Tag - Generics and biosimilars

UK pharmacists report major aspirin shortage
Pharmacies across the U.K. are reporting widespread shortages of aspirin, one of the most widely prescribed drugs that is used to prevent heart attacks and strokes and treat pain. From a survey of 540 pharmacies, 86 percent had been unable to supply the medication to their patients in the past week, the National Pharmacy Association said Friday. Pharmacies said they have been rationing supplies, prioritizing patients with the most acute heart conditions or in need of emergency prescriptions, with several saying they stopped selling the medication over the counter. Olivier Picard, chair of the NPA, said the association is “concerned” about these reports and its implications on patients; 51 million aspirin items were prescribed in the U.K. between January and October last year. “For those pharmacies that can get hold of supply, costs will far exceed what they will be reimbursed by the [National Health Service], yet more signs of a fundamentally broken pharmacy contract in desperate need of reform by the government,” Picard said. Earlier this month, U.S. President Donald Trump made headlines for saying he takes a high daily dose of aspirin as it’s “good for thinning out the blood, and I don’t want thick blood pouring through my heart.” He reportedly takes four times the recommended daily dose for cardiovascular disease prevention. On Thursday, Trump blamed the medication for his visible hand bruise at Davos. In the U.K., pharmacists cannot offer patients substitutions for a prescribed medication, such as a different strength or formulation, without a new doctor’s prescription. The government is looking into the possibility of changing this. “We’ve long called for pharmacists to be able to make substitutions where a medicine is not in stock and it is safe to supply an alternative,” he said. “The status quo is not only frustrating for patients, it is also dangerous.” The government added aspirin to its export ban list on Jan. 16 amid the ongoing shortage. In the EU, the Pharmaceutical Group of the European Union said Friday they “don’t have any signal regarding shortages of aspirin in the EU.” The European Medicines Agency, which monitors drugs in short supply, does not currently list aspirin.
Health Care
Medicines
Public health
Prevention
Patients
Cypriot drugmaker denies involvement in corruption allegations
A drugmaker named in an alleged corruption scandal in Cyprus has denied making any political donations to the country’s president to protect a Russian businessman from EU sanctions. Cyprus has been plunged into political turmoil just as it assumed the leadership of the Council of the EU, a role which is crucial to the bloc’s political functioning. It is now having to defend itself against allegations senior officials accepted cash to help companies avoid sanctions as well as to bypass campaign spending caps. In a video released on X last week, Cypriot former energy minister Giorgos Lakkotrypis is apparently seen claiming that Remedica, a Limassol-based generics firm, had paid €75,000 to President Nikos Christodoulides so that he would speak in support of Andrei Kosogov. Kosogov is a co-founder of LetterOne, Remedica’s parent company. Two other Russian businessmen at LetterOne have already been sanctioned: Mikhail Fridman and Petr Aven, also co-founders, were sanctioned by the EU and U.K. in March 2022. “Remedica has not engaged in any discussions with the Cypriot government regarding concerns about EU sanctions related to individuals associated with LetterOne,” the generics firm said, adding: “Neither LetterOne nor Remedica have made any political donations to President Christodoulides’ administration.” The government has denied the allegations made in the video and calls it “hybrid activity” aimed at harming “the image of the government and the country.” Investigators are examining whether the X video was from a sting operation by people posing as investors, reported Phile News. Kosogov is not named on the EU sanctions list. There is no record in any public debates or meetings’ minutes at the European Commission, Parliament or Council of officials discussing Kosogov with regard to a possible EU sanction; his name is mentioned only in a June 2025 EU court judgement regarding another sanctioned individual, German Khan, who transferred ownership of his stakes in LetterOne and Russia’s Alfa Bank to Kosogov. Renew MEP Sandro Gozi has written to the Commission asking which position Cyprus took during discussions on the possible inclusion of Kosogov on the sanctions list and “whether representations were made in his favour” by Cypriot representatives, reported Cyprus Mail. In July 2025, Remedica donated €75,000 to the Cypriot government to support “wildfire relief efforts” in Cyprus. “LetterOne did respond to Cyprus’ public call for support for those affected by last year’s devastating wildfires, which also impacted Remedica employees,” Remedica told POLITICO. Asked if this was something the company would usually do, Remedica said that it had also provided “in-kind support during times of national need,” including donating ten new ventilators to the State Health Services Organisation in October 2020, to support the country’s health care system during the Covid-19 pandemic. “LetterOne has made similar donations in other markets where natural disasters have had an impact on staff in Portfolio companies — for example, the terrible flooding in Valencia, Spain, (where LetterOne has a substantial interest in Dia Supermarkets),” Remedica added.
