Tag Archives: Pricing

The Commission’s Proposal on Health Technology Assessment – Will the EU Member States Accept its Mandatory Provisions?

This article was originally posted on our sister blog Global Policy Watch Introduction Health technology assessment (“HTA”) is a multidisciplinary assessment process that seeks to evaluate the added therapeutic value of health technologies (i.e., drugs, certain medical devices, medical treatments including surgical procedures, and measures for disease prevention and diagnosis) based on both clinical and … Continue Reading

German Exemptions from Mandatory Rebates for Pharma Companies Are in Line with EU State Aid Rules

The European Commission (the Commission) confirmed on 27 March 2015 that a German scheme exempting pharmaceutical companies from mandatory rebates is in line with EU State aid rules. The Commission concluded that the scheme facilitated price freezes on certain medicines, which in turn allows the costs of the public health system to be kept under … Continue Reading

Call for expression of interest to participate in early dialogue between HTA bodies and healthcare product developers

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 … Continue Reading

French Competition Authority Issues Preliminary Assessment of Pharmaceutical Sector

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 … Continue Reading

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

French Competition Authority Launches Pharmaceutical Sector Inquiry

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 … Continue Reading

Belgium – Regulatory Overview

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: „„ Medicines Law 1964. „„ Royal Decree of 14 December 2006 on … Continue Reading

Revision of the Rules on Pricing and Reimbursement of Medicines (The “Transparency Directive”) in the European Union

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 … Continue Reading

Nice Powers May Be Clipped In UK Pharmaceutical Pricing Overhaul

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 … Continue Reading

Parallel Trade in Pharmaceutical Products in Europe: the European Court of Justice’s Ruling In Gsk v Commission

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) … Continue Reading

Limiting Parallel Trade

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 … Continue Reading

Parallel Trade in Pharmaceuticals and EC Competition Law

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. … Continue Reading

Parallel Trade in Pharmaceutical Products in Europe: The European Court of Justice’s Ruling in Syfait v. GSK

Originally published as Covington Life Sciences Alert on June 1st, 2005 May a dominant pharmaceutical company refuse to supply in full the orders it receives from a wholesaler in an EU country in order to limit parallel trade in its products in the European Union? This was the question put to the European Court of … Continue Reading
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