Medicines for Europe president Marc-Alexander Mahl outlines the challenges facing the generic, biosimilar and value-added medicines industry and its role in achieving sustainable healthcare.
Medicines for Europe represents the generic, biosimilar and value-added medicines industry; our member companies provide the majority of medicines to patients across Europe. In fact, 62% of prescription medicines dispensed to patients are generic medicines.
These medicines play a key role in the management of chronic diseases. Our medicines contribute to accessible, cost-effective and safe care for patients who can better manage their disease and lead an improved quality of life as a result.
Medicines for Europe expects that in the future, we will provide an even larger share of medicines to patients in Europe, with our forecast being in the range of 70-80% of medicines dispensed to patients being generic or biosimilar medicines by the year 2020. This enables better access to healthcare for patients in Europe.
The role of the pharmaceutical industry in sustainable healthcare
The current economic context in many countries in Europe and beyond makes durability, value for money and efficiency in healthcare systems all the more important, to ensure that patients get timely access to the medicines they need.
To continue contributing to the sustainability of healthcare systems and patient access to quality treatments, our industry needs an emphasis on sustainability and predictability.
One obvious solution which can contribute to sustaining European healthcare systems is to boost the use of generic, biosimilar and value-added medicines. These medicines make positive contributions to the management of conditions including HIV, cancer, respiratory, autoimmune and neurological diseases – to name just a few. Their positive impact has already been proven: thanks to generic and biosimilar medicines, patient access has doubled across Europe over the last ten years, meaning twice the number of patients have been treated with the medicines they need to cure or manage their disease and live better lives. Better access to medicines is a major challenge as we can see that expensive medicines are often restricted through Health Technology Assessment (HTA) or other economic rules that limit the possibility for physicians to prescribe or for patients to obtain reimbursement of many important medicines.
Yet the industry is not without its challenges. External factors play a role in threatening our sustainability, including:
- Competitiveness in the EU;
- Medicines shortages; and
- Antimicrobial resistance (AMR).
The competitiveness challenge
Competitiveness in the pharmaceutical sector is crucial to ensure supply and access to medicines for patients. The European Commission has, in May this year, launched a legislative proposal for a supplementary protection certificate (SPC) manufacturing waiver, with the intention to level the playing field in the pharmaceutical sector and encourage timely generic and biosimilar medicines competition.
Manufacturers based in non-EU countries where SPC protection does not exist (e.g. in Canada, Brazil, Russia, India and China), or where protection is shorter in duration, can enter unprotected markets up to five years earlier than is possible for EU-based manufacturers. The unintended consequence of the EU SPC Regulation is that it prevents EU-based generic manufacturers from producing during the period of SPC protection of the reference medicine for export to unprotected markets. In particular, this situation prejudices competitiveness of EU companies in the US market, where patents and patent extensions will, in most cases, expire earlier than in the EU due to the more rapid introduction of new medicines.
In addition, this situation gives an unintended lead time advantage to non-EU based operators as regards entering the EU member states’ generic medicines market immediately upon the SPC protection expiry. This forces European manufacturers of generic and biosimilar medicines to move their production outside the EU – either via delocalisation or long-term outsourcing contracts (often the only option for SMEs) – to overcome these legal hurdles and to stay globally competitive. EU reliance on foreign-manufactured medicines might be increasing, with the loss of high-value jobs in the EU.
By introducing a comprehensive SPC manufacturing waiver, cost-effective generic and biosimilar medicines could be produced and ready to enter the supply chain after originator Intellectual Property (IP) rights expire. This can bring timely access to medicines for patients while respecting IP rights, thus causing zero disincentives for innovation in the EU. An SPC manufacturing waiver would boost competitiveness in Europe, create jobs, and in the end, ensure more patients get the medicines they need in a timely manner.
In multiple reports and resolutions, the European Parliament has called on the European Commission to introduce a comprehensive SPC manufacturing waiver, covering both export and ‘day 1 launch’ in Europe, to level the playing field between European and non-EU manufacturers.
European legislators (parliament and council) now have the possibility of improving the commission proposal by including manufacturing for ‘day 1 launch’ and eliminating any anti-competitive notification procedures.
Only a comprehensive and usable SPC manufacturing waiver would address the unintended effect of the SPC regulation that has forced European generic and biosimilar manufacturers to delocalise manufacturing outside the EU.
The medicines shortages dilemma
To fully realise the potential of generic, biosimilar and value-added medicines, European governments should encourage a competitive off-patent pharmaceutical market by ensuring predictable market environments, where governments co-operate with industry to create a trustworthy and stable environment. This is key in preventing medicines shortages.
A healthy pharmaceutical market requires competition based on a healthy supply of medicines. A predictable and sustainable pricing policy and reimbursement environment will increase the number of manufacturers in the market, guaranteeing that in case one of the manufacturers cannot supply, other manufacturers in the market are able to do so. To reach that goal, we would need to revise and prevent the application of short-term cost containment measures imposed by governments on generic medicines. These government measures distort market competition and are undermining the long-term sustainability of manufacturers while increasing the risk of medicines shortages.
With the incidence of medicines shortages increasing across Europe, these issues should be dealt with in a timely way so as to ensure healthcare professionals have access to the medicines they need to treat their patients. This ultimately leads to better patient health.
The threat of antimicrobial resistance
AMR is a growing threat to global public health and development, with the potential to undermine the effective treatment of a wide range of infections and to jeopardise public health gains that come from effectively treating infections. Yet antibiotic medicines are crucial in controlling bacterial infections and, when used appropriately, are a vital pillar in the maintenance of public health.
Finding the balance between facilitating patient access to antibiotics while ensuring appropriate use requires collaboration across governments, the global life sciences industry, healthcare providers, civil society and patients to ensure effective and rapid action to combat AMR.
We also need targeted solutions for existing antibiotics which are required to maintain public health by controlling infections today. Every effort should be made to ensure these medicines continue to be available and used appropriately to ensure patients can still rely on existing, effective antibiotics. Independent reports such as those by the Access to Medicines Foundation1 are showing that the antibiotic supply chain is too stretched in Europe to ensure adequate supplies and that this is in fact undermining strategies to combat AMR.2 We need a dialogue between regulators, payers and manufacturers to address this urgently.
Medicines for Europe is committed to continuing to be a part of the solution to this global epidemic, whilst also ensuring that patients get access to the antibiotics when they are needed.
The future of pharmaceuticals in Europe
Ultimately, we remain optimistic for the future of pharmaceuticals in Europe. Medicines for Europe’s membership has made great strides in delivering effective, safe and quality medicines to patients across Europe and beyond. We remain willing and committed to working with all stakeholders to ensure that the EU market boosts its competitiveness with a comprehensive SPC manufacturing waiver, that national systems prepare to mitigate medicines shortages and ensure a healthy supply of medicines to patients, and that all parties collaborate on tackling AMR without compromising on public health.
Primarily, Medicines for Europe is committed to providing better access and better health for all patients.
References
1 https://accesstomedicinefoundation.org/publications/shortages-stockouts-scarcity/
2 https://www.pharmaceutical-journal.com/news-and-analysis/features/how-precarious-antibiotic-supplies-are-putting-patients-at-risk/20205003.article?firstPass=false
About 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 five important pillars:
1) Patients;
2) Quality;
3) Value;
4) Sustainability; and
5) Partnership.
Its members employ 160,000 people at over 350 manufacturing and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation.
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.
Marc-Alexander Mahl
President
Medicines for Europe
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www.medicinesforeurope.com
www.accesstomedicines.eu
www.spcwaiver.com
This article will appear in issue 6 of Health Europa Quarterly, which will be published in August.
