EU’s Pharmaceutical Strategy for Europe / CE revisa Normas

 

As part of the EU’s Pharmaceutical Strategy for Europe, the European Commission has come out with a set of proposals to revise EU pharmaceutical legislation. The reforms, which aim to make medicines more available and accessible across Europe by

 _reducing regulatory exclusivity, 

_speeding up review processes and reinforcing supply chains will also, according to the EC, support innovation and 

_boost the EU pharma industry’s competitiveness. 

 Innovators claim the proposed changes will do just the opposite.

After a number of postponements, the European Commission (EC) at last presented its proposal for the reform of the European bloc’s medicines legislation, its first major overhaul in 20 years. The EC claims that apart from promoting access, the reform will create an environment in Europe for “world-class innovation.” And while generics makers and patient groups applaud the reform, the innovative pharma industry sees it as a hit to the sector’s competitiveness, much like the Inflation Reduction Act in US or the recent tax hikes for UK drugmakers. One of the major issues the new legislation seeks to address is the existing access inequality across Europe with the bloc’s poorer countries normally getting new medicines years after their higher-income counterparts. As an example, Poland and Romania typically wait an average of two years longer to access a new medicines than patients in Germany.

To change this, the proposal puts forth a two-year reduction of the standard 10-year regulatory exclusivity period while introducing incentives for companies to obtain additional competition-free periods. Most importantly, drug makers will be able claim back two years by launching their medicines in all 27 EU markets within two years from the date the marketing authorization is granted. Other ways they can win back competition-free time would be by addressing an unmet medical need, or treating additional disease targets with the same drug.

In innovators’ view, access delays are not a product of favouritism towards richer countries but occur after companies have filed for pricing and reimbursement and are awaiting decisions and the proposed changes will only serve to undermine innovation. “The approach set out in the pharmaceutical legislation, penalizing innovation if a medicine is not available in all member states within two years is fundamentally flawed and represents an impossible target for companies,” said Nathalie Moll, Director General, EFPIA in a release.

For the EUCOPE, the organisation that represents small and mid-sized innovative European pharma companies, the proposal introduces more risk and unpredictability while reducing incentives for innovation and investment. “The Commission’s revision includes troubling proposals … which risk reducing the EU’s global competitiveness in life sciences, thereby limiting the development and availability of innovative therapies,” said EUCOPE Secretary-General Alexander Natz.

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