On April 27 2023, the European Commission presented a proposal for the reform of the general pharmaceutical legislation in the EU. The proposal is based on the Pharmaceutical Strategy for Europe and is divided into a Directive on the creation of an EU code for medicinal products for human use and a proposal for a Regulation establishing EU procedures for the authorisation and supervision of medicinal products for human use and establishing rules for the European Medicines Agency.
The Pharmaceutical Strategy’s objectives
The Pharmaceutical Strategy for Europe, which includes legislative and non-legislative measures, serves four main objectives, as defined by the European Commission:
To ensure access to affordable medicines for patients and to address unmet medical needs (particularly in the areas of antimicrobial resistance and rare diseases);
To promote the competitiveness, innovation and sustainability of the EU pharmaceutical industry, as well as the development of high-quality, safe, effective and more environmentally friendly medicines;
To improve crisis preparedness and response mechanisms; and
To ensure a strong EU voice in the world by promoting high levels of quality, efficacy and safety standards.
The proposal
Commencing with an Impact Assessment and public consultation in March 2021, the European Commission had considered three options, and had commissioned a study for the evaluation and impact assessment of the EU's general pharmaceutical legislation (Directive 2001/83/EC and Regulation (EC) No. 726/2004).
The proposal for the Directive includes substantial and numerous amendments to Directive 2001/83/EC, intending to repeal and replace it. From the three options proposed in the initiative, the European Commission opted for option C, including:
Variable protection periods (standard and conditional periods);
A balance between innovation and advanced access to medicines; and
Early notification of supply shortages and the introduction of the environmental risk assessment.
The main issues
Issues of particular relevance for stakeholders are provisions pertaining to market access (data protection, market exclusivity, Bolar exemption, vouchers) on the one hand, and the marketing of medicines on the other. The current regulation of data protection for a period of eight years from the approval of the medicinal product and the subsequent market exclusivity, with the possibility of extending the protection by a year if the medicinal product is approved for a new indication in which the medicinal product is of significant benefit (the 8+2+1 rule), would become obsolete.
In the context of intellectual property (IP) rights and pharmaceuticals, it is worth taking a closer look at the interaction of IP rights and data protection.
The Impact Assessment on the recently published proposals for the Directive and Regulation revising the pharmaceutical legislation refers to the Intellectual Property Action Plan and the modernisation of the Supplementary Protection Certificate (SPC) system, and states that other policies are more appropriate than the amendments to the pharmaceutical legislation to promote innovation: "In this context, other policies and initiatives working in synergy with this revision, like the R&I [research and innovation] policy, industrial strategy, the EU system of intellectual property rights (patents and supplementary protection periods), the creation of the European Health Data Space, are key factors to promote innovation and EU competitiveness" (Commission Staff Working Document, Impact Assessment Report, SWD(2023) 192 final).
The suggested provisions on data protection would be demanding for originators, particularly with regard to possible extensions of the envisaged six-year standard period.
The argument put forward in the Impact Assessment is that the introduction of the conditions for the extension of the protection periods will lead to additional incentives for market entrance in all member states. Whether these changes will benefit competition in the EU and at the same time promote innovation remains to be seen.
A key challenge in creating a new system
The proposals reflect the challenge in creating a future-proof and crisis-resistant EU pharmaceutical system in the face of different stakeholder interests. The European Commission’s consultation period ends on June 27 2023.
