INVESTING IN HEALTHCARE & LIFE SCIENCES

Austria

At a glance:

Austria has introduced new laws on assisted suicide for seriously ill persons.

• More than 99% of the Austrian population is medically insured in the statutory health insurance system.
• The Austrian Pharmacy Act recently was amended to more clearly reflect the free choice of pharmacy.
• The Austrian Medical Devices Act 2021 is now fully in force for both medical and in vitro diagnostic devices.
• Telemedicine and teleconsultation are permissible in Austria if certain requirements are met.
• Companies in the healthcare sector may qualify as critical infrastructure within the meaning of the Austrian Investment Control Act.

Denmark

At a glance:

Denmark is pioneering a life sciences industry strategy with 38 initiatives to enhance research and development.

• Draft legislation aims to ease the health research process and expand patients’ and test subjects’ right of self-determination.
• The Danish public healthcare system operates across three levels: the state, the regions and the municipalities.
• Clinical trials of medical devices in Denmark require approval from both the Danish Medicines Agency and a research ethics committee.
• If a medical device is made available to end users or patients, its labeling and user manuals must be in Danish.
• Denmark is viewed as a leader in telemedicine, with unique nationwide projects.

France

At a glance:

France is the first European country to regulate healthcare influencers’ activity on social networks.

• A new law requires dental, ophthalmological and orthoptic health centers to obtain approval from the Regional Health Agencies prior to opening.
• France introduced early coverage for digital medical devices for therapeutic use and remote medical monitoring.
• The French Data Protection Authority announced the creation of a department dedicated to artificial intelligence.
• The French High Health Authority published good professional practice guidelines and assessment methods for teleconsultation companies.
• France became the first EU Member State to reimburse remote medical monitoring solutions that provide clinical benefits or improve the organization of care.

Germany

At a glance:

Germany is undergoing comprehensive hospital reform.

• The Federal Ministry of Health recently issued two draft acts proposing a digitization strategy.
• The Act to Combat Supply Shortages and Improve the Supply of Medicines amended several laws affecting pharmaceutical market access, pricing and reimbursement.
• The Federal Council formally requested that the Federal Government issue draft legislation introducing labelling obligations, a registry and other requirements for medical care centers.
• While Germany has no standalone telemedicine regulatory regime, telemedicine services are generally permissible if they are in accordance with medical guidelines and the state of scientific knowledge.
• Foreign investment in the German health sector may be subject to notification obligations and clearance by the Federal Ministry for Economic Affairs and Climate Action.

Italy

At a glance:

Italy is pouring more than EUR 15 billion into the public health sector.

• The National Recovery and Resilience Plan aims to enhance the Italian healthcare ecosystem in terms of innovation, digitization and effectiveness of care.
• Italy’s new payback mechanism is subject to ongoing discussion among the regulatory authorities, industry associations and medical device companies.
• New legislation aims to simplify and speed up the procurement process for public healthcare facilities.
• While Italy has no specific national regulations for SaMD or AI in medical devices, discussions are underway regarding potential prescription or reimbursement of digital therapeutics.
• A national platform for telemedicine services is expected to be operational by the end of 2023.

Netherlands

At a glance:

The Netherlands is legislating on ethical business operations for care providers and online prescriptions.

• An amendment to the Act on Public Health would establish a National Facility on Infection Control.
• The Minister of Health, Welfare and Sport withdrew his proposed reform of the Drug Reimbursement System and will propose alternative measures in 2024.
• The Netherlands has developed good professional conduct guidelines related to AI in the medical sector.
• The government is encouraging the healthcare sector to expand telehealth.
• Healthcare mergers are no longer subject to lowered turnover thresholds for notification to the Dutch Competition Authority.

Poland

At a glance:

Poland is tightening up the law on advertising medical devices.

• In Poland there are currently no specific regulations applicable to SaMD and AI.
• Solutions based on AI are becoming more popular and are increasingly covered by reimbursement.
• Telemedicine healthcare providers must be entered in a public register of healthcare providers.
• The Polish government is scrutinizing e-platforms that offer patients prescriptions without substantive physician review.
• A proposed amendment to the Pharmaceutical Law would significantly limit takeovers of pharmacies in Poland by non-pharmacists.

Spain

At a glance:

Spain is seeing rising demand for precision medicine, and genetic testing is growing.

• Spain’s new medicines law is expected to be approved soon.
• Complete reform of Spain’s regulations on promotional practices for drugs and medical devices is also expected shortly.
• Pressure over prices for new drugs could lead to shortages in specific drugs, including orphan drugs.
• A new Royal Decree on medical devices was recently approved to supplement the EU MDR.
• Spanish law prevents anyone with the ability to prescribe or authorize the dispensing of drugs from having a direct economic interest in marketing drugs or medical devices.

Switzerland

At a glance:

Switzerland is ushering in a new regime on human genetic testing, as well as a liberalized approach to medical cannabis use.

• The Federal Council plans to make the electronic patient record an instrument of mandatory health insurance.
• Swiss medical device regulations are harmonized with the corresponding EU/EEA regulatory framework.
• Switzerland is participating in the negotiations for an international convention on AI as a member of the European Committee on AI.
• Telemedicine is subject to the same rules as in-person healthcare.
• There are currently no foreign investment control restrictions in the Swiss healthcare sector.

United Kingdom

At a glance:

The United Kingdom is preparing to accelerate the clinical trial process, becoming a hub for innovation.

• The UK government is finalizing new procurement legislation and a “provider service regime” applicable to NHS healthcare services.
• Transitional post-Brexit provisions allow the United Kingdom to authorize medicines on a fast-track process in reliance upon European Medicines Agency decisions.
• With the Voluntary Scheme for Branded Medicines Pricing and Access expiring at the end of 2023, some pharmaceutical industry associations are calling for a new approach emphasizing investment and growth.
• The Medicines and Healthcare Products Regulatory Agency intends to develop a framework for medical devices that would go into effect in 2025.
• While the United Kingdom currently has no AI-specific legislation, the government aims to develop a pro-innovation regulatory approach.

United States

At a glance:

The United States is focusing on drug pricing negotiation and health equity.

• Unlike European jurisdictions, the United States has a significant market for private reimbursement of healthcare services.
• Currently, 43 states and the District of Columbia have private payor laws governing telehealth.
• The US Food and Drug Administration is considering adapting its regulatory framework to promote the development of safe and effective medical devices that use advanced AI algorithms.
• Although the COVID-19 public health emergency has ended, certain Medicare reimbursement flexibilities related to telehealth are extended through December 31, 2024.
• The US Department of Justice and the Office of Inspector General have increased enforcement actions targeting fraud and abuse in the telehealth sector.