On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog
Continue Reading Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical DevicesSoon a new global tax on products developed from “digital information” from biological materials? 5 key takeaways for companies from recent UN negotiations
Photo: View from the business delegation to the negotiations in Montreal, of which Covington were part.
On August 16th, 2024, in Montreal, Canada, parties to the Convention on Biological Diversity (“CBD”) agreed on the draft text (“Draft decision”) for the operationalization of the Global
Continue Reading Soon a new global tax on products developed from “digital information” from biological materials? 5 key takeaways for companies from recent UN negotiationsGermany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectations
Last week, on 4 July 2024, the German Parliament (Bundestag) has passed significant changes to the country’s drug pricing and reimbursement laws. Just six months after the German Federal Health Ministry (BMG) presented a first draft bill for a “Medical Research Act” (Medizinforschungsgesetz or MFG), the German
Continue Reading Germany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectationsGermany prepares new National Strategy for Gene and Cell Therapies
1. Background
Gene and cell therapies are on the rise. On June 12, 2024, the German Federal Government was handed the strategy paper for a National Strategy for Gene and Cell Therapies. The paper is intended to serve as a basis for policymaking to give Germany a leading
Continue Reading Germany prepares new National Strategy for Gene and Cell TherapiesEU Talking Life Sciences Audiocast: Green Claims – Recent Developments in EU Regulation and Enforcement
In this episode of Covington’s Life Sciences Audiocast, Seán Finan discuss some important recent developments in the regulation of sustainability and green claims and labelling schemes, and the ever-increasing enforcement risk that comes with greenwashing.
UK MHRA Announces Intention To Recognize Certain International Approvals For Certain Medical Devices
On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published a statement of policy intent for UK recognition of international regulatory approvals of certain medical devices (the “Statement”). The Statement follows the Government response to the 2021 consultation on the future regulation of medical devices in the UK that details an intention to introduce alternative routes to market for medical devices, such as utilizing approvals from other countries and Medical Device Single Audit Program (“MDSAP”) certificates, in addition to the current UK Conformity Assessed (“UKCA”) marking process.
The MHRA has already taken similar steps in the medicines space, adopting a new International Recognition Procedure (“IRP”) in January 2024.
In relation to devices, the Statement applies to certain medical devices placed on the market in Great Britain. For relevant devices, the MHRA proposes to recognize foreign approvals from regulators in Australia, Canada, EU/EEA and USA (which is a smaller number of acceptable regulators than under the MHRA’s IRP for medicines). The Statement expressly excludes a number of medical devices from international recognition, including software as a medical device (“SaMD”) (including AI as a medical device (“AIaMD”)) and companion diagnostic products approved via US 510(k) (a route which relies on equivalence to a predicate).
The proposed framework is a draft and the final version is expected to come into force in 2025 at the same time as future core regulations. It also remains the government’s intention to introduce transitional arrangements for UKCA marked devices at the same time.
Continue Reading UK MHRA Announces Intention To Recognize Certain International Approvals For Certain Medical DevicesEU Talking Life Sciences Audiocast: EU Pharma Law Review – Focus on Incentives
In this episode of Covington’s Life Sciences Audiocast, Marie Doyle-Rossi, Anna Wawrzyniak, and Valeria Sturla discuss the position adopted by the European Parliament on 10 April 2024 on the Commission proposal to reform the core EU pharmaceutical legislation.
Parliament’s position comes less than a year since the
Continue Reading EU Talking Life Sciences Audiocast: EU Pharma Law Review – Focus on Incentives
MHRA Outlines New Strategic Approach to Artificial Intelligence
On April 30, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) outlined its strategic approach (“Approach”) to artificial intelligence (“AI”). The Approach is a response to the UK Government’s white paper: a pro-innovation approach to AI regulation and subsequent Secretary of State letter of 1 February 2024, and is the culmination of 12 months’ work by the MHRA to ensure the risks of AI are appropriately balanced with the potential transformative impact of AI in healthcare.
AI in Healthcare
AI has the potential to revolutionize the healthcare sector and improve health outcomes at every stage of healthcare provision – from preventative care through to diagnosis and treatment. AI can help in research and development by strengthening outcomes of clinical trials, as well as being used to improve the clinical care of patients by personalizing care, improving diagnosis and treatment, enhancing the delivery of care and health system efficiency, and supplementing healthcare professionals’ knowledge, skills and competencies.
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European Parliament adopts its Position on EU Pharma Law Review: 8 Key Takeaways for Industry
On 10 April 2024, the European Parliament adopted its position on the Commission proposal to reform the core EU pharmaceutical legislation (see here and here). In doing so, the European Parliament has met its ambitious timeline to adopt its position before the upcoming Parliamentary elections and marks a significant step in the legislative process.
Parliament’s position comes less than a year since the Commission published its proposal, which consists of a new directive replacing Directive 2001/83/EC and a new master regulation replacing Regulation 726/2004, which will also consolidate the orphan and pediatric medicines regulations (see our prior EU Pharma Legislation Review blog series). Many of Parliament’s amendments to the Commission proposal will be seen as improvements by the innovative industry, but there remain challenges and unresolved questions.
We provide below the top 8 takeaways for industry to consider during the next phase of the legislative process, which is a detailed review by the Council.
Continue Reading European Parliament adopts its Position on EU Pharma Law Review: 8 Key Takeaways for IndustryNew EU Wastewater Treatment Fees on Producers of Pharmaceutical and Cosmetic Products
Today, the European Parliament approved a new (recast) Urban Wastewater Treatment Directive (“UWWTD”) that will impose new additional costs on producers marketing pharmaceutical and cosmetic products in the European Economic Area by the end of 2027. Some studies suggest that the costs that producers would have to collectively pay could
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