Pharmaceuticals

Has the Orphan Regulation met its aims? A critical review of the EU’s incentives regime for rare disease patients

Eveline Van Keymeulen

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. In the article “Has the Orphan Regulation Met its Aims? A Critical Examination of the European Union’s Read More

General Court confirms strict significant benefit test on the grant of an orphan marketing authorisation

Jacqueline Bore

The General Court has confirmed in its judgment in Bristol-Myers Squibb Pharma EEIG v European Commission and European Medicines Agency (Case T-329/16) that the European Medicines Agency should take account of recently authorised medicinal products in determining whether a product under assessment should retain its orphan designation on the grant of a marketing authorisation. In the Read More

Competition authorities debate the circumstances in which intervention against alleged excessive pricing practice in the pharmaceutical sector may be justified

Francesca Miotto

In recent years, consumer organisations have been monitoring the evolution of medicine prices in the EU and have, in some cases, called for the intervention of competition authorities to protect citizens’ rights to affordable healthcare. In the context of this resurgence of interest in excessive pricing in the pharmaceutical sector, on 28 November 2018, the Read More

China announces pilot scheme for pharmaceutical tendering with minimum procurement quantities

David Shen

On 15 November 2018 the Joint Procurement Office (JPO) published its Paper on Centralized Drug Procurement in “4+7 Cities” (the Paper) which launched the national pilot scheme for tendering with minimum procurement quantities. The pilot scheme will be carried out in 11 cities: Beijing, Tianjin, Shanghai, Chongqing, Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu and Xian, Read More

New legislative proposals in Germany to encourage the use of biosimilars

Eda Zhuleku

The German Federal Ministry of Health recently released draft legislation on the safety of medicinal products – “Gesetz für mehr Sicherheit in der Arzneimittelversorgung” – GSAV In the wake of several recent safety issues, for example,  the release of contaminated pharmaceuticals with potentially carcinogenic substances in 2018, the government aims to improve the safety of medicines by stricter Read More