Healthcare

EU Commission fighting anticompetitive agreements in pharmaceuticals

18 Mar 2014, by test test

Harald Mische
Harald Mische

Harald Mische is an official at the European Commission’s Directorate General for Competition, where he currently forms part of the team in charge with antitrust enforcement in the pharma sector. He will be presenting at the 2014 Pharmaceutical Law conference, to be held on the 29-30 May in Sydney about competitive law enforcement in the EU. In the lead up to the event, Harald took the time to speak to us about EU antitrust laws, the impact of pay-for-delay cases and some of the key differences between EU and Australian Competition Law.  

In what ways does the EU antitrust law protect competition and enable market integration?

Harald Mische: EU antitrust law fights against anticompetitive agreements and cartels to prevent companies from creating market barriers in the Single European Market and restricting competition. In addition, the prohibition of abusive practices ensures that new entrants can challenge dominant incumbent undertakings. With these tools as well as merger control, competition policy creates the conditions for well-functioning, open markets. In turn, open markets enhance the integration of Europe’s economies.

What has been the impact of the outcomes of the Lundbeck, Fentanyl and Servier pay-for-delay cases?

Harald Mische: In 2013, the Commission adopted its first infringement decisions regarding pay-for-delay agreements in Lundbeck and Fentanyl. However, in Servier the Commission has only issued a Statement of Objections in 2012, expressing preliminary concerns. Commissioner Almunia made clear that the pay-for-delay agreements prohibited in Lundbeck and Fentanyl were “simply unacceptable”. Together, these cases have brought important clarifications on how European competition law on restrictive agreements applies to pay-for-delay agreements. In my view, the pharmaceutical industry has already reacted. In our Patent Settlement Monitoring Reports, we have been observing an increase in settlements overall but a decrease in potentially problematic settlements.

What do you feel are the key differences between Australian and EU Competition Law? Are there key lessons to be learnt from either?

Harald Mische: A key difference between Australian and EU Competition Law is for instance that in EU Competition Law, there exists no criminal offense for cartel activities. A second difference is that EU enforcement is based on a purely administrative procedure, where the Commission carries the responsibility for adopting infringement decisions and for imposing fines. Learning from each other is in my view rather a constant process, whereby different authorities deal with different cases that arise in their jurisdiction. Through constantly exchanging experience, we deepen our understanding of markets and competition, and of how competition law should be applied.

Pharmaceutical Law P14A21You are speaking at the Pharmaceutical Law Conference. What are you hoping to get out of the event? Are there any presentations or discussions you are particularly looking forward to?

Harald Mische: IIR Healthcare has put together an exciting program covering a broad range of very interesting pharma law topics. Considering my own specialization, I am of course particularly looking forward to learning about how Australian competition law is applied to the pharmaceutical sector both regarding abuses and in the area of mergers. I also look very much forward to learning about Australian reimbursement decisions and the pricing system, as these provide insight into the functioning of pharmaceutical markets in Australia.

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