The European Semester Country Specific Recommendations show that healthcare systems need to improve their efficiency. Access to healthcare is challenged by growing demand for service and the limited financial capacity of governments to cover that demand. Generic and biosimilar medicines provide the greatest opportunity to improve access to safe and effective medicines but require efficient medicines policies to fully realise this potential. The EU Semester report indicates that healthcare reform is very challenging for many governments. However, more efficient generic and biosimilar medicines uptake policies are the low hanging fruit of healthcare reform that can be harvested quickly in all EU member states with an immediate improvement for patient access and for budget sustainability.
To fully realise the potential of generic and biosimilar medicines, European governments should encourage competition from generic and biosimilar medicines based on three overarching recommendations as well as specific measures for each country:
More details on the Medicines for Europe recommendations can be found here.
Adrian van den Hoven, Director General at Medicines for Europe commented that “The publication of the European Commission Country Specific Recommendations is an eye-opener as to the challenges many countries face in ensuring their health systems are robust and sustainable. EU institutions have repeatedly highlighted the importance of timely availability of generic and biosimilar medicines to facilitate patient access to the therapies they need to manage their condition and to improve the sustainability of national health systems’[i],[ii],[iii],[iv]. It is the duty of stakeholders including payers, regulators and the companies who supply medicines to jointly look for effective policies that promoting patient access, sustainable uptake and use of generic and biosimilar medicines. To show our commitment to this endeavour, Medicines for Europe has developed a set of Country Recommendations for seven countries to help the EU and member states develop effective policies that support access to medicines for patients”.
[i] OECD, Fiscal Sustainability of Health Systems: Bridging Health and Finance Perspectives, 2015 – https://www.oecd.org/gov/budgeting/Fiscal-Sustainability-of-Health-Systems-Policy-Brief-ENG.pdf
[ii] Investing in Health, 2013, DG SANCO, European Commission, http://ec.europa.eu/health/strategy/docs/swd_investing_in_health.pdf
[iii] DG ECFIN and Economic Policy Committee (Ageing Working Group), Joint Report on Health Care and Long-Term Care Systems & Fiscal Sustainability, 2016, http://ec.europa.eu/economy_finance/publications/eeip/ip037_en.htm
[iv] Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States – http://www.consilium.europa.eu/en/press/press-releases/2016/06/17-epsco-conclusions-balance-pharmaceutical-system/
Opening the 16th Biosimilar Medicines Conference, Keith Ridge, Chief Pharmaceutical Officer of NHS England illustrated how 3 biosimilar medicines (Infliximab, Etanercept and Rituximab) have increased access to treatment for patients while lowering overall cost of treatment in important therapy areas.
Carol Lynch, President Sandoz US, Head of North America and Chair of the Biosimilar Medicines Group at Medicines for Europe, commented: “With 12 years of positive experience and a wealth of confirmatory data on biosimilar use, we are now focused on sharing best practice to increase access to biosimilar medicines. Germany and the UK have been pioneers in launching biosimilar medicines projects and their healthcare systems and their patient community have seen the benefits of increased access and sustainability. We need to build on this to expand the biosimilar opportunity globally.”
Biosimilar medicines are an essential part of healthcare provision in Europe today. Europe will continue to play a leading role in shaping a sustainable regulatory framework regionally and globally to promote greater access to essential therapies for auto-immune diseases and cancer. The Biosimilar Medicines Group has pioneered this development and supports greater global cooperation for future development.
Key authorities, lawyers and industry leaders discussed today in London the key issues in the spotlight for the pharmaceutical industry legal framework: Brexit, the SPC regulation and changes in the EPO. The high level event assessed how various aspects of law affect access to generic, biosimilar and value added medicines in Europe.
The fast changing legal environment was assessed in areas such as the impact of Brexit on the industry, competition in pharmaceuticals including the European incentives review and biosimilar medicines litigation. Interactive expert roundtables covered highly technical topics including second medical use patents, paediatric extensions, statute of limitations in nullity actions, the falsified medicines directive, the role of competition policy to ensure free markets, the concept of plausibility, the practice of search and seizure, and disclosure and data protection and industry codes of conduct.
