein, Iceland and Norway.

'A total ban would see medicines' manufacturing in the EU grind to a halt in under three years,' said EFPIA's director general, Nathalie
Moll.

The group, which counts pharmaceutical majors with European operations including Pfizer, Roche and Novartis as members, said that
PFAS are used in drug production, and some PFAS with no or low identified risks go directly into medicines.

It does not oppose regulating certain harmful PFAS, the group added.

Among critical responses from other industries, the European chemical makers' association Cefic has called for 'balanced' regulation
of PFAS, saying a ban would hobble the production of batteries, semi-conductors, electric vehicles and renewable energy production,
among other products.

EFPIA said it had provided 'scientific and technical evidence to justify derogations and prevent medicine shortages' under ECHA's
consultation.

The moniker 'forever chemicals' stems from their ability to accumulate in water and soils because they do not decompose as a result of
an extremely strong bond between carbon and fluorine atoms.

The chemicals are in use in tens of thousands of products and machines, including cars, textiles, medical gear, windmills and non-stick
pans due to their long-term resistance to extreme temperatures and corrosion.

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But PFAS have also been linked to health risks like cancer, hormonal dysfunction and a weakened immune system as well as
environmental damage.

According to the planned EU regulation, companies would be given a transition period of 18 months and, in addition, up to 12 years to
find alternative substances, depending on the industry or product use.

GSK to Sell 2.9% Stake in Former Consumer Healthcare Business Haleon

(Reuters) - British drugmaker GSK said on Thursday it intends to sell a 2.9% stake, or about 270 million shares, in its spun-off
consumer healthcare business Haleon. N%!

The sale will bring down GSK's current 10.3% holding in the Sensodyne maker, which was spun out and listed on the London Stock
Exchange in July 2022.

GSK earlier this year sold 240 million shares in Haleon to raise about 804 million pounds ($1 billion), and lowered its stake from 12.9%
it initially retained in the business.

Haleon, the world's biggest standalone consumer health company, was formed in 2019 with the merger of GSK and Pfizer's consumer
healthcare businesses.

BofA Securities and Citigroup will act as joint global coordinators for the offering, and the companies have agreed not to dispose of any
shares in Haleon for a period of 60 days after the settlement of this offering, GSK said.

Pfizer, which holds a 32% stake in Haleon, said in May it plans to cut ownership in a 'slow and methodical' manner within months.
European Regulator Warns EU, UK About Fake Ozempic Pens

(Reuters) - Europe's medicines regulator on Wednesday warned about pre-filled pens falsely labelled as Novo Nordisk's popular
diabetes drug Ozempic at wholesalers in the European Union and the UK. [FN30]

"There is no evidence that any falsified pens have been dispensed to patients from legal pharmacies and there are no reports of harm to
patients in relation to the falsified medicine,' the European Medicines Agency (EMA) said.

Its UK counterpart, the Medicines and Healthcare products Regulatory Agency (MHRA), confirmed that falsely labelled pens of
Ozempic have been identified at two UK wholesalers.

Novo became one of Europe's most valuable companies this year on surging demand for its weight-loss drug Wegovy and diabetes
drug Ozempic amid a global obesity crisis.

Though only Wegovy is approved for obesity, the fact that Ozempic also leads to dramatic weight loss has led people in the United
States and Europe to use the drug 'off-label," meaning not for its approved use.

That has attracted illegal traders who may put user health at risk.

Novo last week warned of a surge in counterfeit versions of Wegovy and Ozempic offered online, after Germany's federal drug
regulator urged pharmacies and drug distributors to be vigilant following the discovery of wholesale batches of fake Ozempic.

While the pens with labels in German were fake, the packaging was genuine and they originated from wholesalers in Austria and
Germany, the EMA said in a statement on Wednesday.

'All affected pens have been recalled and accounted for, and none of the pens have been supplied to UK patients,' MHRA said.
Pfizer Wins Unconditional EU Antitrust Okay for $43 billion Seagen Buy

(Reuters) - U.S. pharmaceutical company Pfizer gained unconditional EU antitrust approval on Thursday for its proposed $43 billion
acquisition of cancer drug maker Seagen. [FN31)

Pfizer announced the deal in March, its largest purchase in a string of recent acquisitions thanks to a once-in-a-lifetime cash windfall
from its COVID-19 vaccine and treatment.

The European Commission said the deal would not significantly reduce competition in the 27-country European Union nor would it have
a negative impact on prices.

"The proposed merger would not raise competition concerns,' the EU antitrust watchdog said in a statement.

Washington-based Seagen is a pioneer of antibody-drug conjugates, which work like 'guided missiles' designed to destroy cancer while
sparing healthy cells.

