Alignment of Pharmaceutical Strategy for Europe with the Action Plan on IP

Managing IP is part of Legal Benchmarking Limited, 1-2 Paris Gardens, London, SE1 8ND

Copyright © Legal Benchmarking Limited and its affiliated companies 2025

Accessibility | Terms of Use | Privacy Policy | Modern Slavery Statement

Alignment of Pharmaceutical Strategy for Europe with the Action Plan on IP

Sponsored by

maiwald-logo-cropped.PNG
guillaume-perigois-0nrkvdda2fw-unsplash-1.jpg

Dr Gisela Grabow of Maiwald explains the importance of a comprehensive approach to the revision of pharmaceutical legislation that considers the relationship with IP rights and the Action Plan on IP

On September 28 2021, the EU Commission published a report on the public consultation on the revision of the EU's pharmaceutical legislation, as part of the Pharmaceutical Strategy for Europe (Pharmaceutical Strategy), adopted in November 2020.

Such Pharmaceutical Strategy inter alia focuses on supporting a competitive and innovative European pharmaceutical industry, which should ideally go hand in hand with the strategy for innovation in life sciences and pharmaceuticals in the Commission’s Action Plan on Intellectual Property (Action Plan on IP).

In the context of the Action Plan on IP, the EU Commission underlines that is actively involved in strengthening the protection and enforcement IP rights, and recognises efficient Intellectual Property (IP) systems as being important in promoting investments, innovation, growth and business activities of EU companies. Further, the Commissioner for Trade Phil Hogan emphasised: “As much as 82% of all EU exports is generated by sectors which depend on intellectual property.”

According to the report published on the consultation, the pharmaceutical industry supports the improvement of the regulatory system and promotion of innovative manufacturing; addressing the causes for supply shortages and supply chain risk, whilst the generics industry requests increased competition, revision of procurement criteria and

IP rights.

For the pharmaceutical industry and the foodstuff industry (concerned by Regulation (EU) No. 2019/1381) the partial parallelism of the incentives put forward in the Action Plan on IP and of the planned measures set forth in the Pharmaceutical Strategy as well as partial deviations make it difficult to assess the legislative framework.

It is therefore of utmost significance to align the legislative measures on ‘supporting competitiveness, innovation and sustainability of the EU's pharmaceutical industry and the development of high quality, safe, effective and greener medicines’ with envisaged legislation to incentivise the use and deployment by small and medium-sized enterprises (SMEs) and facilitate access to and sharing of intangible assets.

There are a number of issues which have to be carefully assessed in terms of addressing pitfalls in existing legislation, for instance with respect to a unified supplementary protection certificate (SPC) grant mechanism and/or a unitary SPC title.

In the context of this example, the Commission is currently preparing an impact assessment for supplementary protection certificates for pharmaceutical and plant protection products, in the context of the Action Plan on IP, and the importance of SPCs is also mentioned in the Pharmaceutical Strategy, but only with a short reference to the Action Plan on IP.

Hence, in the revision of the pharmaceutical legislation envisaged by the Commission for Q1 2022, an alignment with amendments to IP-related legislation is of vital importance.

This assessment should have respect to concerns as to whether the increase in transparency and access is more important than keeping research confidential and IP sufficiently protected, a clear pitfall in the Transparency Regulation (Regulation (EU) No. 2019/1381). For IP related to plant varieties, which is recognised in the Action Plan on IP, such a pitfall should be avoided.

Another example of deviating interests is the proposal to impose greater ‘conditionality’ on companies to market a medicine in all EU countries.

The few examples mentioned here make evident how important it is that a comprehensive approach in the revision of pharmaceutical legislation takes into account the relationship with IP rights. And in terms of IP rights legislation, access, transparency and affordability of medicines should be aligned with improved protection mechanisms.

 

Dr Gisela Grabow

Principal, Maiwald

E: grabow@maiwald.eu

 

 

more from across site and SHARED ros bottom lb

More from across our site

Deborah Kirk discusses why IP and technology have become central pillars in transactions and explains why clients need practically minded lawyers
IP STARS, Managing IP’s accreditation title, reveals its latest rankings for patent work, including which firms are moving up
Leaders at US law firms explain what attorneys can learn from AI cases involving Meta and Anthropic, and why the outcomes could guide litigation strategies
Attorneys reveal the trademark and copyright trends they’ve noticed within the first half of 2025
Senior leaders at TE Connectivity and Clarivate explain how they see the future of innovation
A new action filed by Nokia against Asus and a landmark ruling on counterfeits by South Africa’s Supreme Court were also among the top talking points
Counsel explain how they’re navigating patent prosecution matters and highlight key takeaways from Federal Circuit cases
A partner who joined Fenwick alongside two others explains what drew her to the firm and her hopes for growth in Boston
The England and Wales High Court has granted Kirkland & Ellis client Samsung interim declaratory relief in its ongoing FRAND dispute with ZTE
A UDRP decision that found in favour of a small business in a domain name dispute could encourage more businesses to take a stand in ‘David v Goliath’ cases
Gift this article