The European Commission’s proposal to overhaul pharmaceutical rules could accelerate the decline of innovation in the EU, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The EFPIA says that the proposal would make it more difficult for pharmaceutical companies to develop and bring new drugs to market. The group specifically criticizes the proposal’s plans to reduce the amount of time that companies have exclusive rights to market new drugs, and to allow generic drug manufacturers to enter the market earlier.
The EFPIA says that these changes would make it less profitable for pharmaceutical companies to invest in research and development. The group warns that this could lead to a decline in the number of new drugs being developed, and could make it more difficult for European patients to access the latest treatments.
The European Commission has defended its proposal, saying that it is necessary to make medicines more affordable and accessible to patients. The Commission says that the proposal would also encourage competition and innovation in the pharmaceutical sector.
However, the EFPIA says that the proposal does not take into account the long-term costs of reducing innovation. The group warns that the EU could fall behind other regions in terms of pharmaceutical innovation, and could become reliant on imports from other countries.
The European Commission’s proposal is still in its early stages, and it is unclear whether it will be adopted in its current form. However, the EFPIA’s concerns highlight the potential risks of the proposal, and the importance of striking a balance between affordability and innovation.
Here are some of the key points of the EU proposal:
- Reduce the amount of time that companies have exclusive rights to market new drugs from 10 years to 8 years.
- Allow generic drug manufacturers to enter the market earlier by reducing the data protection period for new drugs from 8 years to 6 years.
- Increase the transparency of clinical trial data.
- Create a new EU Health Technology Assessment (HTA) system to coordinate the assessment of new drugs across the EU.
The EFPIA says that these changes would make it more difficult for pharmaceutical companies to develop and bring new drugs to market, and could lead to a decline in innovation. The European Commission says that the proposal is necessary to make medicines more affordable and accessible to patients, and to encourage competition and innovation in the pharmaceutical sector.
The outcome of this debate will have a significant impact on the future of pharmaceutical innovation in the EU.