The pharmaceutical industry in the EU, being the second largest market in the world for pharmaceuticals, is immensely important: the sector provides 800,000 direct jobs and a € 109.4 billion trade surplus. Still, the EU has not made any major review of the pharmaceutical legislation in the union for almost 20 years.
However, in November 2020 a new pharmaceutical strategy for Europe was released and adopted. Some of the aims of the review are to improve and ensure access to affordable medicines, foster innovation, including in areas of unmet medical need, improve security of supply, adapt to new scientific and technological developments and decrease the level of bureaucracy. The overarching goals involve increasing the competitiveness and innovation of the EU’s pharmaceutical industry, to improve patient safety and also, with the Covid-19 pandemic fresh in mind, enhancing crisis preparedness. The initiative aims to result in the proposal of new EU legislation.
The Commission puts a key focus on targeted policies to support increased generic and biosimilar competition and exploiting the potential savings therefrom. More concretely this could, according to the Commission, address the so called “Bolar” provision and involve further clarifying the provisions for the conduct of trials on patented products to support generic and biosimilar marketing authorisation applications.
Furthermore, the Commission highlights the need for competition law scrutiny, pointing out the strategies sometimes used by originator companies to prevent entry or expansion of the more affordable medicines from their generic and biosimilar competitors.
Another of the concrete proposals is to facilitate the authorisation and life-cycle management for different generic medicines by providing a single assessment process across the Member States for the active substance used for a certain generic medicine.
On September 28, 2021, the EU Commission initiated a public consultation running until December 21, 2021, inviting the general public as well as stakeholders to put forward their views on the needs for revision of the EU pharmaceutical legislation.
Gulliksson encourages all stakeholders to participate in the public consultation and will itself monitor the development of the legislation process closely.
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