Regulatory & compliance

Beyond “pay-for-delay” – the EU-Commission’s investigation into patent filing practices and communication measures

Lukas Rengier

On 4 March 2021, the European Commission (Commission) opened a formal investigation into alleged anti-competitive conduct by the pharmaceutical company Teva. The Commission suspects Teva of having deployed a strategy with the intention of delaying the market entry of generic drugs that competed with Teva’s originator drug Copaxone. This may have amounted to an abuse Read More

Patent settlements and competition law – guidance from Europe’s top court

Lukas Rengier

On 25 March 2021, the European Court of Justice (ECJ) ruled for the second time on a “pay-for-delay” settlement. These are settlements of a patent dispute that involve payments or other value transfers from the originator manufacturer to the generic manufacturer in return for a delayed market entry. The ECJ dismissed appeals by the originator Read More

Covid-19 – the UK’s vaccination programme so far

Megan McMellon

As I said back in October, delivering a successful Covid-19 vaccine quickly was a huge challenge, but the diversity of the UK’s vaccine portfolio and the amendments made to the Human Medicines Regulations 2012 (HMRs) meant that the UK was in a strong position to carry out a successful mass vaccination programme as soon as Read More

France – Mediator scandal: Servier laboratories convicted of aggravated deception and manslaughter

Helene Laurent

On Monday 29 March, more than ten years after the opening of a criminal investigation and eighteen months after the start of an “out of the ordinary” trial, the Paris Criminal Court found Servier Laboratories guilty of “aggravated deception” and “manslaughter and involuntary injury” in the Mediator case. Servier laboratories marketed Mediator for years, an Read More

New pricing agreement in France includes provisions on biosimilars pricing for the first time.

Alexis Vaujany

On 5 March 2021, the President of the Economic Committee for Health Products (CEPS) and the President of the French pharmaceutical industry association (Leem) signed a new three-year framework agreement in the presence of the French Minister of Health. This framework agreement defines conventionally the rules for setting the price of medicinal products in compliance Read More