Members of the European Parliament (MEPs) have voted overwhelmingly in favour of the pharmaceutical reform package following a debate on 10 April.

The vote is a key step in the passage of the new Directive and Regulation, which together form the EU’s revisions to the General Pharmaceutical Legislation (GPL). These revisions are part of the overall EU pharmaceutical strategy that was announced by the European Commission in November 2020, with the core GPL amendments proposals published in April 2023.

With the vote, the European Parliament has now endorsed the position adopted by the Environment, Public Health and Food Safety Committee on 19 March 2024. The Committee had amended the Commission’s proposal in several respects. Overall, the Parliament’s amendments are aimed at encouraging and fostering more innovation in the EU, and industry will be pleased that some of its core concerns have been addressed, although significant areas of uncertainty remain.

The adoption of the package is likely to be delayed by the European Parliament elections in June this year. The reforms will be taken up by the new Parliament after the elections, and so it is difficult to see any agreement being reached before 2026.

Below is a summary of the Parliament’s position in some of the key area. This summary is, however, not exhaustive but rather highlights topics that have been subject to increased interest for industry and extensive discussions in the European Parliament.

Regulatory data protection and unmet medical need

The most significant aspects of the proposals concern protection of pre-clinical and clinical data submitted as part of the marketing authorisation dossier.

Parliament supported a regulatory data protection period of seven and a half years during which generic companies cannot cross-refer to data within the dossier of an innovative product to support the authorisation of a generic/biosimilar/hybrid application, rather than the six years proposed by the Commission.

Under the amendments adopted, additional periods of data protection would be available in certain circumstances:

  • if the product addresses an unmet medical need (see below): 12-month
  • if comparative clinical trials are conducted for the product: six-month
  • if a significant share of the R&D takes place in the EU and at least partly in collaboration with EU research entities: six-month

Under the amendments adopted by the Parliament, the total period of data protection would not exceed eight years and six months.

The data protection period will be in addition to two years of market protection, during which time, as under the current system, generic, hybrid or biosimilar products cannot be placed on the EU market.

The two-year market protection period can be extended by one year if there is an MA for an additional therapeutic indication which provides significant clinical benefits in comparison with existing therapies.

The Parliament did not amend the definition of unmet medical need (UMN) proposed by the Commission, but introduced welcome clarifications in the recitals, in particular that UMN should not influence pricing and reimbursement decisions.

Supply of medicinal products across the EU

One of the biggest areas of controversy under the proposal related to the additional period of data protection that was available for products “released and continuously supplied into the supply chain”.  This would be a significant hurdle that many companies would likely find impossible to overcome, and particularly so for orphan medicinal products.

Important amendments to this proposal have been adopted by the Parliament. In particular, rather than completing a pricing and reimbursement procedure, developers must only file for pricing and reimbursement within 12 months (or 24 months for SMEs, non-for-profit entities and undertakings with less than five EU centralised marketing authorisations) following a request by the EU Member State. Such request must be made by the EU Member State within 1 year of grant of the authorisation or, alternatively, the marketing authorisation holder must be notified that such request may come at a later date. The Parliament’s position also foresees additional flexibilities, including:

  • six months extension of the 12/24 months period
  • alternative timelines agreed with the Member States
  • exemptions for orphan and advance therapy medicinal products, as well as products included in a dedicated list to be developed by the European Commission
  • dispute conciliation mechanisms

Further, where there is a positive pricing and reimbursement decision, the company must ensure appropriate and continued supply of the product to cover the needs of patients in that Member State. Most importantly, this requirement has been delinked from the incentive framework, meaning there is no additional period of protection if this requirement is met. Instead, financial penalties could be imposed.

Orphan products and high unmet medical need

Orphan product exclusivity has also been a much-debated topic. Under the amendments adopted by the Parliament, the standard orphan drug exclusivity would be 9 years, but could be extended to 11 years if the product addresses “high unmet medical need” (HUMN). The Parliament did not make major amendments to the HUMN definition proposed by the European Commission, but clarified that an orphan medicinal product that is the first to be authorised for a given disease will automatically be considered as addressing a HUMN. In addition, all orphan medicinal products will be automatically eligible for the European Medicines Agency PRIME scheme.

The Parliament also maintains the Commission’s position that separate periods of orphan exclusivity for different orphan designations will no longer be available for the same product. However, orphan drug exclusivity can be extended by a total of 2 years if the product is authorised for a new orphan indication. The maximum period of protection will be 13 years.


The Parliament broadly followed the European Commission’s proposal for more extensive requirements to be imposed on marketing authorisation holders in relation to shortages, including the extended early notification requirements, shortage prevention and mitigations plans, and suspension/discontinuation impact risk assessments. The Parliament, however, also:

  • added an additional requirement for the marketing authorisation holder to explain the reasons for any supply disruptions or suspensions of marketing authorisations
  • reinforced the role of the  Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), patient organisations and healthcare professionals

Other amendments

Some other key amendments that are frequently of interest to clients include:

  • The hospital exemption, whereby manufactures of advanced therapy medicinal products (ATMPs) under a hospital exemption will be subject to authorisation by national competent authorities, has been an area of intense debate. The Parliament has extended the scope of these provisions to include manufacture by pharmacists. There are also provisions that will allow cross-border transfer of such products. However, there are also increased provisions on the evidence on quality, safety and efficacy that will be required.
  • MEPs agreed various measures to promote research into novel antimicrobials and made amendment to the original proposals. For example, transferable data exclusivity voucher for priority antimicrobials has been amended so that the voucher has a variable duration depending on whether the product is for ‘critical’, ‘high’ or ‘medium’ antimicrobials. Further, this extension period cannot be used for products that have already benefitted from the maximum regulatory data protection period.
  • MEPs propose to require companies to submit an environmental risk assessment when requesting an MA with an ad-hoc environmental risk assessment working party within the EMA.