Following the federal election in September 2021, Germany will soon be led by a new three-party coalition, the so-called “traffic light coalition”, composed of the Social Democratic Party (SPD), the Liberal Democrats (FDP) and the Green Party (Die Grünen). This new federal government led by the new chancellor Olaf

On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and machine learning (“AI/ML”).

Purpose

AI

On 1 July 2021, the new French rules on early access to unauthorized medicinal products and off-label use of authorized medicinal products entered into force.  The rules were introduced by the Social Security Financing Law for 2021 (LOI n° 2020-1576 du 14 décembre 2020 de financement de la sécurité sociale pour 2021 or “LFSS 2021”, available here).  The reform seeks to simplify existing rules, make early access and off-label use more predictable for all users, and ensure the sustainability of these programs for the public health insurance system.  In this blog, we present an overview of the new rules.

Continue Reading New Early Access and Off-Label Use Rules in France

On May 20, 2021 there was a major ransomware attack on the Irish health system.  The centralized HSE (Health Service Executive) which provides and manages healthcare for the Irish population was targeted on May 14, and has seen significant disruption since.  It has described the attack as a ‘zero-day threat with a brand new variant of the Conti ransomware.’
Continue Reading Major Cyber-Attack on Irish Health System Causes Commercial Concern

On 10 September 2020, the German Federal Social Court (Bundessozialgericht – “BSG”) has issued an important decision with significant impact on the drug pricing and reimbursement system. It ruled that a pharmaceutical company can file a direct legal action against the early benefit assessment in the so-called AMNOG process. This was not possible so far.

On 3 July 2020, the German parliament passed a draft bill (German language) for patient data protection and for more digitalisation in the German healthcare system (Patientendaten-Schutz-Gesetz). The draft bill is currently in the legislative procedure and is expected to enter into force in autumn 2020.

One of the main objectives of the

NHS England has recently published draft proposals on how it plans to approach doing commercial deals with pharmaceutical companies for branded medicines. This draft “Commercial Framework” is now open for comment and consultation (stakeholders can submit their views here). The consultation period ends on 10 January 2020, with Commercial Framework expected to be finalized

The European Data Protection Board (“Board”) released an opinion on January 23, 2019, on the intersection between the EU General Data Protection Regulation (“GDPR”) and the Clinical Trials Regulation (“CTR”).  The opinion considers a Q&A on this topic prepared by the European Commission’s Directorate General for Health.  The Directorate General decided to create this Q&A because of perceived contradictions between the GDPR and the CTR, in particular in relation to the legal basis (e.g., the use of consent) and the further use of clinical trial data. (See also here).
Continue Reading European Data Protection Board releases Guidance on Intersection of the GDPR and the Clinical Trials Regulation

The EU pharmaceutical industry landscape is in significant flux. There are many pressures to provide new therapies and to make them available more early and for as many qualifying patients as possible. In that context, the industry model and the role of exclusivity rights as a tool to stimulate innovation are being discussed. At the same time, discovering and developing new products is more complex and requires a collaborative effort. This happens against the background of new rules on medical devices and the protection of personal data, which are, for instance, relevant in assessing clinical effectiveness and relying on real world evidence.

Three members of the Covington European Life Sciences team will be speaking on these topics at the EU Pharmaceutical Law Forum being held in Brussels on 16-18th May.
Continue Reading Exploring the EU Horizon for Pharma

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 control.

Council Directive 89/105/EEC allows Member States to introduce price freezes on pharmaceutical products. Article 4(2) of the Directive states that derogations from price freezes can be justified for “particular reasons”. Based on these provisions, Germany introduced a mandatory manufacturer’s rebate of 16% on certain prescription medicines sold to public sickness funds and private health insurers between 1 August 2010 and 31 December 2013. Also, under the Article 4(2) exemption, Germany set up a system of derogations for companies whose financial viability would be threatened by the rebate.
Continue Reading German Exemptions from Mandatory Rebates for Pharma Companies Are in Line with EU State Aid Rules