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 Scholz from the Social Democrats will replace the Merkel administration and will be in office for four years. On November 24, 2021, the new coalition has presented their coalition agreement with their plans for the next 4 years. The agreement needs to be approved by the respective party committees and it is expected that all three parties will approve it.

Continue Reading New German Government plans significant changes with Impact on the Healthcare, Life Sciences and Food Sector

Between 29 November and 1 December 2021, all member states of the World Health Organization (WHO) will convene for an extraordinary session of the World Health Assembly (WHA).  There is only one agenda item: whether or not to commence negotiations towards a legally binding, global instrument on pandemic preparedness and response.  Since it was first proposed by the European Union (EU) in November 2020, significant momentum has built towards some kind of International Pandemic Treaty (IPT).  The project is currently backed by the EU and more than 25 countries, though sceptics include the U.S., Russia, Brazil and China.

The IPT will be directly relevant to all pharmaceutical companies developing medical countermeasures (e.g. vaccines, diagnostics, and therapeutics) to most infectious diseases with epidemic or pandemic potential.  This blog summarizes key points that pharmaceutical companies should be aware of.

Continue Reading Negotiations on a ‘Global Pandemic Treaty’ – What should Pharmaceutical Companies Expect?

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 and ML have the “potential to transform health care” through their ability to analyse vast amounts of data and learn from real-world use.  However, these technologies also pose unique challenges, given their complexity and the constantly evolving, data-driven nature of their development.  The Regulators formed the guiding principles to “help promote safe, effective, and high-quality medical devices that use . . . AI/ML” and to “cultivate future growth” in this fast paced field.

The Regulators predict that the guiding principles could be used to: (i) adopt good practices from other sectors; (ii) tailor these practices to the medical technology/healthcare sector; and (iii) create new practices specific to the medical technology/healthcare sector.  The Regulators expect these joint principles to inform broader international engagements as well.

Continue Reading U.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles” for Good Machine Learning Practices (“GMLP”) for Medical Devices

The Medicines & Healthcare products Regulatory Agency (“MHRA”) has published a “Consultation on the future regulation of medical devices in the United Kingdom” (the “Consultation”), which will run until 25 November 2021.  The consultation sets out proposed changes to the UK medical device regulatory framework with the aim to “develop a world-leading future regime for medical devices that prioritises patient safety while fostering innovation.

Separately, the MHRA has published a work programme on software and AI as a medical device to deliver a regulatory framework that makes sure that the UK is the home of responsible innovation for medical device software.  Any legislative change proposed by the work programme will build upon the wider reforms to medical device regulation being consulted upon as a part of the Consultation.

The MHRA intends that any amendments to the UK medical device framework will come into force in July 2023.  This aligns with the date when UKCA marking will become mandatory in the UK and when EU CE marks will no longer be recognized.  The MHRA has made clear that it will provide adequate transition periods before adopting any new requirements.

All interested parties are encouraged to contribute to shaping the future regulation of medical devices in the UK by responding to the MHRA’s consultation before the deadline (25 November 2021).

Continue Reading Consultation on the Future Regulation of Medical Devices in the UK, including Work Programme for Software and AI Medical Devices

Following the UK’s departure from the EU, the UK Government has been exploring ways to leverage its new regulatory freedoms. In particular, the life sciences sector has been a key Government priority. As early as January 2021, for example, the Government granted the MHRA powers to fast-track approvals for innovative medicines. More recently, two reports from Westminster bodies have proposed a new regulatory regime for so-called “nutraceuticals” (products that are part drug, part nutritional) to encourage investment.

Continue Reading Growing calls for separate Nutraceutical regulation in the UK

On 6 May 2021, the European Food Safety Authority (“EFSA”) published its updated safety assessment on titanium dioxide as a food additive (E171). EFSA examined new evidence on nanoparticles and found that there was uncertainty about E171’s ability to accumulate in the body and damage genetic material in cells; i.e. genotoxicity. The agency could not calculate an Acceptable Daily Intake (“ADI”), nor could it determine a safe cut-off value for particle size and distribution. On that basis, it could not confirm the safety of E171 in food. However, since it found no evidence of acute toxicity, an immediate ban is not warranted. France previously initiated a national ban in 2019/2020; following EFSA’s revised opinion, the EU is likely to adopt an EU-wide ban early 2022. In this blog, we briefly review the planned EU-level response and the developments in the Netherlands, Germany and the UK.

Continue Reading EU Plans Ban on Titanium Dioxide in Food

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 24, 2021, the World Health Organization (WHO) announced it singed an MoU with Switzerland to host the WHO’s first BioHub Facility, which is part of the new BioHub System first announced at the World Health Assembly in November 2020.

The stated purpose of the WHO BioHub is to set up a system that guarantees the timely sharing of biological material (e.g., clinical samples, specimens, isolates, cultures) for emerging pathogens, so as to ensure their faster identification and characterization and enable risk assessments and the rapid development of countermeasures (e.g., vaccines, diagnostics and therapeutics).

Continue Reading WHO Launches Global BioHub for Pathogen Sharing

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 6 May 2021, the European Commission published its “EU Strategy on COVID-19 Therapeutics” (the “Strategy”).  With the vaccination programme now under way, the EU is shifting focus towards the development, approval and procurement of COVID-19 therapeutic products.  The Commission intends to build on the experience from the EU vaccines strategy.  In particular, the aim is to have three new therapeutics available by October 2021 and possibly two further products by the end of the year.

The Strategy touches on a number of key areas for both biotechnology and pharmaceutical companies operating in the space: Continue Reading European Commission outlines Strategy on COVID-19 Therapeutics