Foreign investment control: Under the National Security and Investment Law of 2021, a new autonomous regime has been introduced for the review and intervention in acquisitions in certain sensitive sectors of the economy. The law comes into force in 2022 and introduces a mandatory regime for mandatory sectors, including advanced robotics, artificial intelligence, synthetic biology
NHS Legislative changes: In 2021, the UK government introduced the Health and Care Bill, which includes a series of changes to NHS bodies, the introduction of integrated care boards, changes to the pricing of health services and the purchase of NHS services. Separate regulations should be published for the selection of NHS service providers.
Drugs and Medical Devices Act: In 2021, the government introduced the Medicines and Medical Devices Act. The new law is framework legislation that gives the Secretary of State broad powers to adopt a new regulatory framework for drugs and medical devices. In September 2021, the UK government published a consultation on future medical device regulation outlining proposed options for a new regulatory framework.
Brexit-related changes: On January 1, 2021, the United Kingdom left the European Union, inaugurating a new legislative framework for the United Kingdom. Most European legislation has been transferred to autonomous UK legislation. The impact of Brexit has significantly affected the health and life sciences services, particularly with regard to recruitment, the marketing of drugs and medical devices, customs and tariff changes, the appointment of authorized representatives and the import and supply chain.
Supply: On December 15, 2020, the UK government published a Green Paper on Public Procurement outlining important changes to public procurement law and deviations from the EU Public Procurement Directive. This remains in consultation.
Data protection: Although the EU GDPR was kept in the UK as a stand-alone data protection law after Brexit, the UK government released a consultation version for international data transfers in August. In September, the government also published a consultation on the future data protection regime for the UK.
Foreign investment control: Under the German foreign investment control regime, the Federal Ministry of Economic Affairs and Energy may, under certain circumstances, examine whether foreign investments in the health and life sciences sector are likely affect public order or security. Over the past few years, the regime has been and continues to be subject to significant changes. Based on recent reforms, foreign investments in health infrastructure of particular public interest, such as large hospitals or certain manufacturers of drugs and medical devices, may need to be notified and authorized by the ministry before the close of the process. transaction. A further tightening of the regime is expected soon.
Denunciation: Germany is currently implementing the European directive on whistleblowers. The Federal Ministry of Justice has submitted a corresponding bill that goes far beyond the requirements of the Directive and is the subject of controversial discussions within the German government and among experts. The directive is due to be implemented by December 17, 2021. Germany could struggle to meet this deadline due to federal elections and the upcoming new legislature.
IT security guidelines: The Federal Association of Licensed Physicians has published an IT security directive for medical practices which becomes fully binding as of January 1, 2022. The directive provides technical and organizational standards that must be observed by medical practices, including medical care centers. These standards vary depending on the size of the respective practice.
Clinical tests: The German legislator is in the process of amending the Federal Law on Medicines (Arzneimittelgesetz) and the Federal Ordinance on the Manufacture of Medicines and Active Ingredients (Arzneimittel- und Wirkstoffherstellungsverordnung) under the Clinical Trials Regulation (Regulation (EU) No. 536/2014) which is expected to come into force on January 31, 2022.
Supply Chain: The Federal Law on Supply Chain Obligations (Lieferkettensorgfaltspflichtengesetz) will likely enter into force on January 1, 2023. It sets out specific due diligence duties for large companies with the aim of respecting human rights and environmental standards globally. Once into force, the new law will likely have substantial implications for global life science companies.
Telemedecine : New laws on telemedicine and in particular telesurveillance should be adopted in 2022, broadening the scope of what is currently authorized.
Medical Cannabis: A medical cannabis experiment started in March 2021 to assess the advisability of generalizing the use of cannabis-based drugs in France. The results are expected in September 2023.
Bioethics and reproduction: A new bioethics law entered into force on August 2, 2021. It extended medically assisted procreation to women in couples and unmarried women and gave new rights to children born from this procedure. It contained other provisions, including self-preservation of gametes for non-medical reasons, embryo research and stem cell research.
Medical devices and clinical trials: Recent changes in the legislation on medical devices and clinical trials on medicinal products for human use may bring unexpected challenges to French operators and researchers.
COVID-19[female[feminine: Many laws have been passed during the COVID-19 pandemic and will likely be the subject of further discussions and amendments.