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. 
Health Care
Health systems
Global health
Pharma
Doctors
Big Pharma is using tariffs to hold Europe to ransom
Nick Dearden is the director of Global Justice Now. Peter Maybarduk is the Access to Medicines director of Public Citizen. Both are members of the People’s Medicines Alliance. U.S. President Donald Trump has more tariff chaos up his sleeve, and medicine in his sights. This week, he issued an executive order blaming America’s sky-high drug prices on other countries — and pharmaceutical tariffs could be next.  Panic is starting to set in. Tens of thousands of pharmaceutical workers in Ireland are worried about their jobs; politicians across the EU and U.K. are concerned the industry will pull investment and reinvest across the Atlantic; and there are even warnings of higher prices and drug shortages — particularly for generic medicines — in the U.S. But it is the pharmaceutical industry itself that’s stoking these fears. Big Pharma corporations never miss a chance to turn crisis into opportunity and to boost their already inflated profits. And now, they’re using the opening Trump has given them to demand the removal of regulations they dislike. Under the pretense that Europe is no longer a profitable place to invest and manufacture, drug makers are demanding all manner of concessions, including looser regulation on clinical trials and tighter monopoly protection of the intellectual property that underpins their power. Most of these have nothing to do with making Europe a better place to manufacture drugs and everything to do with raising prices. And it should make us very suspicious of lobby group claims that “unless Europe delivers rapid, radical policy change then pharmaceutical research, development and manufacturing is increasingly likely to be directed towards the US.” Since Trump has Big Pharma’s back, we can surely expect he’ll push their wishlist — yet another reason governments have to reject his attempts to strong-arm them. Meanwhile, a similar move is afoot in the U.K., with pharma companies pushing the government to reform the system that helps the National Health Service keep a lid on medicine costs. The government has already granted them a review. None of this should surprise us. Why wouldn’t Big Pharma latch on to the opportunity of Trump’s tariff threats to make price-gouging easier, even if it’s one of the most profitable industries in the world already? The truth is, it’s perfectly profitable to produce medicines in Europe as is — it just isn’t profitable enough for an industry that feels entitled to sky-high returns. According to the pharmaceutical industry, it must secure these returns to invest in a new generation of medicines, the cost of which is high. But sadly, even handing blank checks to Big Pharma wouldn’t get us the medicines we need at a price we can afford. Instead, it just means “unprofitable” but potentially devastating problems like antimicrobial resistance will be ignored, while companies try to create the next blockbuster drug that our health services won’t be able to afford. Big Pharma is a bully. It will take what it can get and then come back for more. This isn’t to say Trump’s tariffs wouldn’t create havoc in supply chains and hit generic production where margins are low. Indeed, generic manufacturers are warning that any increase in production costs could lead to drug shortages and higher prices — including for U.S. patients. Generic manufacturers are warning that any increase in production costs could lead to drug shortages and higher prices — including for U.S. patients. | Allison Dinner/EFE via EPA But European governments need to take this as an opportunity for restructuring how they make medicines, and create a model that serves the public interest. Of course, this will cost money. But medicines cost the public a small fortune anyway. And if we’re going to be spending, let’s at least ensure we’re getting the medicines we want and aren’t paying twice for the final product. What we need is to work across Europe to build world-class, publicly controlled medical research capacity. Then, rather than handing over that research — or, indeed, the patient data underlying it — to the pharma cartel, we need to develop a different model of intellectual property protection that allows for the sharing and licensing of research in a way that supports international collaboration to produce better medicines for all. Such an approach wouldn’t just undercut Trump’s plans to enhance U.S. power, it would also mean no longer treating lifesaving medical knowledge as commercial property that only the richest can afford. Knowledge is the lifeblood of modern society, we are told — so, why are we allowing private interests to wall it off for decades? In the meantime, we need to build manufacturing capacity as well. The public sector doesn’t have to produce every medicine our society needs, but in an increasingly insecure world, we do need more homegrown capacity. That means a more balanced range of private sector companies involved in medicines, as well as better public sector capacity, so we can’t be held to ransom. Finally, given the long-term impact that cuts to U.S. and European aid will have on health care globally, we should work with countries in the global south to help boost their production capacity too. As things stand, too many nations have been discouraged from addressing their local health needs. And we should be supporting them with our know-how, technology transfer and a different intellectual property model. We can have a world where everyone has access to the medicines they need. But both Trump and Big Pharma will push us in the opposite direction. It’s time for something else.
Donald Trump
Medicines
Research and Development
Opinion
Regulation
Trump says pharma tariffs will entice back drug production. They won’t.