The anticipated Commission proposal for an SPC manufacturing waiver for pharmaceutical production and R&D in Europe and to foster high-skill job creation and economic growth was discussed in depth. According to a report published by the European Commission, the SPC manufacturing waiver would:
“Today’s conference reviewed pathways to encourage competition as well as innovation and growth in the pharmaceutical sector. Patients, governments and healthcare systems rely on a strong generic, biosimilar and value added medicines industry to increase access to medicines and to create jobs for Europe”, said Sergio Napolitano, Legal and External Affairs Director at Medicines for Europe, speaking ahead of the 14th Legal Affairs Conference, “an efficient, pro-competitive legal environment that includes the SPC manufacturing waiver will boost investments in our sector, facilitate faster access to medicines for patients, contribute to the sustainability of healthcare systems across Europe and we stand ready to support these positive measures”.
We, the signatories of this declaration, recognise and understand the concerns regarding the presence of pharmaceuticals in the environment.
We believe that these concerns can only be addressed through a dialogue with policy-makers, taking into account public health and environmental aspects, as well as their policy ramifications, and we pledge our commitment to remain open and constructive partners in this debate.
We look forward to the European Commission EU-wide strategy on pharmaceuticals in the environment. We call for a balanced approach that is mindful of the underlying essential role of medicines. We recognise that environmental protection contributes to safeguarding the health and safety of future generations; however, medicines also play a critical role in ensuring a high level of public health. As a matter of policy, we believe that any environmental-based measures should be clearly justified and guarantee patient access as well as access to the demonstrated benefits that medicines bring to public health.
We confirm our commitment to take actions in the areas where we can make a difference in order to reduce the presence of pharmaceuticals in the environment.
One such example of our commitment is the #medsdisposal campaign, a collaborative multi-stakeholder initiative aiming to raise public awareness about the correct disposal of unused and expired medicines. Around 8-10% of pharmaceutical substances in the environment originate from improperly disposed medicines – flushed down the toilet, poured into drains, or otherwise disposed inappropriately in household waste by patients or even by medical institutions [1],[2]. Educating citizens across the EU can therefore lead to a change in behaviour that can make a substantial difference.
While there is no evidence of harmful concentrations of active pharmaceutical ingredients in the European drinking water[3], we recognise that the possible impact of pharmaceuticals on the environment is generally unknown, and we support and encourage more research to identify and evaluate potential risks.
In addition, the representatives of the health sectors signing this declaration are taking additional actions in their own sectors to address the concerns around pharmaceuticals in the environment:
We would like to encourage more stakeholders to join and endorse the #medsdisposal campaign and pledge their commitment to address environmental concerns around pharmaceuticals. Should you be interested in doing so, do not hesitate to be in contact by email medsdisposal@gmail.com.
ABOUT US
#medsdisposal is a campaign to raise awareness on how to dispose of unused or expired medicines appropriately in Europe, bringing information on current disposal schemes in European countries to one place. It is a joint initiative between European healthcare, industry and student organisations including, among others:
AESGP
AESGP, the Association of the European Self-Medication Industry, is the representation of manufacturers of non-prescription medicines, food supplements and self-care medical devices in Europe. It is composed of national associations and the main multinational companies manufacturing self-care products. AESGP is the voice of more than 2000 companies operating in the consumer healthcare sector in Europe, affiliated with AESGP directly or indirectly through the national associations.
www.aesgp.eu
CED
The Council of European Dentists (CED) is a European not-for-profit association, which represents over 340,000 practising dentists through 32 national dental associations and chambers from 30 European countries. Its key objectives are to promote high standards of oral healthcare and effective patient-safety centred professional practice across Europe, including through regular contacts with other European organisations and EU institutions. The CED is registered in the Transparency Register with the ID number 4885579968-84.
EFPIA
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 40 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world.
www.efpia.eu
EPSA
The European Pharmaceutical Students’ Association (EPSA) represents more than 160,000 students and recent graduates from 37 European countries. The Association has a permanent office in Brussels and conducts its activities through regular congresses, advocacy activities, training events, publications, exchange programmes and virtual presence. The mission of the Association is to actively engage at student and professional level, bringing pharmacy, knowledge and students together while promoting personal development.
www.epsa-online.org
GIRP
GIRP is the umbrella organization of pharmaceutical full-line wholesalers in Europe. It represents the national associations of over 750 pharmaceutical full-line wholesalers serving 34 European countries, including major pan-European pharmaceutical full-line wholesaling companies
www.girp.eu
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 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. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.
