Market access for generics and biosimilars to be improved
New EU intellectual property legislation to strengthen the position of European manufacturers of generics and biosimilars
MS / SJS – 02/2019
the future, EU-based manufacturers of generics and biosimilar will be allowed
to manufacture their products in Europe during the term of a Supplementary
Protection Certificate (SPC). Stockpiling will also now be permitted. This
means that European manufacturers of generics and biosimilars will be able to
produce a stockpile of their product that they can put on the EU market on the
day after the SPC expires. The aim of the Commission’s new rules on
intellectual property is to strengthen the competitiveness of EU-based manufacturers
of generics and biosimilars. The European Parliament, the Council and the
Commission reached agreement at the beginning of February 2019.
Protection Certificates extend patent protection for pharmaceutical products
that must undergo compulsory lengthy testing and clinical trials before obtaining
regulatory approval. An SPC can extend a patent right for up to five years.
health insurance providers have
also called for this adjustment so that generics and biosimilars have faster
access to the market in order to relieve the strain on national health budgets
and provide access to affordable medicines. Pharmaceutical companies which
carry out research have criticised this as undermining patent protection
A formal agreement has yet
to be reached by the Council and Parliament. The proposal is based on
Regulation (EC) No 469/2009 of 6 May 2009 concerning the supplementary
protection certificate for medicinal products. The Regulation will then apply
directly in all Member States and becomes binding 20 days after publication in
the Official Journal.
information is available here.