V. GLOBAL ISSUES
WHO Still Working to Identify the Origins of COVID-19

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(Reuters) - The World Health Organization (WHO) is still working to identify the origins of the COVID-19 pandemic, its director general
said on Friday, after a U.S. agency was reported to have assessed the pandemic had likely been caused by a Chinese laboratory leak.
[FN32]

'l have written to and spoken with high-level Chinese leaders on multiple occasions as recently as just a few weeks ago... all
hypotheses on the origins of the virus remain on the table,' said WHO Director-General Tedros Adhanom Ghebreyesus.

The Wall Street Journal reported on Sunday that the U.S. Energy Department had concluded the pandemic likely arose from a Chinese
laboratory leak, an assessment Beijing denies.

'l wish to be very clear that WHO has not abandoned any plans to identify the origins of the COVID-19 pandemic,' Tedros said.

The U.S. Energy Department made its judgment with 'low confidence' in a classified intelligence report recently provided to the White
House and key members of Congress, the Journal said, citing people who had read the intelligence report.

Four other U.S. agencies, along with a national intelligence panel, still think COVID-19 was likely the result of natural transmission,
while two are undecided, the Journal reported.

Maria Van Kerkhove, the WHOQ's technical lead on COVID-19, expressed frustration on Twitter on Thursday that the United States had
not shared additional information with the WHO on its reports assessing the origin of the virus.

On Friday, she urged countries, institutions and research groups that might have any information on the origins of the pandemic to
share it with the international community.

'We don't completely have the answers to how this pandemic began and it remains absolutely critical that we continue to focus on this,'
she said.

She said it was crucial to study coronaviruses circulating in animals and how people come into contact with those animals.

'Our work continues on this space: looking at studies in humans, looking at studies in animals, looking at studies at the animal human
interface, and also looking at potential breaches in biosafety and biosecurity for any of the labs that were working with coronaviruses,
particularly where the first cases were detected in Wuhan, China, or elsewhere,' she said.

WHO Revises COVID-19 Vaccine Recommendations for Omicron-era

(Reuters) - The World Health Organization has tailored its COVID-19 vaccination recommendations for a new phase of the pandemic,
suggesting that healthy children and adolescents may not necessarily need a shot but older, high-risk groups should get a booster

between 6 to 12 months after their last vaccine. [FN33]

The U.N. agency said the aim was to focus efforts on vaccinating those facing the greatest threat of severe disease and death from
COVID-19, considering the high-level population immunity worldwide due to widespread infection and vaccination.

The health agency defined high-risk populations as older adults, as well as younger people with other significant risk factors. For this
group, the agency recommends an additional shot of the vaccine either 6 or 12 months after the latest dose, based on factors such as
age and immunocompromising conditions.

Meanwhile, it said healthy children and adolescents were 'low priority' for COVID-19 vaccination, and urged countries to consider
factors like disease burden before recommending vaccination of this group. It said the COVID-19 vaccines and boosters were safe for
all ages, but the recommendations took into account other factors like cost-effectiveness.

The WHO said in September last year that the end of the pandemic was 'in sight'. In a briefing on Tuesday, the agency said its latest
advice reflected the current disease picture and global immunity levels, but should not be seen as long-term guidance over whether
annual boosters would be needed.

The recommendations come as countries take differing approaches. Some high-income countries like the United Kingdom and Canada
are already offering those at high-risk COVID-19 boosters this spring, six months after their last dose.

'The revised roadmap re-emphasises the importance of vaccinating those still at-risk of severe disease,' said Hanna Nohynek, chair of
the WHO's Strategic Group of Experts on immunisation, which made the recommendations.

The committee also called for urgent efforts to catch up. on routine vaccinations missed during the pandemic and wamed of a rise in
vaccine-preventable diseases like measles.

For COVID, it said that vaccines beyond the initial two shots and a booster were no longer routinely recommended for those at 'medium
risk' as benefits were marginal.

Pfizer Pledge for More Equal Access to RSV Shot Faces Hurdles

(Reuters) - Pfizer Inc has pledged to deliver critical new medicines more quickly in low-income nations, but its first such vaccine effort
faces hurdles likely to delay distribution in poorer countries by several years, global health officials told Reuters. [FN34]

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Pfizer made a commitment on more equitable access last year, following criticism that it prioritized wealthy nations for doses of its
COVID-19 shot early in the pandemic. The company says it wants to shorten a timeline in which poorer countries often get vaccines
many years after they are available elsewhere.

