Tag - Medicines manufacturing

Ozempic-style drugs should be available to all, not just the rich, says WHO
The World Health Organization has recommended the use of novel weight-loss drugs to curb soaring obesity rates, and urged pharma companies to lower their prices and expand production so that lower-income countries can also benefit. The WHO’s new treatment guideline includes a conditional recommendation to use the so-called GLP-1s — such as Wegovy, Ozempic and Mounjaro — as part of a wider approach that includes healthy diet, exercise and support from doctors. The WHO described its recommendation as “conditional” due to limited data on the long-term efficacy and safety of GLP-1s. The recommendation excludes pregnant women. While GLP-1s are a now well-established treatment in high-income countries, the WHO warns they could reach fewer than 10 percent of people who could benefit by 2030. Among the countries with the highest rates of obesity are those in the Middle East, Latin America and Pacific islands. Meanwhile, Wegovy was only available in around 15 countries as of the start of this year. The WHO wants pharma companies to consider tiered pricing (lower prices in lower-income countries) and voluntary licensing of patents and technology to allow other producers around the word to manufacture GLP-1s, to help expand access to these drugs. Jeremy Farrar, an assistant director general at the WHO, told POLITICO the guidelines would also give an “amber and green light” to generic drugmakers to produce cheaper versions of GLP-1s when the patents expire. Francesca Celletti, a senior adviser on obesity at the WHO, told POLITICO “decisive action” was needed to expand access to GLP-1s, citing the example of antiretroviral HIV drugs earlier this century. “We all thought it was impossible … and then the price went down,” she said.  Key patents on semaglutide, the ingredient in Novo Nordisk’s diabetes and weight-loss drugs Ozempic and Wegovy, will lift in some countries next year, including India, Brazil and China. Indian generics giant Dr. Reddy’s plans to launch a generic semaglutide-based weight-loss drug in 87 countries in 2026, its CEO Erez Israeli said earlier this year, reported Reuters. “U.S. and Europe will open later … (and) all the other Western markets will be open between 2029 to 2033,” Israeli told reporters after the release of quarterly earnings in July. Prices should fall once generics are on the market, but that isn’t the only barrier. Injectable drugs, for example, need cold chain storage. And health systems need to be equipped to roll out the drug once it’s affordable, Celletti said. 
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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.
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