European Commission paper on Brexit and SPCs

The European Commission recently published a short document on the consequences of Brexit on SPCs.

The general message is:

Subject to any transitional arrangement that may be contained in a possible withdrawal agreement, as of the withdrawal date, Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products and Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products will no longer apply to the United Kingdom. 

The document highlights the following consequences:

- on the calculation of the duration of SPCs:

• An authorisation to place the product on the market granted by a United Kingdom competent authority as of the withdrawal date will not be considered a first authorisation to place the product on the market in the European Union for the purposes of Article 13 of Regulation (EC) No 469/2009 and Regulation (EC) No 1610/96.

• However, an authorisation to place the product on the market granted by a United Kingdom competent authority before the withdrawal date is to be considered as the first authorisation to place the product on the market in the European Union for the purposes of Article 13 of Regulation (EC) No 469/2009 and Regulation (EC) No 1610/96.

- on applications for SPCs as of the withdrawal date in the United Kingdom

As of the withdrawal date, the Medicinal Products and Plant Products regulation no longer apply to the United Kingdom.  The document footnote does indicate that for applications for an SPC filed before the withdrawal date, the EU is trying to agree solutions with the UK in the withdrawal agreement.

 Watch this space.

Re-launch of the European Commission's tender for a Study on legal aspects of SPCs in the EU

The European Commission's initial tender for a "Study on legal aspects of supplementary protection certificates in the EU" has had to be re-launched due to a very limited number of bids:  the new tender has a closing date of 27 July 2016. 

The study's purpose is stated as follows:

The contracted study shall evaluate whether a new European SPC title, with the current or broader scope within the field of pharmaceutical and plant protection products, with improved provisions, is required to meet the requirements of current and expected innovative market developments in the EU.

With this primary purpose, the study shall evaluate the current SPC framework in terms of its legal efficiency in meeting its stated objectives given the development of directly affected and related product markets.

It shall also suggest whether the existing SPC rules need to be recalibrated given identified limitations.

The results could serve as a basis for an impact assessment for a future proposal by the Commission to recalibrate the existing EU SPC rules.

Details of the tender can be found here.

European Commission Pharma Sector Inquiry - Preliminary Report

As most SPC Blog readers will be aware, a year ago, the European Commission kicked off 2008 by launching a sector inquiry into EU pharmaceutical markets under EC competition rules because information relating to innovative and generic medicines suggested that competition in the sector may be restricted or distorted. Some of the things that appear to have motivated the Commission in this endeavour was the apparent decline in innovation (measured by the declining number of new medicines reaching the market - as if producing medicines was an easy task...) as well as the delayed market entry of generic drugs. The preliminary report is out and and all 426 pages of it can be accessed here.

A whole section is devoted to SPCs (paragraphs 245-249), and includes a few words to the Commission's finding that AstraZeneca abused its dominant position by using a later date of marketing authorization (Appeal ongoing).

SPCs are also mentioned briefly under the section on Community Authorisations (paragraph 260), in conjuction with, interestingly, the only mention in the report of the so-called Bolar provision.

The final report is due out in Spring 2009.