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The search returned 4 results.

The CJEU’s First Ruling On The Classification Of Software As A Medical Device: A Predictable Scenario With A Possible Cliff-hanger? journal article

Eveline Van Keymeulen, Jacqueline Bore

European Pharmaceutical Law Review, Volume 2 (2018), Issue 1, Page 47 - 55

Case C-329/16, Judgment of the Court (Fourth Chamber), Syndicat nationale de l’industrie des technologies médicale (Snitem), Philips France v Premier ministre, Ministre des Affaires sociales et de la Santé [2017] ECLI:EU:C:2017:947


Rewarding Innovation: Pharmaceutical Incentives as a Crucial Instrument to Foster Public Health journal article

Laëtitia Bénard, Jacqueline Bore, Eveline Van Keymeulen

European Pharmaceutical Law Review, Volume 2 (2018), Issue 2, Page 72 - 84

Pharmaceutical law aims to promote public health both by ensuring the highest standards of safety in medicinal products placed on the market and by encouraging the research and innovation that will lead to new treatments. European Union legislators have supported Member States in achieving these aims but have been careful to introduce measures in such a way so as prevent creating barriers to trade and a distortion of competition. These measures have inevitably meant an erosion of the proprietary intellectual property rights that are intended to reward innovators in industrial sectors. Incentives such as exclusivity periods and supplementary protection certificates redress the balance between public health and proprietary rights to some extent and play a role in continuing to attract investment to the pharmaceutical sector. Member States determine priorities for their national health budgets, but increasing budgetary pressures may undermine the incentives offered at EU level. European Union legislators should carefully preserve existing incentives in order to maintain the competitive landscape so that access by patients in the EU to novel and innovative treatments is not undermined. This article examines the existing incentives for pharmaceutical innovation in the EU and the legal and practical limitations of the regime. It supports the view that the current system balances internal market and public health objectives, often at the expense of companies’ proprietary rights, and concludes that any attempts to undermine or further weaken these incentives is likely to be detrimental to public health.


Has the Orphan Regulation Met its Aims? journal article

A Critical Examination of the European Union’s Regime Incentivising Research and Development of Medicines for Patients with Rare Diseases

Laëtitia Bénard, Jacqueline Bore, Eveline Van Keymeulen

European Pharmaceutical Law Review, Volume 2 (2018), Issue 4, Page 179 - 192

By the 1990’s the European Union had fallen behind other developed economies in the encouragement and support its pharmaceutical regulatory framework offered to the development of new treatments for rare diseases. The aim of the Orphan Regulation was to remedy this. We examine critically the interplay of the legal instruments underpinning the scheme of orphan incentives with the judgments of the Court of Justice and conclude that the definitions and tests embodied by the Orphan Regulation, which decide which products should be rewarded, have served patients with rare diseases well.


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