EU Pharma Strategy: VNO‑NCW and MKB‑Nederland response

The Confederation of Netherlands Industry and Employers (VNO-NCW) and The Royal Association MKB-Nederland are the largest Dutch industry and employers' organisations, representing around 90 percent of private business. VNO-NCW and MKB-Nederland welcome the opportunity to provide feedback on roadmap on the future of the pharmaceutical industry in the European Union.

The current COVID-19 pandemic is in many ways a symbolic microcosm of the ongoing debates about the pharmaceutical sector. On the one hand the enormity of the impact of the pandemic makes evident the necessity of an up-to-date legal framework that can speedily adapt to novel processes, an expedient system of licensing procedures, and a political and fiscal climate that is conducive to innovation/R&D of new treatments. On the other hand, the widespread nature of the health crisis also puts an emphasis on the affordability of, hopefully rapid, vaccines and cures. COVID-19 is merely a harbinger of potential threats to the health of Europe's citizens and underlines the need for a strong EU medical eco-system.

For these reasons we wholeheartedly welcome and subscribe to the roadmap on the future of the pharmaceutical industry in the European Union presented by the European Commission. We view the EU Pharmaceutical Strategy as having the potential to support Europe's medical research eco-system, enhance the region's resilience to global health threats, address our on-going (and future) health challenges as well as be a key driver for the EU's economic recovery. We derive the following focus areas from the roadmap:

• Reducing production and supply chain dependency on third countries by stimulating the EU's own pharmaceutical sector
   
• Guarantee accessibility of pharmaceuticals by promoting market access, production and innovation
   
• sure affordability of pharmaceuticals and the fiscal durability of our healthcare system
   
• Encourage innovation, including digital solutions to increase the quality of healthcare

In our view, the major added value of a EU pharma strategy should be to explore and create win-win-situations for all stakeholders involved (patients, taxpayers/employers and industry), especially by examining the market structure at a EU level (see our point 8-11 below).

Strategic autonomy and COVID-19

1. The EU has been looking more strongly at increasing its economic resilience and strategic autonomy. The industrial strategy, presented in March, will play a fundamental role in achieving the evident need for the EU becoming less dependent on third countries for strategic value chains. Primary examples include EU supply chain resilience on key medical devices and (certain) medicines. Another priority is an EU (critical) raw material strategy that ensures access to raw materials used in the production of pharmaceuticals, as these are currently dominated by India and China.
    
2. The COVID-19-crisis gives an immediate and severe impetus to this ambition. Also, with vaccines, we see the United States claiming the entire early supply at the expense of individual EU-member-states' efforts to secure access to them.
    
3. To ensure the EU's ability to pursue such medicines vital for beating this pandemic and mitigating its severe economic fallout, stimulating a strong European pharmaceutical sector is crucial. This includes a research and manufacturing infrastructure that delivers the next generation of vaccines and treatments, developing clinical trial networks, biobanks and data banks, building a European health data space, delivering public-private collaboration mechanisms to accelerate bringing health solutions to patients and encouraging innovative manufacturing.
    
4. As a sector with a unique role for its benefits to our citizens' health, high economic value added and high-quality jobs, the EU's pharmaceutical sector is also a strategic area for a more R&D-focused, mission-driven EU innovation policy. Horizon Europe and national R&D&I budgets should contribute to this.
    

Distinction between innovative and generic medicines

5. In the pharma strategy a clear distinction should be made between generic medicine and innovative medicine, protected by intellectual property law (IP). The first group creates important low-skilled employment and ensures the EU's domestic production and supply of important everyday medicines. The second group substantially adds economic value and provides high-skilled employment and major R&D-investments. Innovative medicine does require a strong IP-framework to ensure investment into the development of future treatments, including for rare and paediatric treatments, remains predictable and thus attractive.
    

Health and data interlinked

6. The digital transformation of the healthcare sector creates new opportunities, within the framework of a European FAIR data economy. We would like to address the challenge of how to use health and social data more efficiently in the development of new drugs and personalized medicine. We propose building a European health data space to accelerate bringing health solutions to patients and encouraging innovative manufacturing.
    
7. For this it is crucial to create a competent legal framework and regulatory authorities that are conducive to the performance of these digital health-solutions. An example is the recent Finish Law on Secondary Use of Health and Social Data¹, which facilitates the use of data from different registers and therefore an easier and efficient use of data in R&D with the GDPR requirements. This topic is also part of our current industry dialogue with our sister organizations from other EU27 member states on the European Health Data Space (which is initiated by BDI).
    

EU: greater than the sum of its parts

8. The root causes behind inequalities between EU-member-states' healthcare systems are multi-factorial: including late start of market access assessment, duplicative evidence requirements, national pricing and reimbursement policies and companies' behaviors responding to these and other factors. They can only be addressed by stakeholders working together. This may also address the EU's stated objective of, and commitment to, ensuring accessibility and affordability of pharmaceuticals throughout the EU.
    
9. In addition to the themes mentioned above, VNO-NCW and MKB-Nederland would like to see the EU Pharmaceutical Strategy include an exploration of novel ways to create win-win situations for patients, taxpayers, employers and industry. A critical look at the EU's single market structure regarding pharmaceuticals could discover ways to increase the quality of Europe's healthcare system as well. Market size gives greater societal leverage in price discussions between governments, producers and insurers, and increase accessibility to, and reimbursement of, medicines for all citizens due to the EU's greater market power and appeal.
    
10. This critical look can extend to ways to ease the development process of treatments, in order to reduce both development time and cost, and consequently increase accessibility and affordability. For example, the pharmaceutical sector sees relatively high capital costs². The EU could find out potential bottlenecks in pharmaceutical development and take action accordingly. We see great potential added value in fiscal and financing instruments to bring down costs and risks in the EU's pharmaceutical development.
     
11. Another example is to streamline and shorten the process and time required to bring new medicines to the European market. The EU has relatively taxing processes that lengthen the development time of new treatments, with potential detrimental consequences for patients as is currently exemplified in the advantage of the US and China in COVID-19 vaccine development.
     

VNO-NCW and MKB-Nederland, together with our members from the healthcare sector (pharmaceutical industry, healthcare insurers and healthcare providers) would be happy to engage with you further on realizing these important ambitions.

¹ https://stm.fi/en/secondary-use-of-health-and-social-data
² See Gupta, 2019, The Cost of the Opportunity,