HERA must address outstanding weaknesses in EU pharma framework to be successful

Medicines For Europe strongly supports the EU’s drive to learn from COVID-19 and to improve its crisis preparedness and response. The proposal to establish a European Health Emergency Preparedness and Response Authority (HERA) is an important contribution to that policy and we support its creation and will contribute to its work for the security of all Europeans.  

 Having been at the front lines of the COVID-19 pandemic, supplying critical medicines in a crisis, we acknowledge the efforts of the European Commission and the need for more efficient policies to manage future crises.  

 HERA will need to be an efficient agency with strong links to healthcare industries, including Medicines for Europe.  

 

A successful HERA must:  

  • Ensure coordination between manufacturing associations & EU authorities via the joint industrial cooperation forum  
  • Make sure EU regulations are adjusted to prioritise supply of essential medicines  
  • Eliminate the proposal for redundant manufacturing capacity  
  • It is not possible to predict which medicines will be needed in a future crisis and maintaining redundant manufacturing capacity is neither feasible nor a good use of taxpayer money. Instead, pharmaceutical policy should encourage the sustainability of manufacturing investment in a wide range of medicine production types as outlined in the Structured Dialogue. 
  • In a crisis, regulatory flexibility and competition law adaptations are more successful tools to enable manufacturers to respond to surges in demand for medicines.   
  • Include provisions for efficient strategic reserves of medicines that factor in waste and costly destruction that should be avoided. Reserve policies must be coherent and avoid distorting supplies of medicines to certain (smaller) EU countries.  
  • Overcome the significant regulatory differences applied by Member States to most emergency (nationally licenced) medicines which limits the possibility to allocate stock efficiently in a crisis.  
  • Digitalise the sector and its regulatory systems. This includes putting order on to existing digital health initiatives.   

Dysfunctional joint procurement policy must change 

The European Commission must correct the joint procurement system before using it for HERA. Most importantly:  

  • Joint procurement should not create distortions into the internal market. 
  • Provide accurate demand estimates with clear volume commitments in joint tenders. 
  • Should operate only under an exclusivity principle where participating countries commit to source their supplies from the winners of the joint procurement procedure.   
  • Be able to efficiently and swiftly contract awarded suppliers and provide clear timelines and specifications for delivery of purchased goods. 
  • Be more transparent with the possibility for industry to comment on tender criteria and the obligation for the Commission to clarify that criteria publicly and to reply to individual queries from companies in a timely manner.  

 

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.   

EU must take the lead to ensure security of supply for medicines

Legislative reforms aligned with current off-patent market conditions are the precondition for a coherent policy to improve the secure supply of essential medicines. The EU structured dialogue on medicines manufacturing is a critical first step to align stakeholders on workable reforms.

As the biggest supplier of prescription medicines, our industry is committed to improving security of supply in Europe.

for security of supply, legislative reform should cover:

  1. Up-to-date European regulation based on interconnected digital tools to improve the predictability of supply and demand on the EU market.
  2. Alignment of Member States on security of supply based on EU solidarity – notably on what are critical products, to reward companies for investments in supply chain resilience, notably by introducing smart multi criteria tenders, and to prevent distortive national stockpiling requirements.
  3. Restore European leadership in manufacturing by adapting state aid rules to enable the generic medicines and API industry to participate in national Recovery and Resilience plans for green and digital technology investments.

Speaking at the EU Structured Dialogue, Medicines for Europe President, Christoph Stoller (TEVA) outlined ““Pharmaceutical and industrial policy, must be an enabler for robust supply chains and support our industry efforts to mitigate and address the root causes of supply chain vulnerabilities, while ultimately supporting more investments in European manufacturing. The urgency is to agree and implement smart regulatory and economic policies!  In the off patent sector, the race to the lowest price has reached its limit. And rather than punishing companies via penalties or by implementing distortive national requirements such as stockpiling, we should think win win”.

Medicines for Europe Vice President Rebecca Guntern (Sandoz) said: “We need to jointly design a coherent policy to ensure security of supply for essential medicines, which is better aligned with the prevailing market conditions for off-patent medicines. Medicine manufacturing costs cannot be compressed indefinitely. We need policies that enable a meaningful digital framework, promote flexible regulatory systems and phase out unhelpful and short-sighted cost-containment measures”.