The drugmaker received a $28 million grant from the Bill and Melinda Gates Foundation in September to support the launch of the
respiratory syncytial virus vaccine in poorer countries, where RSV - a common cold-like virus - is much more likely to be lethal for very
young children.

Pfizer's maternal RSV vaccine is expected to be approved for use in pregnant women in August in the United States and several
months later in Europe, and the company plans to launch the product in both markets in the fall. Its peak sales forecast is of more than
$2 billion annually together from the matemal vaccine and an RSV shot for older adults.

But the vaccine will need a different delivery system to be used in developing countries in Africa and Asia, including alternative
packaging and syringes. Preparations for those modifications are just beginning, according to the World Health Organization and the
company - which is likely to push back delivery by several years.

The case highlights how equitable global access will require better advance planning by drugmakers, governments and health
organizations, health officials say.

"They could have tried sooner,' said Erin Sparrow, WHO's technical officer for the RSV vaccine, referring to Pfizer. 'It's a little bit
disappointing, but they are doing the right thing now.'

Pfizer says it is committed to a faster timeline for rolling out medicines to poor nations but acknowledges that there are challenges in
meeting such goals.

'We are committed to working with the appropriate organizations, including regulatory authorities and other global health partners, to
help ensure the vaccine candidate, once approved, is available in lower- and middle-income countries as quickly as possible,' a Pfizer
spokesperson said when asked about the timeline for the RSV shot.

In an interview last month, Pfizer's head of vaccines research and development Annaliesa Anderson said the company still aimed to
make its vaccine - the first of its kind - available for pregnant women in low-income countries more or less in the 'same time frame' as in
wealthy countries.

It had pledged last May to offer its existing portfolio, as well as newly developed drugs and vaccines, at a not-for-profit basis to 45
lower-income countries on a faster timeline than in the past.

The company had learned during the COVID-19 pandemic that 'parallel development' to meet the needs of different regions was
possible, Anderson said.

LEARNING CURVE

Rates of RSV have surged since the pandemic. Inoculating pregnant women against RSV can protect babies from the virus that kills
nearly 100,000 children worldwide each year.

Most of those children are under five years old, with 98% living in low and middle-income countries that have fewer healthcare
resources to treat the infection.

Pfizer has yet to take a number of steps needed to make the vaccine available in developing countries, according to global health
officials and the company.

They include seeking approval for the shot from the WHO, whose authorization is used by governments that don't have a strong
domestic drugs regulator, and by nonprofits - such as the global vaccine alliance Gavi - that fund purchases in low-income countries.

Early discussions with the WHO are underway, but the process will be complicated because Pfizer's RSV vaccine is not designed for
syringes that automatically disable after one injection, which are preferred by the health agency for safety reasons to prevent reuse.

In addition, the RSV shot is currently only available in a single-dose vial. In lower-resource settings, multi-dose vials are often used
because they are cheaper and simpler to distribute.

Multi-dose vials require the addition of a preservative, which means the manufacturer needs to run new trials to ensure there is no
impact on the vaccine's safety or efficacy.

The Gates grant will be used to fund trials of a multi-dose vial, which are likely to begin next year and may take another year to
complete, a source with knowledge of the plans said.

A Gates Foundation official said that the investment in the RSV program represented a learning process for the organization and the
company on the steps needed for more equitable access.

They have already reached a partnership for a maternal vaccine in earlier stages of development against Group B Streptococcus,
which kills around 90,000 babies a year and causes 46,000 stillbirths, over half of them in sub-Saharan Africa.

'We very much want to see that time gap [between high and low-income countries] reduced, such that there's no space between the
two,' said Padmini Srikantiah, lead on the RSV vaccine launch at Gates.

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She still expects it to be several years before the RSV vaccine is launched in lower-income countries.
'l think we're doing better than in years before,' she said. 'It's a process.'
WHO Declares End to COVID Global Health Emergency

(Reuters) - The World Health Organization ended the global emergency status for COVID-19 on Friday more than three years after its
original declaration, and said countries should now manage the virus that killed more than 6.9 million people along with other infectious

diseases. [N

The global health agency's Emergency Committee met on Thursday and recommended the UN organization declare an end to the
coronavirus crisis as a 'public health emergency of international concern' - its highest level of alert - which has been in place since Jan.
30, 2020.

'It is therefore with great hope that | declare COVID-19 over as a global health emergency,' said WHO Director-General Tedros
Adhanom Ghebreyesus, adding that the end of the emergency did not mean COVID was over as a global health threat.

During a lengthy conference call to brief the press on the decision, some WHO members became emotional as they urged countries to
reflect on lessons leared during the pandemic.

'We can't forget those fire pyres. We can't forget the graves that were dug. None of us up here will forget them,' said WHQ's technical
lead on COVID-19 Maria Van Kerkhove.