PGEU
The Pharmaceutical Group of the European Union (PGEU) is the association representing the 400.000 community pharmacists from 32 countries across Europe.
www.pgeu.eu
[1] Kümmerer, 2009: The presence of pharmaceuticals in the environment due to human use: present knowledge and
future challenges. J. Environ. Manage. , 8:2354–2358.
[2] European Environmental Agency, Pharmaceuticals in the environment, 2010:
http://www.eea.europa.eu/publications/pharmaceuticals-in-the-environment-result-of-an-eea-workshop/at_download/file
[3] WHO, Pharmaceuticals in Drinking-water, 2011:
http://www.who.int/water_sanitation_health/publications/2011/pharmaceuticals_20110601.pdf
Today’s agreement on a transition period is welcome news for Europe’s Life Sciences industry. While expecting a deal on the withdrawal agreement as soon as possible, this gives companies more certainty about the time they will have to prepare for the UK’s departure from the EU.
At the current status of negotiations, we continue to advise our members to prepare for every scenario and ensure that they have the right plans in place so that patients across Europe and in the UK continue to access the medicines they need.
However, as Article 50 negotiations progress to the next phase, clarity over the UK and Europe’s future relationship on the regulation, trade and supply of medicines needs to be provided as soon as possible. Alongside Europe’s patient groups and healthcare organisations, Europe’s Life Sciences industry will continue to advocate that the best outcome for patients is an agreement for the EU and the UK to continue to cooperate on medicines.
The European Health Community has warned that time is running out to secure patients’ interests in Brexit negotiations. With Phase 2 of the negotiations looming, health groups across Europe have drawn up a list of crucial unanswered questions that must be answered by the EU and UK negotiators to ‘put patients first’ in the negotiations.
These questions were set out at a meeting of a Coalition of Brussels based health stakeholders on 21 February and have been released in advance of the European Council meeting on 22 March, where the guidelines for the negotiation of phase 2 will be agreed. These focus on how to prioritise patient safety and public health in the Article 50 negotiations on the future relationship between the UK and the EU. Each speaker posed three questions of importance which will need resolving for patients.
The Group has now published this document in light of the discussions by the EU27 on the draft guidelines for the future relationship between the UK and EU in the weeks to come. Some of the key questions the Coalition sets out are:
This follows on from the publication of a policy statement by the same group in December 2017[1]. The document outlined five priorities, which the group says will ‘determine the risk in Brexit’s impact on patients and public health across Europe’.
These priorities are:
Nicola Bedlington, General Secretary, European Patients Forum
“Brexit has great implications in various areas, public health, patient safety, access to medicine and medical devices, research and many others. This is so, not only for patients residing in the UK, but also in the rest of the EU(27). When it comes to those areas relevant to healthcare, patients’ interest should be shaping the agenda of both sides of the negotiating parties”
[1] http://www.eu-patient.eu/globalassets/library/publications/brexit–prioritising-patients—final.pdf
This week in London, Medicines for Europe gathers regulators and industry leaders to discuss future opportunities and challenges in the regulatory environment of the generic, biosimilar and value added medicines industry. Future changes in the regulatory landscape as a result of Brexit and the implementation of the Falsified Medicines Directive (FMD) will be discussed over the course of a two day conference in London. The opportunities for regulatory optimisation and international convergence will also be advanced as positive trends for the future.
The optimisation of regulatory operations, reflected in the HMA/EMA and CMDh 2020 workplans, are an important milestone for regulators and industry. In particular the ‘Regulatory Optimisation Group’ (ROG) offers a promising platform to find practical solutions for regulatory efficiency and operational excellence. Medicines for Europe will support this optimisation process for the benefit of patients and partners involved in or impacted by regulatory activities.
Marc-Alexander Mahl, Medicines for Europe President commented: “This conference provides an invaluable platform for stakeholders to adapt to the challenges posed by Brexit and FMD implementation while seizing opportunities to progress on regulatory optimisation and convergence for a more efficient system. Efficient regulatory systems will play a key role for patient access to medicines across Europe.”
Photos:
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