Drug makers say European patients miss out on four in ten new medicines. The OECD says about half of new medicines work no better than what patients already get. Who is right will shape what Europe pays for and which cures reach its patients.

The chairs of nine pharmaceutical companies told Europe’s leaders on 22 September that the continent “does not value” innovation, pointing to the roughly 40 per cent of newly approved medicines that never reach European patients. The same day, the Organisation for Economic Co-operation and Development (OECD) read the same gap differently. More than half of the new medicines and indications France has assessed since 2010 showed no added benefit over existing care. Germany reaches the same verdict for roughly half.

Federico Pratellesi of the OECD presented the figures at a State of Health in the EU webinar organised by the European Observatory on Health Systems and Policies. The session built on the medicines chapters of the Observatory’s Synthesis Report 2025. The new EU pharmaceutical law, which ties rewards to added benefit, now has a date too. The final texts of its regulation and directive are public ahead of the formal votes in the Council of the EU and the European Parliament. Moritz Suppliet of the European Commission’s health department told the same session that the aim is to publish both in the Official Journal in November, with entry into force in December.

One medicine in two, and 578 days

“In early 2025, only one in two medicines approved in recent years were available to patients,” said Nicole Mauer, a lead author of the report at the Observatory. The wait from EU approval to reimbursement averaged 578 days and passed 800 days in Portugal, Romania, and Lithuania. Availability ranged from 90 per cent of new medicines in Germany to 10 per cent in Malta.

Mr Pratellesi took the same figures and asked what they count. “When we talk about access to new medicines, access to what exactly? Because new medicines differ enormously in how much they add for patients,” he said.

The access indicators count medicines and count dates. “A medicine that potentially transforms the life of a child with a rare disease counts as one. And also a medicine that works about as well as the incumbent treatment also counts as one,” Mr Pratellesi said. “So when we read that a country reimburses 46 per cent of new medicines, we do not know whether it is missing the ones that matter most to patients or the ones that matter least.”

Health technology assessment (HTA) bodies exist to answer that question. The European Medicines Agency (EMA) decides whether a medicine works and is safe enough to sell. HTA bodies ask how much better it is than the treatment patients already receive. In France, the national health authority, the Haute Autorité de Santé (HAS), grades every new medicine on a five-level scale, from major added benefit (ASMR I) to none (ASMR V), and publishes the results every year.

No added benefit

The OECD compiled 15 years of HAS ratings, almost 1,500 assessments of new medicines and new indications from 2010 to 2024. In 56 per cent of cases, HAS found no added benefit over existing care. HAS rated a further 28 per cent as minor. About one in six was a moderate, important, or major advance. In 2024 the no-benefit share reached 60 per cent. “In every single year, no added benefit is the largest group,” Mr Pratellesi said.

New indications, the uses a company adds after first approval, score lower still. Citing a study in the BMJ, Mr Pratellesi said HTA bodies in Europe rated about half of first indications as high value, against 36 per cent of later ones. The EMA approved 215 later indications against 88 first ones among the medicines studied. “The list of things that countries have to assess and negotiate and pay for is getting longer, mainly through additions that are less often of high value,” he said.

Low rating, standard care

A low rating is not a verdict that a medicine is useless. “It just means that it was not shown to work better than what we already have,” Mr Pratellesi said. The grade depends on what came before.

He gave the opposite example of cystic fibrosis and spinal muscular atrophy. “In cystic fibrosis and spinal muscular atrophy there was no treatment acting on the disease itself. The new medicines changed that. With one exception, France rated them as either moderate or important advances,” he said.

The new blood thinners arrived when warfarin already worked and cost very little. HAS rated every one of them as minor or of no added benefit. They are now standard care in every country the OECD examined, he said, “because they do not need the regular blood tests and those adjustments that warfarin does”. The rating “tells the payer basically how hard they should be negotiating”.

Slow payers, hard bargains

If the rating is a negotiating signal, slow reimbursement is not always a failure. Mr Pratellesi drew three conclusions. First, measure access by added benefit. “If a country is slow to reimburse a major advance, that’s a real access problem. But if it is slow to reimburse a medicine with no added benefit, that may simply be a payer negotiating hard, which in a way we can consider that it’s its job. Today, the indicator cannot tell the two apart,” he said.

If it is slow to reimburse a medicine with no added benefit, that may simply be a payer negotiating hard. — Federico Pratellesi, OECD

Second, put fast pathways and dedicated funds “where benefit is demonstrated” and “stay firm on price for the rest”. Italy reserves its fund for innovative medicines for those that pass a test of added value, he noted. Third, build on the EU Health Technology Assessment Regulation. Since January 2025, new cancer medicines and advanced therapies go through one joint clinical assessment at EU level. By 2030 that will cover all new medicines. Judging how much benefit the evidence shows, and setting the price, remain national decisions.