The COVID death rate has slowed from a peak of more than 100,000 people per week in January 2021 to just over 3,500 in the week
to April 24, 2023, according to WHO data, reflecting widespread vaccination, availability of better treatments and a level of population
immunity from prior infections.

Ending the emergency could mean that international collaboration or funding efforts are also brought to an end or shift in focus,
although many have already adapted as the pandemic receded in different regions.

'The battle is not over. We still have weaknesses and those weaknesses that we still have in our system will be exposed by this virus or
another virus. And it needs to be fixed,' said the WHO's emergencies director Michael Ryan.

The WHO does not declare the beginning or end of pandemics, although it did start using the term for COVID in March 2020.
'In most cases, pandemics truly end when the next pandemic begins,' Ryan said.

Last year, U.S. President Joe Biden said the pandemic was over. Like a number of other countries, the world's biggest economy has
begun dismantling its domestic state of emergency for COVID, which officially ends May 11, meaning it will stop paying for vaccines
and testing for many people and shift responsibility to the commercial market.

The European Union also said in April last year that the emergency phase of the pandemic was over, and other regions have taken
similar steps.

'SIGNIFICANT PUBLIC HEALTH PROBLEM'

The WHO's declaration comes just four months after China ended its prolonged severe COVID restrictions and was ravaged by a big
surge in infections.

The decision also suggests that WHO advisers believe a new more dangerous coronavirus variant is unlikely to emerge in the coming
months, although the virus remains unpredictable.

'l will not hesitate to convene another emergency committee should COVID-19 once again put our world in peril', WHO chief Tedros
said.

In many parts of the world, testing has dwindled dramatically, and people have largely stopped wearing masks. In some countries,
mask-wearing mandates have resumed during COVID outbreaks. The WHO published a plan this week advising countries on how to
live with COVID long-term.

COVID will continue to challenge health systems worldwide long term, including long COVID, infectious disease experts say. 'No one
should take (this) to mean COVID-19 is no longer a problem," said Mark Woolhouse, an epidemiologist at the University of Edinburgh.

"It is still a significant public health problem and looks likely to remain one for the foreseeable future.'

WHO Warns Against Bias, Misinformation in Using Al in Healthcare

(Reuters) - The World Health Organization called for caution on Tuesday in using artificial intelligence for public healthcare, saying data
used by Al to reach decisions could be biased or misused. [FN36]

The WHO said it was enthusiastic about the potential of Al but had concerns over how it will be used to improve access to health
information, as a decision-support tool and to improve diagnostic care.

The WHO said in a statement the data used to train Al may be biased and generate misleading or inaccurate information and the
models can be misused to generate disinformation.

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It was 'imperative' to assess the risks of using generated large language model tools (LLMs), like ChatGPT, to protect and promote
human wellbeing and protect public health, the U.N. health body said.

Its cautionary note comes as artificial intelligence applications are rapidly gaining in popularity, highlighting a technology that could
upend the way businesses and society operate.

Demand for Weight-loss Drugs Fuels Global Rise in Counterfeits
(Reuters) - Extraordinary demand for Novo Nordisk's Ozempic and other drugs used for weight-loss is fueling a global surge in
counterfeit versions, according to Reuters interviews with law enforcement, anti-counterfeiting and public health officials. [FN37]

The U.S.-based Pharmaceutical Security Institute (PSI), an industry-backed organization that counts drugmakers Novo Nordisk and Eli
Lilly as members, said it is working with agencies, including Europol, Interpol and U.S. Homeland Security, as well as companies that
help identify counterfeit products such as Israel's BrandShield.

Their combined efforts include opening inquiries into complaints of fake drugs, trolling e-commerce and social media for purchase offers
or advertisements and teaching customs officials how to spot counterfeits.

Novo's Ozempic, approved to treat diabetes, contains the active ingredient semaglutide, which is also used in the company's weight
loss drug, Wegovy.

Both are being used by people seeking to shed pounds, as is Lilly's Mounjaro, which is currently approved for diabetes and expected
to get a green-light from the U.S. Food and Drug Administration to treat obesity in the coming months. All three medicines are in short
supply amid a global obesity epidemic and high rates of diabetes.

"These weight loss drugs are a hot topic right now because they're on TV and getting a lot of media attention. If I'm a criminal
organization, that's the next opportunity | go ahead and exploit," said Jim Mancuso, director of the U.S. Department of Homeland
Security's Intellectual Property Rights Coordination Center.

