Reform of EU Pharmaceutical Legislation

The European Commission has published proposals (1) for a new Directive and Regulation, which are due to replace the existing pharmaceutical legislation, i.e. Regulation (EC) No 726/2004 and Directive 2001/83/EC.

Largest reform in over 20 years…

This is presented (2) as the largest reform in over 20 years to make medicines more available, accessible and affordable (3). It is also intended to promote innovation and competitiveness while protecting the environment better.

As described in the Q&A document (4) published by the EU Commission, the proposals will now be discussed by the EU Parliament and Council and no timeline for implementation is provided at this stage.

Impact on Pharmacovigilance..

A side-by-side comparison of the proposals with the existing legislation shows that the impact on Pharmacovigilance obligations is limited. The sections of the Regulation and Directive covering Pharmacovigilance include relatively minor edits and the most significant changes are:

• The proposed Regulation does not contain any reference to the list of medicinal products subject to additional monitoring, suggesting that the “Black Triangle” scheme will be abandoned.
• The proposed Regulation specifies that “in justified cases”, EudraVigilance should contain the Adverse Event Reports associated to products under compassionate use or early access schemes.

The proposals include a reduction of the existing market exclusivity period by 2 years (5). The EFPIA (European Federation of Pharmaceutical Industries and Associations) reacted strongly (6) to the patent package proposal (7) whereas representatives of the generics manufacturers (Medicines for Europe) adopted a more positive tone (8).

“EU pharma-legislation risks sabotaging Europe’s life science industry
putting European patients further away
from the cutting-edge of healthcare”
EFPIA Response to the publication of the EU pharma legislation

Besides this bone of contention, the proposals also refer to the use of electronic product information, and simplify EMA’s structure to two main committees: the CHMP (Committee for Human Medicinal Products) and PRAC (Pharmacovigilance Risk Assessment Committee), whereas the orphan, pediatric and ATMP (Advanced Therapy Medicinal Products) committees would be discontinued.

In addition, an inspectorate would be established within the EMA to reinforce Member States’ capacities, in particular for inspections in third countries.