Revising pharmaceutical legislation

The contest for the best reform proposals reached the European Parliament during the run-up to revising the pharmaceutical legislation.

Countering excessive prices

Back in October, a letter from the Chair of the Committee on Industry, Research and Energy (ITRE) Cristian Silviu Busoi (Christian Democrats/EPP) and other committee members, mainly from the EPP and RENEW/Liberal parties, was circulating in political Brussels. Together they expressed particular concerned about ideas to increase the transparency relating to R&D spending by pharmaceutical manufacturers and making clinical trial data more widely available. Both are central demands of the funding bodies as well as German Social Security. This information is needed in order to arrive at realistic estimates and appropriate prices during reimbursement negotiations and benefit assessments. All of the health systems and the insured must ultimately be protected from excessive drug prices in order to remain functional.

Ensuring that medicines can be supplied in all countries

The European Consumers' Organisation also became involved in the discussion at the beginning of November and they have also addressed the European Parliament. In its letter of 2 November 2022 the European Consumers' Organisation stressed the importance of R&D reaching everyday healthcare. High drug prices, often for cancer therapies, would prevent this. Furthermore, not all of the new medicines would be available in all of the EU’s member states for commercial reasons. This would create inequalities.

Voluntary agreements made by the industry are not enough

The European Consumers' Organisation have said that the existing incentive system must be revised in a balanced way to be part of the new pharmaceutical legislation. In addition to affordable prices, availability of generics and biosimilars must be ensured and it must also be ensured that the new medicines are available in all of the member states. Voluntary agreements by the industry would not be enough.

No to pharmaceutical vouchers

The consumer association is also clearly against the so-called TEE (Transferable Exclusivity Extension) vouchers, which the European Commission still wants to use to promote the development of new antimicrobial drugs. According to the European Consumers' Organisation, the idea that after market exclusivity has been established, the rights can then be transferred to other pharmaceutical products or sold to third parties obstructs generic competition and leads to enormous costs in health systems, e.g. when such rights are transferred to blockbusters from pharmaceutical companies without any further restrictions. Even one year of additional exclusivity protection will lead to higher expenses for health insurers, which could have been avoided if generic competition had started earlier (please see your news from August 2022).

The European Commission proposal to revise pharmaceutical legislation was originally expected in the fourth quarter of this year, but will now be delayed until 2023.