The EU is planning a sweeping revision of its pharma legislation in March, the largest change in 20 years. The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact.

The revision process is reviving old conflicts in the pharma industry over fair and affordable access to medicines versus Europe’s status as a competitive home for pharma innovation.

A leaked draft (see below) of the legislation, whose final version will be published next month, proposes reducing market exclusivity time by one year for most branded drugs, although it would extend exclusivity for certain drugs for unmet needs.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade organisation for branded drugs, said the proposals ‘would irretrievably sabotage’ the EU pharma industry and ‘would send Europe to the back of the queue for healthcare treatments, clinical research, jobs, and global investment’. The draft’s revisions are anti-competitive and will send pharma companies to the US and Asia, said EFPIA Director General Nathalie Moll in a February statement.

But the EU draft document says that the changes will make medicines more affordable, improve unequal access to medicines across the EU, and fulfil unmet patient needs. The changes to the length of drug exclusivity will ‘strike[e] a balance between providing attractive incentives for innovation and supporting timely patient access to medicines across the EU’. Altogether, the revisions would increase access to new medicines by 8%, or 36 million EU citizens, and save €337 million ($357 million) for public payers, the draft predicts.

EU competitiveness

Moll said the legislation revisions should instead be used to make Europe more attractive to pharma companies. Speaking during a webinar titled Even spaceships need a launchpad, addressing the revisions on January 31, she said, “The situation that Europe is facing in general, the economic situation, energy prices, and difficulty with supply. We are not the most attractive location at the moment.” Other regions have incentivised pharmaceutical investment and are ‘attracting clinical trials like crazy’. She continued, stating that “We need to reverse the decline we’ve seen in the past 20 years.”

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But others do not accept that the EU is less competitive for the pharma industry than North America and Asia. “The products that are authorised in EU are largely the same as other regions,” argued European Commission Directorate-General for Health and Food Safety Florian Schmidt, during the same online event. “You can compare timelines. I would claim that the variety offered here is on a par with other regions.” He pointed out that Europe was the first region to approve biosimilars.

Emer Cooke, European Medicines Agency (EMA) executive director, countered that, when comparing drug approvals with other regions’, “Faster isn’t necessarily better. If you measure everything on faster, I’m not sure Europe will always come out ahead.” She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation.

Outdated law

Whatever the outcome, everyone involved agrees that the legislation needs a makeover. “We need to change our regulatory framework, which comes from a very different era,” said European Commissioner for Health and Food Safety Stella Kyriakides in a speech to the EU in December.

European Parliament for Romania member Cristian-Silviu Busoi told the webinar that the legislation is out of date for clinical trials, comparing the EMA’s resources unfavourably with the staffing of China’s NMPA.

The EMA’s Cooke called next month’s legislation ‘a great opportunity in front of us in terms of futureproofing’ that should account for new types of medicine such as CAR T-cells, and the blurring of boundaries between drugs and devices.

Medicines for Europe, the organisation for generics and biosimilars, has called for the new law to encourage the uptake of generics and biosimilars, and tackle the impact of inflation on the security of essential medicine supplies with smart procurement guidelines for medicine.

What’s in the draft?

A leaked October draft published by Politico proposes these policies:

  1. Approved drugs must launch in all EU countries within two years
  2. A shorter regulatory data protection (RDP) period- the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation
  3. An extra year of RDP for drugs meeting an unmet need
  4. For rare disease drugs, a variable RDP period of five, nine, or ten years, depending on the novelty of the drug
  5. An extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care)
  6. A voucher system to encourage antibiotic development. Vouchers will grant one extra year of RDP, transferable to other drugs or sellable
  7. Stronger obligations for pharma companies to report shortages, and to offer a drug’s marketing authorisation to another company before withdrawing it from the market
  8. Requiring clinical trials in children where a drug is approved in adults for a different disease
  9. Introducing temporary emergency marketing authorisations
  10. Extra foreign inspections
  11. Simplifying drug applications, at a benefit to SMEs

The revisions will replace the current EU pharmaceutical legislation: Directive 2001/83/EC and Regulation (EC) No 726/2004, which cover pharmaceuticals generally, and specific legislation on rare disease therapies (Regulation 141/2000/EC, “Orphan Regulation”), medicines for children (Regulation (EC) 1901/2006, “Paediatric Regulation”), and advanced therapies (Regulation (EC) No 1394/2007, “ATMP Regulation”).