Corruption
Health Care
Generics and biosimilars
How the EU’s stack of health files was a big win for industry
Faced with an ageing population and rising chronic disease rates, Europe wants to make its citizens healthier. It also needs to keep its most powerful industries happy. In the basket of health policies that EU lawmakers rushed to get across the line before Christmas, industry was the big winner: The pharmaceutical, food and drink sectors walked away with a set of major policy wins — and (potentially) healthier profits. While the pharma industry previously feared losing some of its monopoly rights on new drugs, the Commission this month offered it an extra year of patent protection for novel biotech drugs — among the most expensive treatments in the world. The food and drink sectors, meanwhile, successfully pushed back against proposals to tax ultra-processed foods and alcopops, for now. On Dec. 16 the Commission published its Biotech Act and Safe Hearts Plan, which landed just days after a long-awaited update of the pharmaceutical legislation. Taken together, they seek to incentivize industries to innovate and do business in Europe, improve access to medicines, and tackle the burden of cardiovascular disease. The pharma industry broadly celebrated the biotech proposal. The Biotech Act “reflects priorities we’ve intensively advocated to keep Europe globally competitive in life sciences,” Ognjenka Manojlovic, head of policy at European pharmaceutical company Sanofi, told POLITICO. That includes accelerating clinical trials, boosting intellectual property, and strengthening financing for Europe’s biotech ecosystem, Manojlovic said. The pharmaceutical sector had pushed for longer monopoly rights in the pharma legislation. In the end they were kept at the current standard eight years — instead of being cut by two years as the European Commission had initially proposed. For Europe’s public health insurers, who pay for drugs, the decisions taken to maintain and then extend market protections for medicines are hard to square. “We are puzzled by the Commission’s intentions,” said Yannis Natsis, director of the European Social Insurance Platform, a network of Europe’s social insurance organizations, warning that taxpayers will have to pick up the bill. Meanwhile, health campaigners are also unhappy at the Commission’s “missed opportunity” to tackle obesity and heart disease with junk food taxes — as proposed in an earlier draft of the Safe Hearts Plan. Samuele Tonello, at consumer organization BEUC, said the Safe Hearts Plan “lacks teeth” to better protect consumers from unhealthy foods, and flagged the “urgency of [cardiovascular diseases].”  A MAN ON A MISSION Health Commissioner Olivér Várhelyi has made no secret of his support for industry, and has championed the Commission’s competitiveness mantra since taking office in late 2024. Health Commissioner Olivér Várhelyi has made no secret of his support for industry, and has championed the Commission’s competitiveness mantra since taking office in late 2024. | Thierry Monasse/Getty Images The standout feature of his end-of-year bonanza was the 12-month patent extension in the Biotech Act I — legislation that was split in two late in the day, allowing Várhelyi to meet his end-of-year deadline for the pharma component. The proposal came just a week after the Commission, countries and MEPs clinched a deal to reform Europe’s pharmaceutical laws, in which IP rights were among the last issues to be settled. Updates to the pharma laws were a legacy of the last Commission, whereas the Biotech Act became something of a personal mission for Várhelyi. He repeatedly stressed that there was “no time to lose” in delivering a targeted policy aimed at revitalizing Europe’s flagging biotech industry, which risks being overtaken by competition from China and the U.S. Few commissioners are more vocal than Várhelyi about the premium they place on the competitiveness of European industry.  Industry insiders had heard whispers of his plans to expand IP incentives for the biotech sector, even if Council representatives were dismayed not to have been informed in advance — especially with the ink barely dry on the Pharma Package. That’s not to say pharma is happy with its lot. Industry lobby group the European Federation of Pharmaceutical Industries and Associations (EFPIA) tempered its praise of the Biotech Act, lamenting that the extra year of monopoly rights would only apply to a “limited subset of products.”  The extra year of protection is tied to the Commission’s efforts to locate more pharma research and manufacturing in Europe. It would apply only to new products, tested and at least partially made in Europe.  But the generics sector, which makes cheaper, off-patent drugs to compete with branded medicines, sees the Biotech Act as a further sweetening of what is already one of the world’s most generous IP systems. Lobby group Medicines for Europe claims each year of delayed competition for the top three biologic drugs would cost countries €7.7 billion. Longer IP “will have a dramatic impact on healthcare budgets and delayed patients’ access to essential medicines,” said Adrian van den Hoven, head of the lobby. These kinds of estimates would normally be included in an impact assessment published alongside the proposal, but in its haste to get the Biotech Act out the Commission didn’t do one. POLITICO asked the Commission for an estimate of what the extra year of patent protection would cost. A Commission spokesperson would not give a figure but said they had used the impact assessment for the pharma legislation as a reference. “It is also important to stress that the number of products eligible for an additional year of SPC will be limited to only those that are truly innovative and tested and manufactured in the EU. The approach is deliberately targeted to incentivise genuinely innovative therapies that deliver a clear added value for patients and support European innovation,” the spokesperson said. LUCKY ESCAPE FOR UPFS The big food and drink sectors are on shakier ground with Várhelyi. The commissioner has repeatedly made known his distaste for ultra-processed food, and an early leaked version of the Safe Hearts Plan included new taxes on unhealthy highly processed foods and alcopops. But the final proposal showed the Commission had undertaken a significant climbdown. Concrete targets to tax unhealthy food and drink in 2026 were gone, replaced with a much woollier commitment to “work towards” such a levy. Alcopops were excluded altogether.  Industry lobby FoodDrinkEurope took a far more measured tone on the final plan than its explosive reactions to the earlier leaks, but that may well ramp up again if and when health tax proposals emerge. The text suggests the soft drinks industry may be the Commission’s first target if it does decide to pursue new levies, while UPFs remain in Várhelyi’s sights. “In the next couple of years, we will need to tackle the issue of ultra-processed food much more,” he told MEPs in December. For now, though, the plan seems to have let industry off easy. Health NGOs saw it as a disappointment, given its lack of hard-hitting policies to reduce consumption of UPFs and other unhealthy products. While the pharma legislation is all wrapped up, the Biotech Act still needs to win the approval of EU countries and the European Parliament. For the food and pharma sectors, the proposals set out this month are confirmation they have allies in the Berlaymont.
