Life Science Update: April 2024
Welcome to this edition of Kromann Reumert's Life Science Update. In the following, we provide an overview of recent legal updates that will have a bearing on the life science industry across Europe, with particular focus on Denmark.
Denmark
Draft bill on mandatory safety stocks of critical medicinal products and weekly reporting obligations
On 22 March 2024, a public consultation opened by the Danish Ministry of the Interior and Health on a draft bill to amend the Danish Medicines Act and draft executive orders on mandatory safety stocks and weekly reporting obligations regarding critical medicinal products ended.
Intended to enter into force on 1 July 2024, the draft rules aim at ensuring the supply of critical medicinal products in case of short-term supply shortages to safeguard patients' well-being. Further, the suggested stocks are to enable the Danish Medicines Agency (DMA) and other stakeholders to take timely action to avoid long-lasting supply shortages that cannot be remedied by the stocks.
The draft bill and executive orders apply to companies that market critical medicinal products listed in one of the executive orders for use in primary health care. The proposed key elements are the following:
- Mandatory stocks: Companies will be required to keep a safety stock of critical medicinal products. The size of the stock must correspond to eight weeks of the company's historical sale of the medicinal products in question at packaging level to pharmacies and in retail. However, it may be possible to exempt from these rules, e.g. if a company has a very small market share with respect to the medicinal product in question or if the medicinal product has a short shelf-life. The stock must be kept in Denmark, but exceptions e.g. to keep the stock in another EU/EEA country may be made. The obligation to keep stock will be suspended if the company reports supply shortages, so that the company may use the stock to supply the market.
- Weekly reporting obligations: Companies will have an obligation to report their stockpile to the DMA electronically on a weekly basis.
A transitional period of minimum three months will apply once the new rules enter into force and in case new medicinal products are added to the list of products covered by the rules.
Various industry stakeholders, e.g. the Danish Chamber of Commerce (Dansk Erhverv) and the Danish Association of the Pharmaceutical Industry (Lif) as well as pharmaceutical companies, have publicly criticised the draft bill as they fear that it will lead to more waste of medicines and increased medicine prices.
The draft bill can be accessed here (in Danish), the draft executive orders can be accessed here and here (both in Danish) and the Danish Medicines Agency's announcement can be accessed here (in Danish).
Proposal to improve recruitment of foreign healthcare professionals from third countries
A public consultation opened by the Danish Ministry of the Interior and Health on a draft bill to amend the Dansh Act on Authorisation of Healthcare Professionals and Healthcare Business (the Authorisation Act) and the Danish Aliens Act ended on 19 March 2024.
The draft bill - which is intended to enter into force on 1 July 2024 - implements a number of initiatives to improve the opportunities for recruitment of foreign healthcare professionals from third countries that were agreed upon in a political agreement dated 24 January 2024.
One of the proposed key amendments to the Authorisation Act is the introduction of a "shortcut authorisation process" for particularly sought-after healthcare professionals, i.e. healthcare professionals that have entered into an agreement on or have a concrete offer of employment for adaption and training purposes (in Danish: evalueringsansættelse) with a Danish employer. The shortcut authorisation process will enable such professionals to begin their employment immediately after the Danish Patient Safety Authority (DPSA) has approved their formal qualifications, i.e. before the remaining requirements for authorisation have been fulfilled (which they, however, must be in parallel with the employment). Certain additional requirements with respect to the place of work and the employment's length will also apply.
Another proposed key amendment to the Authorisation Act is the modification of the assessment of healthcare professionals' educational level in the authorisation process (instead of solely assessing the professionals' fundamental education, the DPSA will assess the professionals' overall educational level), along with the possibility of compensation for insufficient clinical hours (internship).
The proposed amendments to the Aliens Act consist of an expansion of the positive list for skilled workers (a scheme of skilled professions experiencing a shortage of qualified professionals based on which workers may apply for residence and work permits) to include social and healthcare assistants (with a quota of 1,000 residence and work permits), introduction of an authorisation residence scheme for particularly sought-after healthcare professionals, exemption from the general work permit requirement during the authorisation residence and adjustments of the rules on authorisation residence, including extended authorisation residence for medical doctors and dentists as well as the possibility of job-seeking residence of 6 months after the authorisation has been obtained.
The draft bill can be accessed here (in Danish).
