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Reports of supply shortages of breast cancer medicine (Tamoxifen) in Germany raise legitimate concerns for patients and highlight the difficulties faced by off-patent medicines manufacturers operating in markets driven by cost-containment policies. For the generics industry, the priority is to avoid bottlenecks in supply as far as possible and make sure patients can continue to access the medicines they need. We must then urgently address the universally strict cost-containment measures, which force generic medicines prices into a dangerous downwards spiral, often below the cost of goods, which are currently rising driven by steep levels of inflation.

When cases of limited supply of essential, off-patent medicines occur, the root of the issue can usually be identified by asking three key questions:

1. How many companies produce and supply this medicine? Where there are few suppliers on the market, if one has an issue, the others may struggle to cover the supply gap, especially where the production is complex.
2. How has the pricing policy shaped the market? When health systems focus on pricing only in policies, many other important factors, like supply security, are ignored.  In Germany, prices have been capped and off-patent medicines further tendered, which increases the risk of shortages. A box of 100 Tamoxifen costs 8.80eur in Germany. This price barely covers production costs and disincentivises investments in a resilient supply chain.
3. Does the EU regulatory system allow companies to find quick solutions? We support a stringently regulated EU market for medicines safety, quality, and efficacy. However, regulatory processes and procedures must be sufficiently streamlined and flexible to facilitate patient access to medicines. In shortage situations, there should be accelerated procedures to introduce necessary changes.

This is indicative of a growing trend, also highlighted by the Technopolis Study on Medicine Shortages, of generic market policy failures caused by disproportionate and short-sighted cost-containment measures combined with rapid increases in inflation.

We call on the EU and national authorities to put patients first and to start correcting the functioning of unsustainable procurement and tendering policies in the EU. This means to:

1. Ensure market predictability where tenders are only used when needed, planned, clear, transparent, and reward secure, multi-source supplies of essential medicines.
2. Avoid short-term cost containment measures like mandated price reductions, internal and external reference pricing, tendering and payback mechanisms to already low-priced generic medicines.
3. Prevent disproportionate sanctions that can increase the risk of medicine shortages.
4. Improve regulatory efficiency to reduce the administrative and cost burden of keeping medicines in the market and to enable rapid changes to supply chains and cross-country product allocation.
5. Engage with medicines manufacturers to address the root causes of medicines shortages and find concrete solutions.

The priority of Medicines for Europe members is to stabilise patient access to essential medicines. We must be met with realistic proposals and policies from our partners to address this continued situation and find real solutions for essential medicines and the patients who rely on them.

Resource hub

For more information on the situation in Germany, see https://www.progenerika.de/presse/tamoxifen/ and Q&A on https://www.progenerika.de/updates/lieferengpaesse-beim-brustkrebs-wirkstoff-tamoxifen/

Medicines for Europe position on medicines shortages https://www.medicinesforeurope.com/docs/20170927_Positionpaper_medicines%20shortages.pdf

Over 15 years ago, the world’s first biosimilar was launched. This was very much a European success story, with the European Medicines Agency leading the way to bringing more affordable biologics to patients. Biosimilars have had a tremendous impact on:  

• Patient access: Biosimilars paved the way for millions of patients to access life changing therapies, providing earlier and broader access across oncology, immunology and endocrinology. 
• Healthcare system sustainability: Through savings, healthcare systems can focus resources on innovative products to improve the lives of even more people. To date, biosimilar medicines have saved 18 billion Euro in Europe1.   

• Innovation: Biosimilars bring competition to the market, one of the most powerful triggers for further investment in research and innovation. 

However, more needs to be done to achieve equitable access to biologics in Europe.   

As stressed in the IQVIA 2021 Impact of Biosimilar Competition report: “Not all European countries have been either willing or able to increase access to biological medicines in the available therapy classes2”. There remains a lot that countries across Europe can do to increase the use of biosimilars and close access gaps, for the full benefits of patients. The Pharmaceutical Strategy for Europe must help unlock the full potential of biosimilar medicines. These calls have been echoed by the European Parliament in the report on the EU pharmaceutical strategy3 and EU beating cancer plan4.  

Isabell Remus, Chair of the Biosimilar Medicines Sector group of Medicines for Europe, said: “The access gaps will not close by themselves, this requires conscious policy-making that puts biosimilar medicines – and patients — at the centre. This can only happen with strong political leadership to drive the right mix of policies. The European Commission has been a strong ally in the past 15 years and we very much count on its leadership to keep shaping the right environment for biosimilars over the next 15 years.” 

Note  

The policy framework for biosimilar medicines will be discussed at a stakeholder focused webinar, entitled “15 Years of Biosimilars: Improving Equitable Access to Essential and Affordable Biological Medicines in Europe”. The webinar will take place at 11.30-13.00 CET on Tuesday 25th January. For more, see here.  

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 15 years of positive patient treatment experience, 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. 

The ongoing review of the EU pharmaceutical legislation framework is a major opportunity to update the EU regulatory system. Future reforms should focus on a system that delivers meaningful benefits to patients, particularly timely access to medicines supported by efficient regulatory processes, readily accessible information on medicines and better systems to manage medicines shortages.

The off-patent medicines sector accounts for almost 70% of medicines dispensed in Europe, helping to manage the most prevalent chronic diseases including cancer, auto-immune conditions, cardiac disease and diabetes. The regulatory framework must be tailored so that these medicines can readily get to the patients and healthcare professionals who need them.

The upcoming review of the EU pharma legislation should prioritise the following regulatory initiatives:

• A strong push for European-wide digitalisation, including the creation of an interoperable digital network of medicine agencies. This is essential to enable the quick exchange of regulatory data between medicines agencies and, where relevant, with industry.
• Simplify and streamline procedures, reducing regulatory burden and costs
• Prevent the unnecessary and unethical repetition of clinical studies for off-patent medicines by integrating scientific progress, supporting single development, and leveraging international regulatory convergence and cooperation.

Speaking at the Medicines for Europe regulatory affairs conference, ad interim President Rebecca Guntern said: “It’s almost impossible to exaggerate the extent to which access to affordable off-patent medicines depends on a fit-for-purpose and fully-digitalised regulatory framework. The proper functioning of this system is absolutely critical, both to get the right medicine to the right patient at the right time today and to ensure the sustainable development of the industry to meet the patient needs of tomorrow.”

The series of regulatory affairs webinars will take place between January 24th and 09th February. For more details, and to register, please visit https://www.medicinesforeurope.com/events/racphv2022/

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.

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