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