Pharmaceutical Strategy for Europe
The new pharmaceutical strategy for Europe is a key pillar of the European Health Union, which President von der Leyen called for in her 2020 State of the Union speech. It covers the full lifecycle of a medicine including R&D, clinical trials, marketing authorisation, manufacturing, pricing and reimbursement, access and IP protection.
The aims of the strategy are to promote accessibility and affordability of medicines, and to ensure the European pharmaceutical sector remains innovative and world-leading. The coronavirus pandemic has brought the health sector into sharp focus this year, and a goal of the strategy is to help to establish a crisis-resilient EU pharmaceutical system.
The strategy sets out four main objectives:
- Ensure access to affordable medicines and address unmet medical needs (e.g. in the area of cancer)
- Support innovation, competitiveness and sustainability of the EU’s pharma industry and the development of high quality, safe, effective and greener medicines
- Enhance crisis response mechanisms and address security of supply
- Ensure a strong EU voice in the world by promoting a high level of quality, efficacy and safety standards
In term of next steps:
- The strategy will be discussed at political level at the EPSCO (Employment and Social Affairs Council) meeting of 2 December 2020.
- Implementation will start immediately after adoption and will include legislative and non-legislative actions.
- The actions will be rolled out gradually starting with the first proposals in the coming months, including the revision of the legislation on rare diseases (Orphans and Paediatric Regulations).
- An EU Health Emergency Response Authority is proposed for 2021.
- Depending on the evaluation process, the strategy plans a proposal for revision of the basic pharmaceutical acts (i.e. Directive 2001/83/EC relating to medicinal products for human use; and Regulation 726/2004 laying down EC procedures for the authorisation and supervision of medicinal products) in late 2022.
The strategy is mostly focussed on IP and regulatory issues, but notes that the proposed policies will be accompanied by enforcement of the EU competition rules. In particular, it refers to the 2019 Report on competition enforcement in the pharmaceutical sector.
Action Plan on Intellectual Property
The new Intellectual Property Action Plan aims to build on the EU’s strengths in the IP sector by “upgrading the EU’s framework, where needed, and putting in place well-calibrated IP policies to help companies capitalise on their inventions and creations, whilst at the same time ensuring that inventions and creations are serving economy and society at large“. It identifies 5 current challenges and 5 key focus areas, with specific proposals for action to:
- upgrade the system for IP protection,
- incentivise the use and deployment of IP, notably by SMEs,
- facilitate access to and sharing of intangible assets while guaranteeing a fair return on investment,
- ensure better IP enforcement, and
- improve fair play at global level.
Within these 5 key focus areas, some highlights of what the action plan discusses are:
- supporting the launch and rapid roll out of the unitary patent system in 2021. It also floats the possibility of introducing “a unified SPC grant mechanism and/or create a unitary SPC title“
- new licensing tools and a system to coordinate compulsory licensing (2021–2022)
- revising the EU legislation on design protection (Q4 2021)
- a new approach to the way geographical indications (GIs) are protected, and the possibility of an EU protection system for non-agricultural GIs (Q4 2021)
- evaluating the plant variety legislation (Q4 2022)
The wider picture
Both the strategy and action plan are in synergy with the new Industrial Strategy for Europe and the priorities outlined in the European Green Deal, Europe’s Beating Cancer Plan, and the European Digital Strategy.