Mancuso said the agency is also working with Europol, Interpol and around 23 other law enforcement agencies on tracking weight-
loss drugs to quell what they believe could become the worst tide of counterfeit lifestyle medicines since erectile dysfunction drugs like
Viagra.

Though Novo stresses that its medicines Ozempic and Wegovy are indicated for the treatment of diabetes and weight-loss,
respectively, the weekly injection drugs have become household names in America for their use off-label as lifestyle treatments.

Novo said in a statement to Reuters that it works closely with PSI and other organisations to "share data accurately and provide an
informed picture on the status of these crimes," and collaborates with law enforcement and other authorities.

Lilly said its strategy includes deterring major counterfeiters of its products through investigations, internet monitoring and legal actions
and partnering with government and non-government organizations and trade associations.

'SO MANY CASES'

Ozempic is the biggest target so far in Europe, according to a Europol official who requested anonymity because he was not authorized
to speak. Fake weight-loss drugs will be a key focus in the agency's annual counterfeit medicines report, due next year, the official said.

"We have counterfeit products and stolen products," the official said. "We have so many cases."

Counterfeit Ozempic has already been found in at least 14 countries, including the UK, Germany, Egypt and Russia. Several have
issued warnings to pharmacies and consumers to be vigilant about counterfeits, since it is not clear what they actually contain.

Germany's federal drug regulator last week urged pharmacies and drug distributors to be vigilant following the discovery of wholesale
batches of fake Ozempic.

Britain's regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), then said on Wednesday that injection pens
falsely labelled as Ozempic had been identified at two UK wholesalers.

A World Health Organization spokesperson said use of such drugs could pose significant health risks.

"We will look online and if we find something that infringes (obesity drug trademarks) we'll get it taken down," said Yoav Keren,
BrandShield CEO. "Sometimes PSI and its members will do sample purchases," he said. When a consumer buys those fakes, "what
you get are expired drugs, counterfeit drugs, or nothing," he added.

An officer for Interpol said that counterfeit obesity drugs because of their high prices are largely being sold in affluent countries,
including those in North America, Europe and the Middle East, unlike most fake drugs that tend to be marketed in poorer regions.

MHRA said reports related to potentially falsified GLP-1s, the class of drug that includes Wegovy, Ozempic and Eli Lilly's diabetes drug
Mounjaro, had risen from two in 2022 to as many as 20 this year.

Ireland's Health Products Regulatory Authority told Reuters that it has confiscated 233 units of counterfeit semaglutide compared with
32 units in 2022.

Italy Arrests Six in Crackdown on Fentanyl Smuggling from China to U.S.

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(Reuters) - Italian police have arrested six people in a crackdown on a network that allegedly played go-between for fentanyl trafficking
from China to the United States, Guardia di Finanza police and prosecutors in the northern city of Piacenza said on Wednesday. [FN38]

'It was really good work, achieved through direct cooperation with investigators from the U.S. Drug Enforcement Administration (DEA),'
Piacenza chief prosecutor Grazia Pradella told Reuters, adding that U.S. police arrested 11 other people and seized 2 kg of the
synthetic drug.

Washington is hoping to secure more cooperation from Beijing in combating production of the potent synthetic opioid fentanyl, a
scourge in the United States, when President Joe Biden meets Chinese President Xi Jinping on Wednesday.

The rate of drug overdose deaths involving fentanyl more than tripled from 2016 through 2021 in the U.S., according to the U.S.
Centers for Disease Control and Prevention (CDC).

Among those arrested in Italy is the alleged head of the network, a 51-year-old Italian man suspected of buying fentanyl from China
over the past three years. He sold it on to buyers in the United States, and in one case in Mexico, the chief prosecutor said.

The investigation began in April after a report sent by the DEA liaison officer at the U.S. embassy in Rome, Guardia di Finanza police
said in a statement, adding the fentanyl arrived in Piacenza inside packages sent from China and labelled as containing electronics or
books.

Police said they were able to trace 100,000 packaged doses and that related economic transactions amounting to more than 250,000
euros ($275,000) took place through untraceable payment instruments using cryptocurrency.

The judge in Piacenza had ordered seven arrests but a Ukrainian national is a fugitive and international law enforcement agencies have
been alerted to track him down, police said.

Italian police also found that the group had minted near-perfect fake Swiss coins, smuggled them across the border to Switzerland
where they laundered them through automated sports betting machines and bitcoin ATMs.

The conversion of bitcoins back into euros was then entrusted to people in Eastern Europe who would return the 'cleaned' sum minus
7% commission to the counterfeiter in Piacenza.

Police said they seized 300,000 euros in cash, about 26,000 euros in bitcoin, 70 computer devices and three valuable watches, as well
as a property and the equipment for counterfeiting currency.

