Pharmaceutical Legislation Reform (cepPolicyBrief)
After 20 years, the Commission wants to comprehensively reform the outdated pharmaceutical legislation. The legislative proposals contain numerous delegations of power to the Commission. The Centre for European Policy (cep) considers many of these delegations to be too far-reaching. In particular, the possibility of changing the requirements of an Environmental Risk Assessment (ERA) has far-reaching consequences for the authorisation of medicinal products.
"The Commission's power to change the requirements of the ERA violates the principle that the essential elements of a law are reserved for the EU Parliament and the Council," criticises cep health expert Patrick Stockebrandt, who has analysed the Commission's proposals with cep health expert Nathalja Nolen. This is particularly true in connection with the planned mandatory rejection of the authorisation of a new medicine due to an "insufficient" ERA, as this could hinder patients' access to new, safe and effective medicines, emphasises Nolen.
In addition, the decision on the introduction of electronic-only packaging leaflets will also be transferred to the Commission. "This is a health policy decision that would be better taken by the Member States in a country-specific context," explains Stockebrandt.
In addition, the cep researchers criticise the fact that the period during which the intellectual property of innovative companies is protected is shortened too much. Although this promotes competition through the earlier market entry of generics and biosimilars, it reduces the incentives to bring new medicines on the EU market. In view of the urgent need for new antimicrobials, the planned measures for the development of new antibiotics at EU level are to be welcomed. The proposed one-time transferable voucher for the extension of regulatory data protection is an appropriate means of achieving this, especially as the granting is sensibly restricted in several ways.