On 25 November the Commission published the long-awaited “Pharmaceutical strategy for Europe”.
From a legal perspective it is of particular interest that the Commission suggests to revise legislation on pharmaceuticals to support the digital transformation of health care, to support research and development, and to permit more competition from generic and biosimilar medicines.
The Commission lays an emphasis on the need for closer cooperation between companies, regulators and others across the product life cycle, from the R&D stage to collaboration at the procurement stage, for the parties involved in running procurement processes and health technology assessments (HTAs).
The proposed new Regulation on Data Governance, including the creation of a European health data space, is intended to set the ground for further data-related reforms that the Commission set out in its Data Strategy, which was issued in February this year.
Challenges and opportunities in the life sciences and pharma sector
The Strategy identifies challenges and opportunities eminent in the life sciences and pharma sectors, and recognises that the Covid-19 pandemic has revealed many pitfalls. The challenge of how best to strike a balance between free competition and incentivising investment in the pharmaceuticals market was also addressed in the Commission’s paper.
Closely linked to the strategy for innovation in life sciences is the Commission’s new action plan on intellectual property (IP). (https://ec.europa.eu/docsroom/documents/43845)
Potential harmonisation of the Bolar exemption
The Commission refers to an assessment of further harmonising the so-called ‘Bolar exemption’ and potential improvements of the uniform application of rules on supplementary protection certificates (SPCs), as a result of the evaluation of the SPC Regulation. (https://ec.europa.eu/docsroom/documents/43847)
At the same time, and in the framework of R&D development and incentive in the life sciences sector, the Commission published the inception impact assessment with respect to a proposal for a regulation concerning orphan medicines and medicines for paediatric patients. (feedback period still open until January)
The Commission recognised the necessity to incentivise innovation and the important role generic and biosimilar medicine manufacturers have within the EU pharmaceutical market.
It therefore considers targeted policies to support generics and biosimilars, including providing for a single assessment process across EU member states for active substances used for different generic medicines, thereby simplifying the regulatory process.
Facilitation of supply chains
In light of the challenges witnessed during the Covid-19 pandemic, the Commission has also outlined measures to facilitate supply chains for medicines and medical devices.
The Commission plans to engage with industry and other stakeholders to gain a better understanding of the functioning of global supply chains.