The newly launched update of the industrial strategy aims to support Europe’s recovery and boost open strategic manufacturing in Europe. With COVID-19 still a threat, Europe’s economic health and global interdependence requires attention. Few sectors could be considered more strategic than healthcare.

Medicines for Europe members supply and manufacture the majority of emergency medicines (70-90% of ICU medicines), anti-infective medicines and chronic care medicines, widely used to treat cancer, cardiac conditions, infectious and respiratory diseases including COVID-19. Essential medicines are produced in over 400 manufacturing sites across Europe. Yet the sector operates under cost-containment policies by member states and has consolidated over time.

While Europe remains a major global manufacturer of active pharmaceutical ingredients (API) and on complex medicine production processes[1], the reality is that India and China are growing their production at a much faster rate. India and China are also pursuing robust industrial strategies to encourage an expansion of medicines production in their territories. The COVID-19 pandemic underlined the critical importance of robust medicines manufacturing capabilities and should encourage the EU to pursue a smart industrial strategy for pharmaceutical production including:

Coordination with relevant stakeholders: the structured dialogue on pharmaceutical manufacturing will identify the strengths and weaknesses and strengths of pharmaceutical supply chains and will propose policy reforms to incentivize investments in manufacturing and robust supply chains.
Smart market policies: The EU market for generic medicines must be reformed. Cost-containment reimbursement measures and procurement policies do not encourage investment in manufacturing and supply chain resilience. This has been recognised in the Pharmaceutical Strategy for Europe and it must be implemented with real requirements for policies that look beyond the lowest price only and encourage security criteria, such as support multiple suppliers and the green transition.
Digital transformation in the regulatory network: regulatory processes must be digitalised and medicine agencies interconnected to improve the efficiency of regulatory procedures. This has obvious benefits including more effective prevention of shortages and over-consolidation.
Targeted Funds: NextGenerationEU recovery instruments should support medicines manufacturing as a key strategic pillar for Europe to boost secure and resilient supplies. This should include clear measures to provide grants for investments in manufacturing in Europe and to review EU state aid requirements to take account of the security of supply.

Medicines for Europe President, Christoph Stoller (TEVA) said: “It is painful to see Europe gradually losing its essential pharmaceutical production. This cannot continue. The EU industrial strategy published last week is an important first step to slow this process but tailored actions for the healthcare industry are needed. The EU has set up important initiatives to move in this direction, such as the EU structured dialogue on medicines manufacturing. We need a robust manufacturing policy focusing on critical manufacturing technologies to strengthen EU resilience and deliver equitable access to medicines. but we would like to see this reflected across European Commission directorates. Medicines for Europe will engage constructively to achieve this goal together, supporting the security of supply of medicines.”

Medicines for Europe

Medicines for Europe represents the generic, biosimilar and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.

[1] European Commission staff working document, page 136

Christoph Stoller will speak at 3A CONFERENCE – Availability, Accessibility, Affordability of Medicines and Medical Devices, organised by the Portuguese Presidency of the European Union at 11.30AM CET.

When I took over the Presidency of Medicines for Europe in 2019, I made sustainable and equitable access to medicines a priority for our sector. I set out to identify key recommendations to protect access to affordable medicines, while supporting a vibrant and strategic medicines manufacturing base in Europe.

As COVID-19 changed our perspectives on EU health policy, these issues are gaining traction and are heavily featured in the in the pharmaceutical strategy.

Off-patent medicines deliver equitable access to medicines. Generic medicines have doubled access for patients with diabetes and cardiac conditions and represent 70-90% of ICU medicines. Biosimilar medicines are drastically increasing access to biological therapies for cancer and auto-immune conditions such as rheumatoid arthritis or psoriasis and value added medicines are increasing patients’ quality of life for chronic diseases and we have seen this in action, as medicine repurposing has been a cornerstone in the response to COVID-19.

COVID19 has been a wakeup call and in my view has demonstrated three key priorities which still require action:

Off-patent medicines must be clearly recognised in EU pharma strategy’s implementation: Off-patent medicines deliver equitable access to medicines. Barriers to access on day-1 of generic and biosimilar medicines competition should be removed. Generic and biosimilar medicines uptake should be promoted.
Resilient and robust supply chain should be fostered: Smart and sustainable market reforms (also via procurement reforms to introduce multi winner, multi criteria models) should be implemented. These drive value for healthcare systems and patients rather than a race to the bottom by focusing on cost only, a factor in driving manufacturing outside Europe. Regulatory optimisation is needed including embracing digital solutions and processes (such as variations, telematics and eLeaflet).
Embrace digital and at-home solutions for patients: Value added medicines have come to the fore during COVID-19. We must find a way to accelerate this and benefit from the lessons we’ve learned to date, including to reflect on the impact that COVID-19 has on non-COVID-19 patients.

– Christoph Stoller

President, Medicines for Europe (Teva)

Medicines for Europe

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In response to the European Commission Trade Communication published on 18 February 2021. During Covid-19, Medicines for Europe was strongly engaged to ensure continued access to medicines for patients while protectionism, hoarding measures and panic policies undermined these efforts. The emergency has highlighted the need for closer international health collaboration and for governments to work together with industry to balance emergency health measures with free flow of medicine supply chains. Since the pharmaceutical sector is highly regulated, stronger international regulatory cooperation, especially related to generic and biosimilar medicines which represent the overwhelming volume of medicine supplies, would reduce unnecessary duplications for industry and regulatory agencies, and improve equitable access to medicines.

The EU should focus its trade agenda on pharmaceuticals on the following measures:

Stronger cooperation on supply chain security. While emergency health measures are needed in a crisis, they can unintentionally undermine access to medicines by blocking trade in medicines or their components. In a joint effort with the WHO and the WTO (to cover health emergency and trade matters), governments should align on specific mechanisms to limit the potential disruption caused by emergency health measures to the medicines manufacturing supply chain. This could be complemented at the bilateral level by extending Good Manufacturing Practice (GMP) mutual recognition agreements with other highly regulated markets starting with the UK.
Stronger regulatory cooperation. The Commission should promote global generic and biosimilar development programmes to accelerate access to essential medicines and eliminate the unnecessary duplication of regulatory steps.
Defend open trade. The EU should vigorously support the opening of medicines procurement markets and oppose with equal vigour the reneging of existing commitments by the US in the WTO Government Procurement Agreement;

Stronger cooperation on Intellectual Property. Europe has one of the strongest IP system at global level. It is fundamental that any negotiation on IP with third countries is balanced and take into account the market, legal and regulatory environment of both regions. Therefore, in trade negotiations, the European Commission should evaluate the concrete impact of IP on generic and biosimilar medicines access for both parties. In addition, it should be assessed whether the imposition of European IP standards in third countries has a positive effect on export of European manufactured medicines.

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