AIDS Response 'Under Threat' Amid Human Rights Backlash - UN
(Reuters) - The global response to AIDS is 'under threat' because of an unprecedented backlash against human rights that is
stigmatizing the groups most at risk of HIV infection, the head of the United Nations AIDS programme has wammed. [FN39]

Winnie Byanyima, executive director of UNAIDS, said countries where there are laws against LGBTQ people, or which criminalise sex
work or personal drug use, are largely the places seeing a rise or plateau in new infections.

Stigma, discrimination and a lack of comprehensive sex education was also an issue, she said.

'This pushback - anti-human rights, anti-democratic, anti-gender equality - has put our work under threat,' she told Reuters in an
interview in London ahead of the launch of a new report from the organization she leads.

UNAIDS is aiming for a target of ending the disease as a public health threat by 2030, which Byanyima said was still achievable, with
a number of countries, particularly in Africa on track or close to their targets. But in other regions like eastern Europe and north Africa,
infections are on the rise.

'We are saying it can be achieved. That's not the same as saying it will be achieved,' she said.

Globally, there were 39 million people living with HIV in 2022, including 1.3 million who were newly infected. Almost 30 million of them
are getting treatment, but there were still 630,000 deaths due to AlIDS-related illnesses last year, according to UNAIDS data.

The new report calls for the work of community organizations to be recognised and funded to help fight stigma and the wider backlash,
under the title 'Let communities lead.'

Byanyima said there were also other challenges, such as funding and 'big battles' with pharmaceutical companies to ensure that new
products can be made available in low-income countries at an affordable price.
V1. MIDDLE EAST/NORTH AFRICA

U.N. and Medical Agencies Condemn Israel''s Gaza Ambulance Strike
(Reuters) - The United Nations Secretary General and aid agencies working in Gaza have condemned Israel's air strike on an
ambulance on Friday, which the Israeli military said, without showing evidence, was carrying Hamas militants. [FN40]

The Health Ministry, a hospital director and the Palestinian Red Crescent Society in the Hamas-controlled enclave have said the Israeli
strike targeted a convoy of ambulances evacuating wounded people from the besieged northern Gaza area.

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Mohammad Abu Selmeyah the director of al-Shifa Hospital, where an ambulance was hit, said 15 people had been killed in the strike
and 60 injured. Those killed and injured were mainly people standing by the hospital gate, rather than inside the vehicles, he said.

Israel's military said late on Friday it would present more evidence that an ambulance it struck was being used by Hamas to transport
fighters and that the group used ambulances to move militants and weapons as 'a method of operation'. Hamas has denied both
accusations.

U.N. Secretary General Antonio Guterres said in a social media post on Saturday 'l am horrified by the reported attack in Gaza on an
ambulance convoy.'

The World Health Organisation said it condemned the strike and the medical charity Medicins Sans Frontieres described it as
'horrendous,' and 'a new low in an endless stream of unconscionable violence.'

The Palestinian Red Crescent Society (PCRS) said in a statement that a group of five ambulances was seeking to transport people
wounded by Israeli bombardment from al-Shifa Hospital in Gaza City to the Rafah border crossing with Egypt.

The journey would have required crossing from the northern half of the enclave, which has now been entirely surrounded by Israeli
forces, into the southern area where Israel has not yet sent ground troops, but which it is also bombarding.

Abu Selmeyah said the wounded people being evacuated in the convoy had their names listed at Rafah for permission to enter Egypt.
Egypt's Health Ministry did not immediately respond to a Reuters request for comment but a statement it put out on Friday said that 28
injured people had been expected at Rafah on that day.

EVACUATION

Israel's military assault, aimed at destroying Hamas, is a response to the militant group's Oct. 7 attack on Israeli towns which Israel
says killed 1,400 people. Health authorities in Hamas-run Gaza say Israeli bombardment has killed 9,488 people.

The PRCS said Friday's ambulance convoy was forced to tum back some 4 km (2.6 miles) from the hospital because the road was
blocked with rubble from shelling.

As it returned through Gaza City, about 1km from the hospital, the lead ambulance was targeted by a missile that damaged it, wounding
both its crew and the injured patient inside, the PCRS said.

The organisation said it was responsible for one of the five ambulances in the convoy carrying a 35-year-old woman with shrapnel
injuries. It said as it was unloading the woman from the ambulance at the hospital gate, another missile struck the vehicle injuring the
driver and a medic.

Videos verified by Reuters of the aftermath showed numerous people lying prone in pools of blood near ambulances.

