The Danish Life Science Council presents 12 recommendations for Denmark's new life science strategy
With the current Danish life science strategy set to expire by the end of 2023, the Danish Government requested the Danish Life Science Council to provide recommendations for the new life science strategy to address key challenges in the sector. These recommendations aim to strengthen Denmark's position as the leading life science nation in Europe by ensuring a long-term focus towards 2030.
The recommendations are based on four key themes: (1) improved integration of innovation in the healthcare sector through public-private collaborations, (2) a stronger growth foundation in the life science industry, (3) international collaboration and health diplomacy, and (4) framework conditions for the life science production and investments in Denmark.
Based on these four key themes, the Danish Life Science Council presented the following 12 recommendations for Denmark's new life science strategy on 11 December 2023:
The 12 recommendations
1. Promoting innovation in the healthcare sector
The Danish Life Science Council recommends that innovation in the Danish healthcare system be highly prioritised to ensure patient access to innovative medicines and medical devices. The council emphasises the importance of systematically developing, testing, implementing, and scaling labour-liberating healthcare solutions in close collaboration with private entities.
2. Prioritising clinical research
Denmark should prioritise and conduct more clinical research as an integrated part of patient treatment.
3. Fulfilling the potential of Danish health data
The potential of Danish health data and a national health data infrastructure should be realised.
4. Enhancing the improvement of technology transfer
The transfer of technology from universities and hospitals to entrepreneurs and companies should be improved.
5. Accessible funding for companies
Companies should have access to coherent funding opportunities throughout the entire value chain.
6. Improving collaborations
The framework for collaborations between research environments, the healthcare system and companies should be improved.
7. Strengthening strategic export promotion
Denmark's efforts in strategic export promotion for healthcare solutions should be strengthened.
8. Competitive regulatory framework
The Danish representation of interests in the EU should be improved to enhance Europe's appeal as a leading life science region by ensuring a competitive regulatory framework and international market access.
9. Targeting health diplomacy and international collaboration
Health diplomacy and international collaboration among authorities should be strengthened and targeted to support the Danish life science sector and to attract international life science companies to Denmark.
10. Strengthening the Danish framework for production
The framework for Denmark as a life science production country should be improved, inter alia through identifying industrial zones suitable for life science production and more flexible administrative approval processes for permits.
11. Focusing on training and attracting skilled workforce
The framework for training and attracting future employees to the life science industry should support the achievement of growth ambitions.
12. Continued focus on sector framework conditions
The continued focus on improving the sector framework conditions is a prerequisite for achieving the growth ambitions.
The new life science strategy for 2024 - 2030 is expected to be presented in the spring of 2024.
The Danish Life Science Council's 12 recommendations can be accessed here (in Danish).
The 12 recommendations presented by the Danish Life Science Council have been well received and applauded by the Danish Association of the Pharmaceutical Industry and Medicoindustrien (the Danish industry association for medical device companies). The 12 recommendations have also been welcomed by the Danish Minister for Industry, Business and Financial Affairs, the Danish Minister for the Interior and Health and the Danish Minister for the Ministry of Higher Education and Science.
Access the press release of Danish Association of the Pharmaceutical Industry here (in Danish), Medicoindustrien's press release here (in Danish) and the press release of the Ministry of Industry, Business and Financial Affairs here (in Danish)
EU
Revision of the EU pharmaceutical legislation - overview and status
On 26 April 2023, the European Commission presented the most extensive proposal in over twenty years to reform the EU's pharmaceutical legislation (the "Reform"). The highly anticipated Reform is a result of some of the flagship initiatives set out in the European Commission's Pharmaceutical Strategy for Europe that was adopted on 25 November 2020.
The European Commission's overall purpose with the Reform is to make medicines more available, accessible and affordable while also aiming to support innovation and boost competitiveness of EU's pharmaceutical industry. The Reform is extensive and entails significant changes to the existing pharmaceutical EU legislative framework, including changes to the regulatory data protection for innovators, measures to prevent and enhance security of supply of medicines, introduction of a regulatory sandbox and transferable data exclusivity vouchers for antimicrobials.
The Reform can be accessed here, and the European Commission's Pharmaceutical Strategy for Europe can be found here.
