European Parliament committee proposes changes to pharma legislation

The European Parliament’s health committee is set to debate and vote on changes to the proposed pharmaceutical legislation on 19 March, including provisions that would increase market exclusivity and regulatory data protection compared to the European Commission’s proposal released last year.

Ahead of the debate, the Parliament's Committee on Environment, Public Health and Food Safety (ENVI) has published compromise amendments to the European Commission’s proposed revisions to the existing directive its proposal for a new regulation. The amendments include suggested changes by the ENVI representatives leading the process and other members of the committee.

The proposal for a new regulation contains some of the changes that have received pushback from the branded pharma industry, such as planned changes to market exclusivity terms. Currently, the European Union provides eight years of data protection followed by two years of marketing protection. The Commission has proposed reducing data protection to six years and giving companies the chance to extend the period through actions such as launching their drugs in all EU countries.

Market exclusivity

While the European Commission had proposed reducing the period of regulatory data protection for new medicines from eight years under the existing legislation to six years, the ENVI committee’s compromise would instead give drugmakers 7.5 years of regulatory data protection, with an additional periods of protection if the product address unmet medical needs or if clinical trials were conducted within the EU.

The compromise amendments would retain the European Commission’s nine-year exclusivity period for orphan medicinal products, whereas an earlier push by the regulation’s rapporteur Tiemo Wölken would have reduced the period to eight years, and increase the exclusivity period to 11 years if the product addresses a high unmet medical need. Additionally, the compromise amendments would reduce market exclusivity for orphan products authorized under so-called bibliographic applications from five years under the Commission proposal to four years.

The Commission has received little pushback from ENVI members on its plans to reduce the time EMA takes to perform scientific evaluations of drug filings from 210 days to 180 days, and the Commission’s proposed 180-day period is retained in the compromise amendments.

Next steps

ENVI members will meet to discuss and vote on the amendments to the draft regulation, as well as the revisions to the existing directive, on 19 March. The vote is another important moment in the creation of the new pharmaceutical framework. While multiple committees will offer opinions on the Commission’s proposal, ENVI is the parliamentary group responsible for the legislation.

The committee has been working to establish its position on the legislation in parallel to the European Council’s assessment of the proposals. The talks and votes will inform planned negotiations between the three main EU bodies. The Commission’s term of office runs until 31 October 2024, raising doubts about whether policymakers can complete the process before the end of the current mandate.

Meeting schedule

European Parliament committee proposes changes to pharma legislation

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