Pricing

A call for expression of interest addressed to healthcare product developers who would be interested in engaging in early dialogues (EDs) with Health Technology Assessment (HTA) bodies was launched in December 2013 and will stay open until October 2014.  The call concerns developers of both medicinal products and medical devices.

The European Commission defines HTA as a means to assess the ways science and technology are used in healthcare and disease prevention.  It covers medical, social, economic, and ethical issues and provides policy-makers with objective information, so they can formulate health policies that are safe, effective, patient-focused and cost-effective.  According to the Commission, HTA should be transparent, unbiased, robust and systematic, firmly rooted in research and the scientific method.
Continue Reading Call for expression of interest to participate in early dialogue between HTA bodies and healthcare product developers

The French Competition Authority (“FCA”) is currently investigating the intensity of competition in the supply of pharmaceuticals.  The investigation was launched in February 2013 and concerns all levels of the medicinal distribution chain (pharmaceutical suppliers, wholesalers and retailers).

In July 2013, the FCA submitted to public consultation its initial assessment of the pharmaceutical sector.  The FCA raised multiple concerns at every level of the distribution channel.  The main areas of concern identified by the FCA are as follows:
Continue Reading French Competition Authority Issues Preliminary Assessment of Pharmaceutical Sector

EU competition law imposes significant constraints on the ability of dominant firms in the life sciences sector to freely determine the price of their products. Price cuts and loyalty-inducing rebates can be abusive. So can excessively high or discriminatory prices.  Vertically-integrated firms that control an important input must also ensure that the prices they charge upstream and downstream leave a sufficient margin to downstream competitors that rely on the upstream input.

Although these constraints apply only to firms that hold a dominant position on the relevant market where they are active, the importance of these limitations should not be underestimated considering that competition authorities are adopting very narrow market definitions.

Continue Reading The Limits Imposed by EU Competition Law on Pricing by Dominant Firms in the Life Sciences Sector

In February 2013, the French Competition Authority (“FCA”) launched an inquiry into the pharmaceutical sector, examining each level of the medicinal distribution chain (pharmaceutical suppliers, wholesalers and retailers).  The FCA is likely to focus on a broad range of issues, including:

  • Generic entry: The inquiry will likely examine pay-for-delay arrangements and other issues relating to generic entry.  Both the FCA and the European Commission are currently investigating several cases relating to practices allegedly aimed at disrupting generic entry.   The FCA has also indicated that, following the sector inquiry, it may publish specific guidance on practices affecting generic entry.
  • Parallel trade: In 2007, the FCA cleared  (subject to certain commitments) the quota systems implemented by several major pharmaceutical companies.  Quota systems are aimed at rationalising wholesale distribution and limiting parallel trade.  The FCA may use the sector inquiry to revisit the issue of parallel trade and re-examine the quota systems.
    Continue Reading French Competition Authority Launches Pharmaceutical Sector Inquiry

Article originally published in the Life Sciences Handbook, 2012

1. What is the regulatory framework for the authorisation, pricing and reimbursement of drugs, biologicals and devices (as they are termed in your jurisdiction)?

Legislation
The main legislative acts regulating medicinal products are the:

Originally published as Covington E-Alert on March 1st, 2012

Today the European Commission published its long awaited proposal for the revision of the so-called Transparency Directive. The Directive lays down procedural guarantees for the systems that regulate the pricing and reimbursement (“P&R”) of medicines in the thirty EU and EEA Member States. The revision aims

Originally published as Covington E-Alert on November 10, 2010

The UK government will consult in the coming year on proposals to move the UK’s National Health Service (NHS) towards a value-based system of pricing medicines from 2014. While official details are yet to be published, it is expected that doctors will be given powers to

Originally published as Covington E-Alert on October 9, 2009

May a pharmaceutical company charge its wholesalers one price for products to be resold under the national healthcare reimbursement rules, and another, higher price for products to be resold in another EU member state? This was the question addressed by the European Court of Justice (ECJ)

Article originally published in Competition Law Insight on November 25, 2008

May a dominant pharmaceutical company refuse to supply in full the orders it receives from a wholesaler in an EU member state in order to limit parallel trade in its products in the European Union? This was the question addressed by the European Court

Article originally published in PLC Cross-border Life Sciences Handbook, 2007/08

Apart from patent disputes linked to generic entry, perhaps no issue has spawned more litigation in the European pharmaceutical sector than parallel trade. At the root of the problem are price differences among member states for pharmaceutical products which are caused by national price controls.