MSF quoted one of its doctors working at al-Shifa hospital, whom it identified as Dr. Obaid, saying 'We were standing inside the hospital
gate when the ambulance was directly hit in front of us. There were bloody bodies everywhere.'

Israel's military assault, aimed at destroying Hamas, is a response to the militant group's Oct. 7 attack on Israeli towns which Israel
says killed 1,400 people. Health authorities in Hamas-run Gaza say Israeli bombardment has killed 9,488 people.

The PRCS said Friday's ambulance convoy was forced to turn back some 4 km (2.6 miles) from the hospital because the road was
blocked with rubble from shelling.

As it returned through Gaza City, about 1km from the hospital, the lead ambulance was targeted by a missile that damaged it, wounding
both its crew and the injured patient inside, the PCRS said.

The organisation said it was responsible for one of the five ambulances in the convoy carrying a 35-year-old woman with shrapnel
injuries. It said as it was unloading the woman from the ambulance at the hospital gate, another missile struck the vehicle injuring the
driver and a medic.

Videos verified by Reuters of the aftermath showed numerous people lying prone in pools of blood near ambulances.

MSF quoted one of its doctors working at al-Shifa hospital, whom it identified as Dr. Obaid, saying 'We were standing inside the hospital
gate when the ambulance was directly hit in front of us. There were bloody bodies everywhere.'

Asked about the incident, a spokesperson for the International Committee of the Red Cross in Geneva said 'we are heartbroken to see
medical services in Gaza put in harm's way'.

The ICRC spokesperson said the Palestinian Red Crescent Society, which said it owned one of the ambulances in the convoy, has 'a
strong track record providing lifesaving services. Like all the organisations forming part of the Red Cross Red Crescent Movement they
are bound by principles of neutrality and impartiality.'

Israeli Tanks Outside Gaza Hospital, Biden Hopes for 'Less Intrusive' Action

(Reuters) - Israeli tanks advanced on Monday to the gates of Gaza City's main hospital, a chief target in Israel's battle against Hamas,
as U.S. President Joe Biden said hospitals must be protected and he hoped for less intrusive Israeli action. [FN41]

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Separately, the armed wing of the Palestinian militant group said it was ready to release up to 70 women and children held in Gaza in
exchange for a five-day truce in the war triggered by Hamas' Oct. 7 rampage into southern Israel.

Gaza health ministry spokesperson Ashraf Al-Qidra, who was inside Al Shifa hospital, said 32 patients had died in the last three days,
including three newborn babies, as a result of the siege of the hospital in northern Gaza and a lack of power.

At least 650 patients were still inside, desperate to be evacuated to another medical facility. Israel says the hospital sits atop tunnels
housing a headquarters for Hamas fighters using patients as shields, which Hamas denies.

'The tanks are in front of the hospital. We are under full blockade. It's a totally civilian area. Only ... hospital patients, doctors and other
civilians staying in the hospital. Someone should stop this,' a surgeon at the hospital, Dr Ahmed El Mokhallalati, said by telephone. 'We
are hardly surviving.'

In his first comments since the weekend's events, including patient deaths reported at the Shifa hospital, Biden said that hospitals must
be protected.

'My hope and expectation is that there will be less intrusive action relative to hospitals and we remain in contact with the Israelis,' Biden
told reporters at the White House.

'Also there is an effort to get this pause to deal with the release of prisoners and that's being negotiated, as well, with the Qataris ...
being engaged,' he added. 'So | remain somewhat hopeful but hospitals must be protected.'

Israel launched its campaign last month to annihilate Hamas, the Islamist group that runs the Gaza Strip and that is officially dedicated
to the destruction of Israel, after Hamas gunmen rampaged through southern Israel killing civilians.

Around 1,200 people died in that attack and 240 were dragged to Gaza as hostages according to Israel's tally.

Since then thousands of Gazans have been killed and two-thirds of the population have been made homeless by an Israeli military
campaign. Israel has ordered the evacuation of the northem half of Gaza.

Gaza medical authorities say more than 11,000 people have been confirmed killed, around 40% of them children.

Israel says Hamas hospitals serve as military facilities and Israel's military on Monday released video and photos of what it said were
weapons the group stored in the basement of Rantissi hospital, a pediatric hospital specializing in cancer treatment.

HOSTAGES FOR CEASEFIRE?

Al-Qassam Brigades, the armed wing of Hamas, posted an audio recording on its Telegram channel saying the group was ready to
release some of the hostages it took in exchange for a five-day ceasefire, an offer Israel is unlikely to embrace.

'The enemy has asked for the release of 100 women and children from his captives in Gaza but we told the mediators that in a five-day
truce, we can release 50 of them and the number could reach 70 due to the difficulty that the captives are held by different factions,' al-
Qassam Brigades spokesman Abu Ubaida said, referring to a request by Israel.