Agriculture and Food
Health Care
Medicines
Competitiveness
Intellectual property
EU legislators strike pharmaceutical deal
BRUSSELS — EU lawmakers have clinched a long-awaited agreement on the bloc’s overhaul of its two decades-old pharmaceutical rules — one of the EU’s biggest health files. The revamp is designed to restore Europe’s competitive edge and give companies more certainty that the EU remains an attractive market, while also pushing for more equal access to medicines across member countries. The deal between the Parliament and the Council was struck at 5 a.m. on Thursday, more than two years after the Commission tabled the proposal, which consists of directive and regulation, in spring 2023.  It marks a major victory for the Danish presidency, which pledged to wrap up the file before the end of the year, and for Health Commissioner Olivér Várhelyi, who has pushed to seal the reform amid growing geopolitical uncertainty.
Regulation
Health Care
Medicines
Pharma
Drug and device safety
Pharma lobby blasts Oct. 1 Trump tariff threat
Europe’s pharmaceutical lobby group has criticized Donald Trump’s decision to impose up to 100 percent tariff on drugs coming from overseas, calling it the “worst of all worlds.” But it’s not clear what rate products from the EU would face. The U.S. president announced Thursday evening that brand-name or patented pharmaceutical products will be subject to tariffs from Oct. 1 — unless a drugmaker is building a manufacturing plant in the United States. “‘IS BUILDING’ will be defined as, ‘breaking ground’ and/or ‘under construction.’ There will, therefore, be no Tariff on these Pharmaceutical Products if construction has started,” Trump wrote on Truth Social. “Tariffs increase costs, disrupt supply chains and prevent patients from getting life-saving treatments,” said Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), whose members include Novo Nordisk, Pfizer and AstraZeneca. Products from the EU should in theory only be subject to a maximum 15 percent tariff, after the European Commission negotiated a knocked-down rate in its deal with Washington in July. Trump’s latest post raises questions about how binding the EU-U.S. trade deal is, which limits branded medicines’ tariffs. The deal agreed in July between the pair also sees cheaper generic medicines exempt from the tariffs. Olof Gill, deputy chief spokesperson for the European Commission said the EU does not expect its industry to pay more than 15 percent. “This clear all-inclusive 15% tariff ceiling for EU exports represents an insurance policy that no higher tariffs will emerge for European economic operators,” Gill said. “The EU is the only trade partner to achieve this outcome with the US.” Ireland’s Trade Minister Simon Harris said the EU-U.S. trade deal made it “absolutely clear” that a tariff applied to branded drugs from the EU would be capped at 15 percent. The post also raises the question about whether the United States could tariff individual companies in the same sector at different rates. Although the Trump administration has signaled time and again that it doesn’t pay much heed to rules-based trade, governments can’t simply slap a higher “regular” tariff on one foreign company and a lower one on another under World Trade Organization rules. Duties are usually applied uniformly to all exporters from a given country, or target a specific product altogether — such as steel or medicines — in case of dumping or unfair subsidies. Moll said that “tariffs on medicines, however excessive, would create the worst of all worlds.” She urged Brussels to reopen negotiations with Washington, saying they should discuss “how the EU can improve its support towards the cost of global research and development in a way that doesn’t harm patients in the EU and the US.” “The EU and US continue engaging towards implementing the Joint Statement commitments, while exploring further areas for tariff exemptions as well as wider cooperation,” Gill said. Earlier this week, an official from the Commission’s DG TRADE also said that the EU would continue to push for exemptions to the U.S. tariffs for pharmaceutical and medtech products. Several companies have already said they will increase investment by building new plants in the U.S. in recent months, with Johnson & Johnson and Eli Lilly among those all committing to spend in the country. The story has been updated with Ireland’s position.
Tariffs
Trade
Trade Agreements
Trade UK
Health Care