Competition

Belgium – New Bill on allowing access to confidential agreements between government and pharmaceutical companies

Tine Carmeliet

As in several other European countries, Belgium has a system in place to allow the temporary use of certain innovative medicines on the Belgian market when no reimbursement decision has been taken due to the therapeutic effectiveness of the medicine not yet being proven. This system of “managed entry agreements” is institutionalised through the so-called Read More

On-going debate on new French Bill regarding online sale of medicines

Eveline Van Keymeulen

On 5 February 2020, the French government introduced a wide-ranging Bill to the Senate, entitled “the acceleration and simplification of public action”, which deals with a variety of matters, including new provisions on e-commerce for medicinal products (Article 34). Currently, the online sale of medicines is highly regulated in France: only medicinal products that can Read More

EU’s top court clarifies when a patent settlement agreement can infringe EU antitrust rules

Francesca Miotto

The Court of Justice of the EU (ECJ) has for the first time ruled on the issue of settlement agreements involving a value transfer (monetary or otherwise) between the holder of a pharmaceutical patent and generic drug manufacturers (so-called ‘pay-for-delay’ agreements). It has clarified the criteria governing when entry into this type of agreement can Read More

EU Advocate General suggests pay-for-delay settlement agreements may be an abuse of dominant position

Charles Tuffreau

In an opinion issued on 22 January 2020 in the case Generics (UK) Ltd e.a. vs. Competition and Markets Authority (C 307/18), Advocate General Kokott proposes that the Court of Justice of the European Union (CJEU) should find that “an agreement in settlement of a dispute between the holder of a pharmaceutical patent and a Read More

Belgian Constitutional Court overrules sales restriction for wholesale distributors of medicines

Kaat Van Delm

On 17 October 2019, the Belgian Constitutional Court rendered a final judgment , annulling Article 3.2° of the new legislation applicable to shortages of medicines in Belgium. The Article had banned the parallel export of medicines by Belgian wholesale distributors, requiring them to only supply medicines for human use to other Belgian wholesale distributors, licensed Read More