BRUSSELS — After hitting just about every other industry he can think of (albeit with a brief pause), Donald Trump’s long-promised tariffs on drugs are around the corner. “We’re going to be announcing very shortly a major tariff on pharmaceuticals,” he said at a dinner of the National Republican Congressional Committee last week. “And when they hear that, they will leave China. They will leave other places because they have to sell — most of their product is sold here and they’re going to be opening up their plants all over the place.” Are they, though?  It’s true that the branded pharmaceuticals — the household names that left the U.S. for Ireland and its favorable tax regime — need a continued presence in the U.S. because it’s such a big market for pharma, and due to its “relatively short time-to-market for innovative medication,” according to analysts at ING. “Given their presence all over the globe and their higher margins, some shuffling in their supply chains as a result of tariffs is likely,” they wrote in a briefing. But will it lead to the full-scale exodus that Trump has promised? In 2024, pharmaceuticals were the EU’s largest export to the U.S., worth a reported $127 billion. “You don’t move manufacturing overnight,” said Justine Fassion, an international trade lawyer at Sidley.  “Manufacturing in the pharma industry is subject to various regulatory constraints, so it can take time before you can move production from one country to another,” she said in an interview with POLITICO earlier this year. Building a manufacturing plant from the ground up generally takes three to five years, much of it related to the local permitting process for utilities, disposal and other community concerns, according to Marta Wosińska, a senior fellow at the Brookings Institute. “What makes local permits challenging is that they can vary dramatically across locations, increasing the risk for potential delays,” she noted in a briefing. It’s also extremely costly. Recent infrastructure expansions in the United States by big-name pharmaceuticals have been led by Eli Lilly’s $23 billion investment into multiple facilities. Merck recently opened a $1 billion plant in North Carolina, where Novo Nordisk is also undertaking a $4.1 billion fill and finish expansion. And Johnson & Johnson is ploughing $2 billion into a biologics facility in New Jersey. But the cost of site construction might rise further because of the 25 percent tariff Trump has imposed on steel, a major input in industrial construction, she added. “The same concern applies to manufacturing equipment, which is all stainless steel,” she wrote. The largest pharma companies warned through their European industry association, EFPIA, that pharma research, development and manufacturing is likely to be redirected toward the U.S., when they sat down for crisis talks with European Commission President Ursula von der Leyen this week. But the group — conscious that interinstitutional negotiations are about to begin on a Brussels plan to overhaul landmark EU pharma legislation, and the industry’s existing lucrative patent protection with it — added that the migration could be put on hold if Europe “delivers rapid, radical policy change.” That would mean “strengthening rather than weakening Europe’s intellectual property provisions,” the group said in an emailed statement, as well as “achieving a competitive EU market that attracts, values and rewards innovation in line with other economies at the forefront of patient care.” Alexander Natz, secretary-general of Eucope, which represents mid-sized pharma companies, said: “Many of our members don’t have factories in the U.S. We can’t just build … within two months, factories in the U.S.” Smaller and medium-sized pharma companies tend to have one or two innovative products, he said, and they “don’t have a product portfolio to say, ‘well, OK, I can level out the impact of the tariffs on product A, which is produced in that territory, by increasing sales potentially in product B.” The larger companies that Trump is hoping to entice back might also not think it’s worth the bother. “These tariffs might not be around forever,” said Jeremy Leonard, managing director of industry services at Oxford Economics. “It may actually be in your interest to suck up the tariffs and just ride out the storm,” he said, arguing that those companies might instead choose to reduce investments in research and development rather than switch production. “There certainly are some companies who will do that calculus,” he said. “I don’t think it’s necessarily going to mean a sort of tidal wave of movement, quite frankly.” What actually encourages companies to move — as Trump alluded to when he called out Dublin — isn’t tariffs, said Ned Hux, a pharmaceutical and life sciences tax partner at PwC.  “Targeted tax incentives, streamlined regulatory approvals, and prioritized government procurement could make U.S.-based production more attractive and competitive,” he said, adding those measures could come in the form of tax deductions, lower tax rates on manufacturing activity, tax credits and low-interest financing for domestic production.  “These approaches offer a proactive way to strengthen U.S. pharmaceutical independence without disrupting global trade relationships,” he added. And while Trump has criticized Ireland for attracting big pharma companies, he’s also suggested he wants to reshore production of generic drugs from India and China, with an eye to making medicines cheaper for Americans. ING warns, however, that production in the U.S. would lead to higher prices, as U.S. labor and production costs are higher than those in India, for instance. Generics lobby Medicines for Europe says that its own analysis of API (active pharmaceutical ingredient) supplier locations for the U.S. market demonstrated that for almost 700 APIs approved in the U.S., Europe is the only supplier. “The U.S. alone will struggle to build competitive manufacturing and strategic autonomy,” said its director general, Adrian van den Hoven.  “The knock on effect of tariffs will be to drive up costs even higher for American patients.” Giedre Peseckyte contributed to this report.
Health Care
Manufacturing
Tariffs
Trade
Pharma