Long-anticipated European Commission proposals to reform the European Union’s pharmaceutical legislation – the biggest shake-up in 20 years – were finally made public on Wednesday.

The reforms are aimed particularly at addressing access and price disparities between European states, ensuring that all EU citizens have access to the same products at the same price, EU Health Commissioner Stella Kyriakides told a media briefing.

“We are putting forward proposals to ensure that medicines reach patients everywhere in Europe, in a timely and equitable fashion,” said Kyriakides.

Aside from high prices and medicine shortages, the Commission is particularly concerned about “unmet medical needs, rare diseases and antimicrobial resistance (AMR)”. 

The proposals have six policy objectives, namely to:

• create a single market for medicines, thus ensuring that all patients across the EU have “timely and equitable access to safe, effective, and affordable medicines”;
• offer “an attractive and innovation-friendly framework” for research, development, and production of medicines in Europe;
• speed up procedures significantly, particularly by reducing authorisation times for medicines to 180 days, so they reach patients faster;
• enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU;
• address antimicrobial resistance (AMR) and pharmaceuticals in the environment through a One Health approach;
• Make medicines more environmentally sustainable.

We want medicine to be more accessible, available, and affordable.

Our #EUPharmaStrategy legislative reform proposes a single market of medicines that:

🔸 is patient-centric
🔹 fosters innovation
🔸 fights antimicrobial resistance
🔹 is environmentally friendly ↓#HealthUnion

— European Commission (@EU_Commission) April 26, 2023

One of its proposals involves cutting drug market exclusivity for new medicines from 10 to eight years, after which the market will be opened to generics.

However, drug companies that launch new medicines in all 27 EU member states within two years of development will still be able to get the extra two years’ exclusivity. In addition, manufacturers producing treatments for “unmet medical needs” will get an extra six months of protection.

As an incentive to manufacturers to develop new antibiotics, the EC proposes  “transferable exclusivity vouchers (TEVs)” for drug companies that give a year of protection to any of the company’s medicines.

The proposals also envisage the EU being able to set up manufacturing of vaccines and drugs using compulsory licenses during public health emergencies.

Positive precedent, says MSF

Dimitri Eynikel, EU Policy Advisor for Médecins Sans Frontières (MSF) Access Campaign, said that “with some tweaks”, the reforms “could set a positive precedent towards enshrining access to medicines provisions in law”. 

“We applaud the proposal’s bid for greater transparency: obliging companies to open their books on all direct public funding received for the research and development of medicines is a critical step to ensure that medicines are priced appropriately and affordably for the people who need them,” said Eynikel.

“In addition, plans for granting more effective compulsory licenses by suspending data and market exclusivity would be historic, and should encourage other countries and regions to adopt similar measures to secure the availability of affordable medicines.”

But MSF is against the introduction of vouchers to encourage the development of new antimicrobials, warning that this could “prolong pharmaceutical monopolies, undermine generic competition and severely slow down people’s access to new and affordable medicines”. 

Pharma unhappy

However, the reaction from pharmaceutical companies has been less positive. The European Federation of Pharmaceutical Industries and Associations (EFPIA) says that the proposals will “undermine research and development in Europe while failing to address access to medicines for patients.”

EFPIA Director General Nathalie Moll laid the blame for slow access to medicines at the door of different systems in EU member states: “Fixing the tenfold variation in access to new medicines across the EU, requires all partners to urgently get round the table and address the real issues rather than unworkable EU-level legislation that is destined to fail.”

“Although the revised legislation was meant to improve Europe’s competitiveness, the ‘net’ impact of policies set out across these proposals, in their current form, puts European competitiveness at risk,’ said EFPIA president Hubertus von Baumbach.

Meanwhile, GSK Chief Executive Emma Walmsley told Reuters that weakening market exclusivity protections “could discourage companies from researching and launching treatments in Europe”.

Process

The European Parliament still has to pass the proposals, which means that there are still a number of opportunities for the proposals to be tweaked or changed.

However, MSF’s Eynikel appealed to EU member states and the European Parliament not to water down the provisions on transparency and compulsory licenses.