The spokesman said the Qatari mediators last week sought the release of some of the women and children hostages in return for Israel
freeing 200 Palestinian children and 75 women it detains.

"The truce should include a complete ceasefire and allow aid and humanitarian relief everywhere in the Gaza Strip,' he said.

White House national security adviser Jake Sullivan told reporters that Washington would 'like to see considerably longer pauses -
days, not hours - in the context of a hostage release.'

Speaking on condition of anonymity, another U.S. official said the release of dozens of hostages, could lead to a several-day pause,
saying negotiations were extremely delicate.

Israel, which effectively blockades Gaza, has rejected a ceasefire, arguing that Hamas would simply use it to regroup, but has permitted
brief humanitarian 'pauses' that have allowed food and other supplies to flow in and foreigners to flee.

Fighting also took place on Monday at a second major hospital in northern Gaza, al-Quds, which has stopped functioning. The
Palestinian Red Crescent said the hospital was surrounded by heavy gunfire, and a convoy sent to evacuate patients and staff had
been unable to reach it.

Israel said it had killed 'approximately 21 terrorists' at al-Quds in return fire after fighters shot from the hospital entrance. It released
footage it said showed a group of men at the hospital gate, one of whom appeared to be carrying a rocket-propelled grenade launcher.

In a sign of Israel's advance in Gaza, the country's Channel 12 TV broadcast a photo of soldiers carrying Israeli flags in the Gaza
parliament chamber. Israeli security cabinet minister Israel Katz said on X social media that the picture showed 'the symbol of Hamas
rule in Gaza' was in the hands of Israeli soldiers.

Israel's military and security services said they had killed a number of Hamas commanders and officials in the last day, including
Mohammed Khamis Dababash, who they described as the group's former head of military intelligence.

Hamas media said more than 30 people were killed and scores injured in an Israeli airstrike on the Jabalia refugee camp in northern
Gaza. An Israeli military spokesperson said the army was checking the report on Jabalia.

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In Israel, sirens sounded across the centre of the country and in the city of Tel Aviv on Monday night, with Hamas' armed wing saying
on its Telegram account that it had fired a batch of missiles at Tel Aviv.

There was also fresh concern that the war could spread beyond Gaza, with an upsurge of clashes on Israel's northern border with
Lebanon, and the United States launching airstrikes on Iran-linked militia targets in neighbouring Syria.

HOSPITAL AT HEART OF BATTLES

At Al Shifa, Gaza health ministry spokesperson Qidra said Israeli snipers and drones were firing into the hospital, making it impossible
for medics and patients to move around.

Israel has told civilians to leave and medics to send patients elsewhere. It says it has attempted to evacuate babies from the neo-natal
ward and left 300 litres of fuel to power emergency generators at the hospital entrance, but the offers were blocked by Hamas.

Qidra said Shifa needed 8,000-10,000 litres (2,100-2,600 gallons) of fuel per day delivered by the Red Cross or an international
agency.

© Copyright Thomson/West - NETSCAN's Health Policy Tracking Service

 

[FN2]
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[FN3]

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[FN4]
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[FN5]

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[FN8]

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[FN7]

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[FN8]

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[FN9]

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[FN10]
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[FN11]
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[FN12]
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[FN13]
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[FN14]
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[FN15]
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[FN16]
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[FN17]

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[FN18]

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[FN19]

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[FN20]

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[FN21]

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[FN22]

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[FN23]

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[FN24]

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[FN25]

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[FN26]

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[FN27]

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[FN28]

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[FN29]

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[FN30]
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[FN31]
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[FN32]
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[FN33]
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[FN34]
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[FN35]
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[FN36]
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[FN37]
. Patrick Wingrove and Maggie Fick, Demand for weight-loss drugs fuels global rise in counterfeits, Reuters (October 20, 2023).

[FN38]
. Emilio Parodi, ltaly arrests six in crackdown on fentanyl smuggling from China to U.S., Reuters (November 15, 2023).

[FN39]

. Jennifer Rigby, AIDS response 'under threat' amid human rights backlash - UN, Reuters (November 28, 2023).

[FN40]
. Nidal Al-Mughrabi, U.N. and medical agencies condemn Israel's Gaza ambulance strike, Reuters (November 4, 2023).

[FN41]

. Nidal Al-Mughrabi and Dan Williams, Israeli tanks outside Gaza hospital, Biden hopes for 'less intrusive' action, Reuters (November
13, 2023).

Produced by Thomson Reuters Accelus Regulatory Intelligence 17-Jan-2024

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