 

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.

Open borders that prioritise essential goods key to medicines supply in Europe

EU Industrial strategy should be key to improving medicines supply chains

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

“Off patent medicines essential for a fairer, healthier, and sustainable Europe” says President Christoph Stoller

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

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.

European patients need improved access to biosimilar medicines

Fifteen years after the first global approval, biosimilar medicines systemically increase access to medicines for patients who need them, while contributing to the sustainability of our healthcare systems.

We are at a unique moment for pharmaceutical policy, given the ongoing pressure from COVID-19 and the upcoming opportunities to build healthcare efficiency presented by the European Commission Pharmaceutical Strategy.

Biosimilar medicines have always been a strong asset to offer equitable access to treatment for chronic disease patients including those with cancer. Smart policies that expand biosimilar medicines use have led to efficient outcomes for patients, healthcare professionals and healthcare systems. To deliver their full potential, biosimilar medicines need:

  • The right market conditions and incentives
  • A fit-for-purpose regulatory environment, tailored to their specificities
  • To be part of standard patient care.

Isabell Remus, Chair of the Biosimilar Medicines sector group, commented COVID-19 will have a lasting impact on national health systems in Europe and their recovery will be absolutely crucial for all patients. For 15 years, biosimilar medicines provide an effective solution to balance patient access and healthcare sustainability. There are many more opportunities ahead for biosimilar medicines. Their smart use must be facilitated in practice but also in policies, like recognised in the EU Pharmaceutical Strategy and the EU Beating Cancer Plan.

 Note

These issues will be discussed in greater detail with experts from the healthcare community during the 2021 Virtual Summit on Biosimilar medicines. A series of live webinars can be attended free of charge, upon registration here.  As part of the summit, the online web platform can be accessed here, with key stakeholder interviews and background documents.

The Biosimilar Medicines Group

The Biosimilar Medicines Group is a sector group of Medicines for Europe representing the leading companies developing, manufacturing and/or marketing biosimilar medicines across Europe. With more than 10 years of positive patient treatment experience and 20 products successfully launched, biosimilar medicines provide today a huge opportunity to deliver significantly improved access to modern therapies for millions of European patients in both chronic and acute care. Our members bring competition to the biological medicines market, thereby increasing access to highly innovative treatments to patients, in Europe and around the world, and supporting the sustainability of the European healthcare systems.

New report assesses progress on biosimilar medicine policies across Europe

Biosimilar medicines are increasingly relevant to public health as emphasised by the new Pharmaceutical Strategy for Europe. The latest Biosimilar Market Review provides a comprehensive overview of policies in 26 European countries focusing on availability, pricing systemsretail markets, hospital tendering, reimbursement systems,  healthcare practitioner-related policies, information and education. 

Since the first approval of biosimilar medicine in 2006, we have accumulated over 2 billion patient treatment days in Europe alone, transforming treatment by enabling smart reinvestment of healthcare resources in better access to biological treatments while contributing to the sustainability of European healthcare budgets. 

While there are still gaps in access across Europe, biosimilar medicine competition has massively increased the number of patients that can be treated. A recent IQVIA report on The Impact of Biosimilar Competition in Europehighlighted the critical role that biosimilar medicines will play in the future as many more biological medicines are set to lose market (IP) exclusivity. This should compel the EU and member states to implement efficientgoal-oriented biosimilar medicine policies to improve patient access and healthcare sustainability. This should be based on highly successful benefit-sharing models that have proven the ability to stimulate competition and uptake.  

Commenting on the launch of the Biosimilar Market Review Kelly Burke, chair of the biosimilar market access committee of Medicines for Europe said: The Biosimilar Market Review is an important resource for stakeholders and policy-makers interested in improving access to biological therapies. While progress has been made, it is clear much more can be done to leverage benefit-sharing for better access for patients and for more sustainable healthcare. 

The 2020 Biosimilar market review can be accessed here.     

EU industrial policy can dramatically improve medicines manufacturing resilience and security of supply

New report reveals need for pricing and reimbursement and procurement reforms to ensure patient access and healthcare sustainability

Smart policies will encourage more critical medicines manufacturing in Europe