Daniel Gueguen

The long-awaited Delegated Acts Register has arrived but that doesn’t mean an end to the usual opacity, as we can see with files like formaldehyde and the on-going reform of supplementary protection certificates (SPC). The latter is an IP tool that extends patent rights by 5 years, helping manufacturers of pharma and plant health products to cover the extremely high cost of R&D and market authorisation.

Last year, the Commission began an impact assessment on modernising the EU law on SPCs. In October it launched a public consultation. However, only a few days after the consultation closed officially on 4 January 2018, DG GROW indicated it plans to fast-track a legislative proposal introducing a ‘manufacturing waiver’ that would permit a manufacturer to produce a generic of an original product still under SPC protection and export it outside the EU. This means profound changes to the delicate balance between free competition and the attractiveness of investing in research.

The Commission is effectively disregarding the feedback submitted during the public consultation by not taking sufficient time to analyse the contributions and rushing through its final initiative. In other words, it is effect using the impact assessment and public consultation to validate a decision already taken, treating them as boxes to tick off a list. This shows a lack of respect to experts, stakeholders and civil society.

Author :


  1. The (possible) proposal of an SPC manufacturing waiver is not really a “tick-the-box” action of the Commission, unless the Commission takes 3 years to tick a box.

    In effect, the Commission considered this possible initiative in its Single Market Strategy already in 2015.

    Then a huge study by Charles River Associate (CRA) was conducted and all relevant stakeholders (incl. both the generic industry and the originator industry – i.e. EFPIA and its members) were consulted and replied to several well detailed questions.

    On the basis of all these feedbacks, the CRA study concludes that there is a huge positive impact for the European industry (ie. thousands of jobs and economic growth) and for the society (ie. more competition and BILLIONS of savings for EU healthcare systems). It also confirms that the waiver does NOT reduce the SPC protection and does NOT change the incentive to invest in R&D. So we struggle to understand how “This means profound changes to the delicate balance between free competition and the attractiveness of investing in research”, as you claim.

    The CRA study was concluded in February 2016. It took the Commission almost 2 years to publish it together with the public consultation (Oct 2017).
    So, we struggle to see the “rush” you refer to. We struggle to see the “tick-the-box strategy” you mention. We actually think it is taking too long to introduce a small amendment that has NO impact on the IP protection and a HUGE impact for patients and for the development of medicines in Europe.

    Finally, we must have a different perception of the concept of “respect”. Since the SPC in practice delays competition of lower cost medicines after it expires, the real “lack of respect” here is not towards experts or stakeholders. The “lack of respect” is towards patients that for months are prevented from treating their cancer or HIV with lower cost medicines which are artificially kept out of the market beyond what is required by the law!

    Legal and External Relations Director at Medicines for Europe

    1. Dear Mr Napolitano,

      I thank you for your reply, but I believe you have misinterpreted the message of my article. My reference to ‘tick-the-box’ concerns specifically the Commission’s approach to the 12-week consultation.

      In my view it is inappropriate for the Commission to decide on its final policy approach without at least taking the time to analyse the hundreds of contributions it has received. Indeed, this is not an isolated problem: just before Christmas the Commission held a vote on formaldehyde barely 24 hours after the public consultation ended, despite receiving almost 100 comments from citizens and stakeholders.

      Regardless of whether you think introducing an SPC waiver is a good or bad thing (in fact, I make no judgment on that question in my article), the Commission surely has to respect minimum standards of Better Regulation, instead of treating consultation as a box to be ticked. Transparent and open decision-making is ultimately beneficial for all of us.

Leave a Reply