The Reform
The Reform seeks to modernise and simplify the existing pharmaceutical EU legislative framework. It consists of the following two legislative proposals, which revise and replace the existing general pharmaceutical legislation (Directive 2001/83/EC and Regulation (EC) No 726/2004) and the specific pharmaceutical legislation on medicines for children (Regulation (EC) No 1901/2006) and for rare diseases (Regulation (EC) No 141/2000/EC):
- A new Directive which lays down rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of medicinal products for human use at EU and national level. The Directive repeals and replaces Directive 2001/83/EC and Directive 2009/35/EC and incorporates relevant parts of Regulation (EC) No 1901/2006.
- A new Regulation which lays down procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human use as well as rules governing the European Medicines Agency. The Regulation repeals and replaces Regulation (EC) No 726/2004 and Regulation (EC) No 141/2000/EC, repeals and incorporates relevant parts of Regulation (EC) No 1901/2006, and amends Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014.
In addition to the two legislative proposals, the Commission has proposed a Council Recommendation on intensifying EU actions to combat antimicrobial resistance (AMR) to provide solutions for human, animal and environmental health.
Lastly, the two legislative proposals and the Council Recommendation are accompanied by a Communication from the European Commission that addresses the Reform of the pharmaceutical legislation and the measures to combat AMR.
According to the European Commission, the Reform addresses the entire lifecycle of medicines to achieve the following main objectives in an effort to strike the right balance between incentivising innovation and increasing access and affordability of medicines.
Varying views from stakeholders
Stakeholders from the pharmaceutical sector have voiced different views on the Reform. While some, such as the European Public Health Alliance and European Patients Forum, welcome the Reform, others, the European Federation of Pharmaceutical Industries and Associations, have raised serious concerns over its negative implications on innovation and competitiveness within the EU's pharmaceutical industry.
Access the European Public Health Alliance's press release here, the European Patients Forum's press release here, and the European Federation of Pharmaceutical Industries and Associations' press release here.
The Danish Government's preliminary position
The Danish Government communicated its preliminary position on the Reform in the Ministry of the Interior and Health's memorandum of 28 September 2023 to the European Affairs Committee of the Danish Parliament. In addition to the Danish Government's preliminary position, the memorandum also provides, inter alia, a description of the Reform, consequences of the Reform, and consultation responses from relevant stakeholders.
The Danish Government supports the main objectives of the Reform and emphaizes the importance of striking the right balance between, on the one hand, providing an attractive and competitive framework for research, development, and production of medicines in the EU and, on the other, promoting access to affordable medicines and strengthening the security of supply of medicines.
The Danish Government expresses serious concern about the proposed reduction of the general regulatory data protection period, which is proposed to be reduced from 8 years to 6 years (with conditioned additional regulatory data protection periods), as it could weaken the incentive to develop new medicines, result in less new medicines, and impair EU's competitiveness and the framework for the research-based pharmaceutical industry, which is important for the Danish and European economy. The Danish Government further expresses that an alternative solution should be found and emphasizes the importance of providing a good framework for small and medium sized companies.
The Danish Government welcomes a number of the initiatives, including the Reform's measures to (i) support the development of medicines for unmet medical needs, rare diseases and children, (ii) incentivise development of new antimicrobial medicines and combat the challenge of antibiotic resistance, and (iii) strengthen the supply security of medicines and measures to reduce the negative environmental consequences of medicines.
The Danish Government's final position on the Reform is pending an assessment and estimate of the economical consequences of the Reform. In the meantime, the Danish Government will continue to be in close dialogue with key Danish stakeholders within the pharmaceutical sector to obtain input for its further assessment and determination of its position.
Status of the Reform
The European Commission's adopted proposal has been submitted to the European Parliament and the Council for discussion. It is currently not possible to predict the timing for adoption of the proposal; however, considering the Reform's extensive nature and the European Parliament elections in June 2024, a swift legislative process is not expected.
The European Parliament's Committee on the Environment, Public Health and Food Safety has released draft reports as subsequently amended on 21 November 2023, on the proposed Regulation and proposed Directive. The reports include, inter alia, proposals for amendments to the draft Regulation and Draft directive, respectively, and are currently awaiting committee decision.
Access the draft report on the Regulation with Tiemo Wölken as rapporteur here and the draft report on the Directive with Pernille Weiss as rapporteur here.
The status on the development of the Reform can be followed on this link.
There is consensus that a reform of the EU's pharmaceutical legislation is due; however, the Reform's proclaimed - and recognisably difficult - aim of striking the right balance between incentivising innovation and increasing access and affordability of medicines has not been received as accomplished. While some stakeholders in the industry welcome the proposed Reform, others have raised serious concerns of its negative implications for innovation and the competitiveness of the EU's pharmaceutical industry.
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