Inside EU Life Sciences

Updates on Legal Developments in the EU Life Sciences Industry

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Inside EU Life Sciences

German Patent Law Reform Would Introduce “Disproportionality” Defence

By Ulrike Elteste

February 16, 2021

On 27 January 2021, the German Parliament discussed a draft law that would limit a patent owner’s ability to stop the production and distribution of an infringing product. The new law would enable the infringer to rely on a defence of “disproportionate hardship” against an otherwise justified cease-and-desist claim. While the German Association of the Automotive Industry welcomes these changes, citing “unreasonable” royalty demands for standard essential patents for information and communications technology used in…

Inside EU Life Sciences

EU Adopts Export Authorization Scheme for COVID-19 Vaccines and their Active Substances

By Bart Van Vooren & Loïc Waty

January 30, 2021

On January 30, 2021, the European Commission published the Regulation establishing an export authorization and notification scheme relating to COVID-19 vaccines and their active substances. It applies “for a limited duration” to COVID-19 vaccines covered by Advanced Purchased Agreements (“APAs”) concluded with the Union. As regards APAs contracted by third countries, “the Commission will endeavour that the expectations of these countries to obtain their deliveries will be met as much as possible.” This post briefly…

Inside EU Life Sciences

Belgium Amends Compassionate Use and Medical Need Program Rules to Expand Access

By Bart Van Vooren, Rosa Oyarzabal & Léna Beley

January 15, 2021

On 13 December 2020, Belgium amended its rules regarding compassionate use and medical need programs to confirm that authorized programs can continue to operate after the marketing authorization for the concerned product has been granted but while the decision on reimbursement is still pending. The Law of 25 March 1964 (“Medicines Law”) regulates the use of medicinal products that have not (yet) received a marketing authorization (“compassionate use”, “CU”) and for off-label use (“medical need”,…

Inside EU Life Sciences

Proposed New EU Cyber Rules Introduce More Onerous Requirements and Extend to More Sectors

By Mark Young

January 15, 2021

In addition to releasing the new EU Cybersecurity Strategy before the holidays (see our post here), the Commission published a revised Directive on measures for high common level of cybersecurity across the Union (“NIS2”) and a Directive on the resilience of critical entities (“Critical Entities Resilience Directive”). In this blog post, we summarize key points relating to NIS2, including more onerous security and incident reporting requirements; extending requirements to companies in the food, pharma,…

Inside EU Life Sciences

CJEU Confirms that CBD is Not a Narcotic Drug

By Ellie Handy, Brian Kelly & Marie Doyle-Rossi

November 20, 2020

In a landmark judgment on 19 November 2020, the CJEU ruled in Case C-663/18 that cannabidiol (“CBD”) is not a narcotic drug under the UN Conventions. This is the case even where the CBD is derived from the whole cannabis plant. The ruling provides clarity on the non-controlled status of CBD and the free movement of CBD products within the Union. This is likely to have wide implications for the CBD industry. Background: The case…

Inside EU Life Sciences

European Health Union: European Commission proposes Changes to the Joint Procurement Agreement

By Bart Van Vooren & Katharina Ewert

November 18, 2020

On 11 November 2020, the European Commission has announced a range of proposals to build a European Health Union. The proposed measures reflect on the learnings from the current COVID-19 and previous influenza pandemics and seek to enhance Member States’ preparedness for future health crises, which also includes a greater involvement of the EU. As part of its set of measures, the Commission is proposing to revise the current EU joint procurement framework. Current Joint…

Inside EU Life Sciences

Entry Into Force of Reinforced Anti-gift Rules in France

By Bart Van Vooren & Loïc Waty

October 1, 2020

Today, October 1st 2020, the updated anti-gift scheme in France enters into force. The anti-gift rules impose obligations on pharmaceutical, medical device and cosmetics companies when interacting with healthcare professionals (“HCPs”) and healthcare organizations (“HCOs”) in France. The updated framework was foreseen in the adoption of Ordinance 2017-49 of 19 January 2017 and Decree 2020-730 of 15 June 2020. This blog summarizes the new French rules.…

Inside EU Life Sciences

German court extends legal redress options for pharma companies in the drug pricing and reimbursement system

By Dr. Dr. Adem Koyuncu & Marie Ramm

September 28, 2020

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. The decision therefore significantly broadens the legal redress possibilities of pharmaceutical companies under the German drug pricing and reimbursement regulation.…

Inside EU Life Sciences

Brexit: UK Guidance on Regulation of Medical Devices from 1 January 2021

By Sarah Cowlishaw & Katharina Ewert

September 3, 2020

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published Guidance on the regulation of medical devices from 1 January 2021 (the “Guidance”). It discusses the regulatory requirements that apply to medical devices after the end of the Brexit transitional period under the EU-UK Withdrawal Agreement. In summary: From 1 January 2021, different rules will apply to medical devices placed on the market in Great Britain (e., England, Wales and Scotland) and those placed…

Inside EU Life Sciences

New Licensing Regulations to Import Agricultural Products into the EU: What Traders Should Know to Avoid Missing Quota Allocations in 2021

By Cándido García Molyneux & Paul Mertenskötter

August 29, 2020

As of January 2021, many imports and exports of agricultural products covered by EU tariff quotas will be subject to the new licensing rules of Commission Delegated Regulation (EU) 2020/760 (“Delegated Regulation”) and Commission Implementing Regulation (EU) 2020/761 (“Implementing Regulation”) (together, “Licensing Regulations” or “Regulations”). The new Regulations introduce significant changes to – and are likely to disrupt – the trade of a wide variety of food and feed products, including beef, pork, poultry, sugar,…

Inside EU Life Sciences

Updates on Legal Developments in the EU Life Sciences Industry

Blog Authors

German Patent Law Reform Would Introduce “Disproportionality” Defence

EU Adopts Export Authorization Scheme for COVID-19 Vaccines and their Active Substances

Belgium Amends Compassionate Use and Medical Need Program Rules to Expand Access

Proposed New EU Cyber Rules Introduce More Onerous Requirements and Extend to More Sectors

CJEU Confirms that CBD is Not a Narcotic Drug

European Health Union: European Commission proposes Changes to the Joint Procurement Agreement

Entry Into Force of Reinforced Anti-gift Rules in France

German court extends legal redress options for pharma companies in the drug pricing and reimbursement system

Brexit: UK Guidance on Regulation of Medical Devices from 1 January 2021

New Licensing Regulations to Import Agricultural Products into the EU: What Traders Should Know to Avoid Missing Quota Allocations in 2021

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