The European Commission published its 'Pharmaceutical Strategy for Europe', laying out plans for the pharma industry: tackling new challenges showcased by the Covid-19 pandemic and older ones, e.g. insufficient treatments for unmet needs, growing antimicrobial resistance, accessibility and affordability of medicines.
The pharmaceutical industry provides 800,000 direct jobs in the European Union and spent over 37 billion euros on research in 2019. Start-ups, SMEs and large companies produce patented medicines or generics and biosimilars. Luc Triangle, industriAll Europe’s General Secretary: “We see an industry in constant change. Big established names change their portfolios or concentrate on a few therapeutic areas. New players enter the market. And with digital tools playing an increasing role in Research and Development, the industry attracts more and more technological companies. This poses challenges for workers in the industry which need to be thoroughly assessed and tackled.”
Innovation for unmet needs and antimicrobial resistance
One of the goals of the Pharmaceutical Strategy is to address unmet needs, most notably rare diseases. Treatments have not been developed, due to either a lack of commercial interest or scientific limitations. To change this, the Commission envisions funding, through European projects and research funds, and fostering cooperation between academia, industry and health institutions.
The other focus area is antimicrobial resistance. A growing number of illnesses cannot be combatted because the causative organisms have grown resistant to available medications. Stepped up research is one part of the answer. There is also a need to increase awareness of prudent use and possibly even for legislation to restrict and optimise the use of antimicrobial medicines. The Commission’s plans recognise this.
“IndustriAll Europe has contributed on several occasions to the content of the strategy. And we have been heard. The explicit reference to gender, age and ethnicity-sensitive clinical trials was our demand.”
The strategy recognises the need to continue creating quality employment opportunities in the EU throughout the pharmaceutical value chain. It appeals to all key players in the sector to pool their resources and invest in upskilling and reskilling. Various EU programmes aim to boost the number of STEM graduates and teachers. “We welcome the commitment of the Commission in this field, and we will play our part to make sure that any policy in this area will also benefit workers, not only companies. Quality employment, combined with more education and training, is key for the future of this sector in Europe.”
Open strategic autonomy
The COVID-19 pandemic raised public awareness about the shortages of medicines. They have been a concern in Europe for several years. Reasons for shortages can be scarce active pharmaceutical ingredients, marketing strategies, pricing and reimbursement issues.
The strategy promises to identify strategic dependencies and to propose measures to reduce them: diversifying supply chains, ensuring stockpiling, fostering production and investment in Europe. Luc Triangle: “This strategy goes further than any other communication on essential goods or value chains: It actually considers the need for more European-based production. The health of citizens cannot be at the mercy of decisions made by pharmaceutical companies based on profit arguments only.”
Legislative measures could include stronger obligations on industry to ensure the supply of medicines, earlier notification of shortages, and a stronger coordinating role for the European Medicines Agency (EMA) in monitoring and managing stocks.
Access to affordable medicines
The Commission considers targeted policies to enhance generic and biosimilar competition, the removal of barriers that delay their timely market entry and increased uptake by health systems. Public procurement procedures and cooperation are to be encouraged. Health systems and private companies can cooperate by using the ‘innovation partnership’ tender procedure that allows public buyers to establish a partnership for the development, manufacture and subsequent purchase of medicines with limited demand.
Luc Triangle: “We already see mixed responses from industry. Big companies with strong research interests are concerned about the Commission’s ambition to enhance transparency with respect to R&D costs - and to influence pricing through a debate about fair return on research investments. Producers of generics are optimistic about plans to facilitate market entry. It is important to strike the right balance. Certainly, as soon as there is public funding involved, but not only then, the authorities must have a say in pricing and marketing.”
IndustriAll Europe, together with its affiliates at national level, will closely follow the concrete actions that will follow this Pharmaceutical Strategy for Europe. We will also examine what it may mean for EU neighbouring countries, including EU Candidate Countries. It is crucial that trade unions and workers will be strongly involved in the implementation of this Strategy.