The European Commission published, in the afternoon of 2 June, its roadmap on the future pharmaceutical strategy, which remains relatively opaque on the way to achieve it. In accordance with the ‘Better Regulation’ procedure, stakeholders can send their comments until 7 July 2020. This will be followed by a public consultation prior to the publication of the strategy at the end of the year.
Lessons learned from the Covid-19 pandemic
This strategy, which will take the form of a communication, will aim to “ensure affordability, sustainability and security of supply”, said Health Commissioner Stella Kyriakides. “The coronavirus pandemic has showed us more than ever that we need to have a crisis-resistant system and the means to produce medicine within the EU to ensure timely access to essential medicines for our citizens and hospitals in all circumstances”. The European Commission thought for a while about hastening its work and presenting its strategy at the end of July, but it finally changed its mind, preferring to maintain the initial timetable, which sets the deadline for the fourth quarter of 2020.
By midday, two anonymous comments had already been posted on the Commission's website. The European Federation of Pharmaceutical Industries and Associations (EFPIA) had also issued a press release, stressing the importance of “medical innovation” and reiterating its call for the creation of a High Level Forum on better access to innovation in health.
The Commission outlines its specific objectives
However, the roadmap does not bring much new to what was already known. It nevertheless outlines the specific objectives that the Commission intends to achieve.
On the product availability, it raises the idea of reviewing incentives and obligations for innovation, market entry and continuous supply of products. It also talks about promoting regulatory and administrative simplification, in particular through better use of electronic product information or multilingual packaging, and increasing transparency in the sector.
As regards the level of prices charged, the Commission mentions better European cooperation, but excludes any regulatory intervention in this area, which falls within the competence of the Member States. It also refers to its proposal on common health technology assessment, which is currently blocked in the EU Council.
Regarding innovation, the Commission's proposal raises the idea of reviewing procedures to accelerate the development and evaluation of medicines of major health interest by making greater use of new technologies and, drawing lessons from the Covid-19 pandemic, to “strengthen mechanisms for cooperation and coordination among regulatory authorities” in the event of emerging health threats.
The last part is thestrategic autonomy vis-à-vis non-Member State producers. Here the Commission is calling for a level playing field for European companies through harmonised international standards for product quality and safety. It also talks, without giving further details, about encouraging and supporting European production capacity for active pharmaceutical ingredients and starting materials.
Work Calendar
The publication of this roadmap is the first step in a long process. Following the comment mechanism, the Commission will publish a summary on its website before the summer. It will launch, as well, a public consultation before the summer. The subject will also be discussed in the Commission's Pharmaceutical Committee and in the European Parliament, through the report by Mrs Colin-Oesterlé (EPP, France).
The Commission specifies that it will not launch an impact assessment before the Communication.
It should also be noted that the institution plans to publish the results of a study on medicine shortages in mid-2021.
Link: https://bit.ly/36Uf766 (Original version in French by Sophie Petitjean)