Ms Mauer said the joint assessments will matter most for countries with the least capacity. “Smaller countries may not be able to do the same types of assessments that larger countries with very well established HTA bodies and governance have,” she said.

Late launch

Asked why reimbursement takes so long, Mr Pratellesi put company behaviour first. Many countries set their prices by reference to prices in other countries. “Firms launch late or sometimes not at all in smaller and lower priced markets, partly to protect the reference prices elsewhere. So a sizeable share of the delay in these countries happens before any national process even kickstarts,” he said.

Then come national processes and the evidence itself. “We have more medicines that are single arm or conditional data. So payers spend literally a longer amount of time negotiating this uncertainty. And that’s not always bad,” he added.

He acknowledged the limits of his own argument. “For smaller and lower income countries, the main obstacles are ability to pay and the order in which companies choose to launch,” he said. “Looking at access through added value does not really remove these obstacles. But what it does show is where the gaps hurt patients most.”

Nine years for everyone, twelve for the best

The new EU pharmaceutical legislation “applies the same logic upstream,” Mr Pratellesi said. Mr Suppliet described the new incentives. “There’s an incentive system that’s not one incentive system for all, but that provides really incentives to bring medicines for unmet medical needs with significant clinical benefits to European patients,” he said.

Every new medicine gets eight years of regulatory data protection plus one year of market protection, “so nine years for everyone,” Mr Suppliet said. Developers can add a year if the medicine addresses an unmet medical need, a year if the dossier contains a comparative clinical trial run in Europe or the company filed the application early with the EMA, and a year for a new indication of significant clinical benefit. The ceiling is 12 years.

These are regulatory protection periods, not intellectual property rights. “It’s a different thing from intellectual property rights,” Mr Suppliet said. Comparative trials are “basically the evidence that HTA bodies require”, Mr Pratellesi noted.

“None of the legal texts has yet been adopted,” Mr Suppliet cautioned. “Now, in September, October, last small changes are voted on in Council and in the European Parliament,” he said. A Commission slide shown at the webinar puts the Parliament’s second-reading vote at the 19–22 October plenary.

Pushback: boardrooms and Washington

The argument for paying by benefit landed on a day when the pressure ran the other way. The chairs of AstraZeneca, Boehringer Ingelheim, Chiesi, Ipsen, GSK, Novo Nordisk, Novartis, Roche, and Sanofi published their open letter to national leaders. It says Europe has spent decades treating medicines “as a cost to suppress rather than one of the best investments a government can make”. It puts the share of newly approved therapies that never reach European patients at around 40 per cent, with the rest waiting nearly 600 days.

The chairs point to Europe’s shrinking weight in global pharma. Its share of research and development fell from 43 per cent in 1990 to 31 per cent. Its share of clinical trials halved in a decade, to nine per cent. Meanwhile, companies announced over $600bn of investment in the US and China in just two years.

Bigger budgets or firmer prices

The chairs ask for bigger health budgets, faster assessment and funding, EU fiscal flexibility for countries that spend on medicines, and “modernised value frameworks” reflecting “the total value” of a treatment to patients, health systems, and the economy. Yet Germany already reimburses 90 per cent of new medicines and, like France, rates them on added benefit.

On the same day, the Office of the US Trade Representative (USTR) held a public hearing in its investigation into Germany’s “persistent underpayment for innovative pharmaceutical products”. USTR opened the probe on 18 June under Section 301, a US trade law that allows tariffs. USTR says US consumers pay about 3.9 times German prices for brand-name drugs. A finding against Germany could bring tariffs or other trade restrictions. Webinar participants called the US pressure “the elephant in the room”. “It is exceedingly frustrating that we don’t really know exactly what shape the elephant in the room takes,” said moderator Dimitra Panteli of the Observatory.

Today the money follows where trials are, let’s be honest, easiest and prices highest. — Federico Pratellesi, OECD

Mr Pratellesi’s proposal points the other way: fast pathways and funding where the benefit is demonstrated, and firm prices for the rest. “We already shape it with what we pay for,” he said of innovation. “Today the money follows where trials are, let’s be honest, easiest and prices highest, which is partly also why we see crowded oncology indications and little in the area of antibiotics.” “If access and reward were reported by this idea of added benefit, I think the signal to industry would be much, much cleaner,” he added.

Benefit over volume

Europe’s access debate has run on one number: how many new medicines reach patients, and how fast. The chairs’ letter reads it as proof that Europe undervalues innovation. The OECD says the same number hides that about half of what arrives brings no added benefit over existing care.

The pharma package, expected to enter into force in December, and the joint clinical assessments due to cover all new medicines by 2030 both move the measure towards benefit rather than volume. An OECD report on therapeutic value will follow “in the coming month or two”, Mr Pratellesi said.