(ANSA) – BRUSSELS, APRIL 26 – A shorter period of exclusivity on medicines, from the current 10 years to 8, but with the possibility for Pharma to extend the period up to 12 years if they undertake to guarantee access to the new ones medicines in all Member States or to address unmet medical needs. This is the main innovation contained in the sector reform package presented today by the European Commission, which aims to expand access to medicines at affordable prices.
Among the proposed measures, also the faster entry into the market for generic drugs, from the day of expiry of the exclusivity period.
The EU launches the electronic leaflet of medicines
To provide patients with accurate information in their own language
In addition to the classic leaflet, the European Commission is proposing to set up an electronic leaflet, to guarantee accurate information to patients in their own language. This was announced by the vice president of the EU executive, Margaritis Schinas, and the EU commissioner for health, Stella Kyriakides, when presenting the drug reform package. The entire EU plan provides for the digitization of all information on medicines, including on the side of the manufacturer and authorization procedures.
With online information, patients and healthcare providers will be able to access the most up-to-date data on medicines and it is expected to reduce paperwork for drug development professionals, including generics companies. With the digitalisation of applications, the European Medicines Agency will have 180 days for authorization instead of the current 210, while the Commission will have 46 days instead of 67. For medicines of overriding public interest, the EMA will have to take 150 days to review electronic applications and leaflets. The digitization of information will also be essential to reduce the risk of medicine shortages, stresses Brussels, explaining that creating an electronic monitoring system will make it easier to redirect stocks to countries that need them.
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