Pharma industry calls EU pharma package counterproductive
Pharmaceutical associations have responded with sharp criticism to the adoption of the revised general pharmaceutical legislation by the EU Council of Ministers in the form of a directive and a regulation. They argue that the measures are not suitable for bringing Europe back to the forefront of pharmaceutical research and will make the EU an unattractive location for investment.
The criticism from the EU pharmaceutical association EFPIA and the German VFA is directed primarily at the restriction of property rights for pharmaceutical innovations, in particular for orphan drugs, which currently enjoy 20 years of patent protection plus a five-year supplementary protection certificate (SPC) and up to 11 years of data exclusivity protection (8 + 2 + 1) after approval.
The pharmaceutical industry lobby groups criticise the reduction of data exclusivity protection, which protects original preparations from competition from cheaper generics and biosimilars, from eight to six years in order to enable better care even in resource-poor health systems, as an experiment at the wrong time and in the wrong place. Under the new regulatory proposals, around one-third of medicines would be protected from copies and biosimilar competition for a shorter period of time.
While China and the US are sending clear signals to drug innovators, the EU would forfeit its claim to leadership with this draft. Planned changes to market authorisation (simultaneously in all EU countries), the obligation to conduct comparative clinical trials and the permission to conduct investigator-driven clinical trials for indication expansion in areas with high unmet medical needs without the consent of the drug developer also make pharmaceutical lobbyists fear for future sales. The vfa is threatening the EU that this would lead to companies leaving in the long term.
However, the question of US President Donald Trump’s threatened 80% price cuts in the world’s most expensive market, the US, makes this threat ring hollow. Last year, large pharmaceutical companies generated around 44% of their sales in the US, 20% in the EU and 7% in China. Nevertheless, the EFPIA claims: ‘The decision to reduce intellectual property protection for pharmaceutical companies makes Europe less attractive, deters investment and jeopardises the development of innovative therapies in Europe without removing the underlying barriers and delays in access for patients.’ Vfa President Han Steutel goes one step further: ‘If you want innovation, you have to enable investment,’ he said. He also said that the six-month advance notice period for supply shortages provided for in the Medicines Act is too bureaucratic and therefore impractical.
Furthermore, while the introduction of transferable exclusivity vouchers for antibiotics with a novel mechanism of action is a good incentive for the development of new antibiotics, the vfa criticises that the design is so cumbersome that the new instrument remains ineffective. Following the withdrawal of the pharmaceutical industry for reasons of profitability, antibiotic innovations are mainly taking place in biotechnological SMEs. In the context of the upcoming trilogue negotiations, the EU Parliament and the Council of Ministers must make changes to ensure the competitiveness of the EU as a location, the pharmaceutical associations demand.
The EU medicines package is also intended to increase the number of clinical trials conducted in the EU. However, these lag significantly behind the declining figures in the US since 2015 and the rapidly rising figures in China since 2015.
