EU Parliament votes on Pharmaceutical Legislation Amendments
On the 19th of March the EU Parliament Committee on the Environment, Public health and Food Safety (ENVI) voted on the Pharmaceutical Directive and Regulation. The vote confirmed the previous reached compromise amendments between the parties. With a single yes/no vote to the whole package of amendments for each the directive and the regulation passed in the ENVI Committee (Directive: 66 votes in favour, two against and nine abstentions, Regulation: 67 votes in favour, six against and seven abstentions). With this, the ENVI committee has finished the work on the package. The plenary voting will be held mid-April, where the package is expected to pass as it stands. This will then bring the first reading of the package to an impressively quick end. Further work for the EU Parliament on the Pharma package will only arise with the start of the trilogue, as soon as the Council has reached an agreement and voted on its position.
Let’s have a quick look into the Parliament’s decision in respect to the priorities of the Childhood Cancer Community:
Clear wins are that the molecular target provision stands as wanted, stakeholders are included in the decision-making process in defining the guidelines for unmet medical needs and active stakeholder involvement in the establishment of the critical medicines list. Furthermore, the hospital exemption clause is still included, making the treatment and research for UMN in hospitals possible as usual. Another positive is that the repurposing of authorised medicinal products still includes an obligation for the market authorisation holder to update the label with a from an NGO submitted and by the EMA positively approved new therapeutic indication.
Not included in the compromise amendments is a paediatric specific first-in-child incentive. Nevertheless, the Parliament amended that 11 years market exclusivity shall be given for development of orphan medicinal products addressing a high unmet medical need, under which paediatric cancer falls.
Equal Access was a highly discussed topic during the Parliamentary process. The Commission’s Proposal of 2 years extra of market exclusivity for making the medicine available within 2 to 3 years after the market authorisation was abandoned. Instead, the Parliament came up with their own new proposal. The advantages of this new proposal are the introduction of an obligation with penalties instead of an incentive, the introduction of strict timelines in the HTA process enforcing the Directive 89/105/EEC and the introduction of Transparency through an EU Access to Medicines Notification System. The definition of unclear wording in the exemption clauses of the article needs further development.
The EU Parliament furthermore went against the Commission’s Proposal idea of bringing the regulatory data protection period baseline down to 6 years and then through specific incentives back up to 8 years. The Parliament compromise amendments brings the regulatory data protection period baseline back up to 7 years and 6 months.
The next step in the Revision of the EU Pharmaceutical Legislation is the Council’s amendments and voting process. After that the trilogue will start. SIOPE stays invested in the file and now has its full attention to the Council for the nearer future.