EU
MEPs adopt compromise amendments to reform of European pharmaceutical legislation
The European Commission presented a comprehensive proposal to reform the EU's pharmaceutical legislation, including proposals for a new directive and a new regulation, on 26 April 2023. Read more about the reform in our December 2023 Life Science Update.
In a press release dated 19 March 2024, the European Parliament announced that the Committee on the Environment, Public Health and Food Safety (ENVI) adopted its compromise amendments with proposed improvements to the new directive and the new regulation. The Danish Association of the Pharmaceutical Industry (Lif) generally welcomes the amendments stating that they contribute to a positive progress in the revision of the rules as they to a large extent meet the concerns and suggestions that the industry has raised in the debate.
The ENVI Committee proposes to introduce a minimum regulatory data protection period of 7.5 years from the grant of marketing authorisation (which is a reduction of the current minimum protection period of 8 years) with the possibility of additional periods of data protection if (i) the product addresses an unmet medical need (+12 months), (ii) comparative clinical trials are conducted (+6 months), and (iii) a significant share of the product's research and development takes place in the EU at least in part in collaboration with public EU entities (+6 months), however capped at 8.5 years in total.
Further, the ENVI Committee proposes to introduce a possibility of a one-time 12-month extension of the 2-year market protection that will apply after the expiry of the data protection. For orphan drugs, the ENVI Committee proposes to introduce up to 11 years market exclusivity for orphan drugs if they address a "high unmet medical need".
Moreover, the ENVI Committee proposes to introduce several measures to step up the fight against antimicrobial resistance (e.g. incentives to boost research and development and encourage investment in antimicrobials as well as stricter requirements for the use of antimicrobials), strengthened requirements for environmental risk assessment and increased independence for EU health emergency body.
The compromise amendments to the new directive and the new regulation will be debated and voted at the Parliament's Plenary Session on 10-11 April 2024 and will be subject to further discussions with the Commission and the Council of the European Union.
Access the European Parliament's press release on the subject here and Lif's comments here (in Danish).
European Parliament and Council agree on European Health Data Space
On 15 March 2024, the European Parliament and the Council of the European Union reached a provisional political agreement on the creation of a European Health Data Space (EHDS) aiming at easing access to personal health data and boosting secure sharing for the public interest.
In terms of primary use, the EHDS will enable patients to access their personal health data electronically across the EU's different healthcare system (and to download their electronic health record which will include patient summary, electronic prescriptions, medical imagery and laboratory results) and healthcare professionals to access their patients' health data when strictly needed for treatment. Patients will be informed each time their data is accessed, and they will have the right to request or correct incorrect data and to object to healthcare professionals' access to their data, except if deemed necessary for protecting the vital interests of the patient or another person.
As to secondary use, the EHDS will allow anonymised or pseudonymised health data to be shared for public interest purposes, e.g. research, innovation, policy-making, education and patient safety. Patients will, however, be able to opt out of such use with certain exceptions. Sharing of data for advertising, assessing insurance requests or decisions on labour markets, lending conditions and other types of discrimination or profiling will be prohibited.
National data protection authorities will be tasked with monitoring the enforcement of health data access rights and they will be empowered to issue fines.
The provisional agreement needs to be formally adopted by both EU institutions before it can enter into law.
Access the European Parliament's press release here and the procedure file here.
European Medicines Agency releases major update of SME user guide
On 23 January 2024, the European Medicines Agency (EMA) released a major revision of its user guide for micro, small and medium-sized enterprises (SMEs) in the pharmaceutical sector.
The user guide has been revised to reflect major changes to the EU legislative framework for medicines for human and veterinary use and now offers comprehensive information on said legislation, outlining requirements for the development and authorisation of medicines.
The guide now provides an overview of the Clinical Trials Regulation and Clinical Trials Information System (CTIS) (new section 4.4) and the Medical Devices Regulation (new Section 4.8).
Further, the guide has been expanded to include (sub-)sections on IT systems (section 1.3), borderline products (products with regulatory framework uncertainty, section 3.6), environmental risk assessment (section 4.2.4), big data (section 4.3.6), 'EU-M4all' (access to high-priority medicines for patients outside of the EU, section 6.16) and 'OPEN' initiative (information on EMA collaboration with non-EU regulators in the scientific evaluation of certain medicines, section 6.17).
The updated user guide for SME can be accessed here, and the European Medicines Agency's press release can be found here.
Contact
