Medicines for Europe welcomes the European Parliament’s Committee on Environment, Public Health and Food Safety’s (‘ENVI’) support for an SPC manufacturing waiver.
ENVI voiced its support in its Draft Opinion on the proposal which was published by the Committee on 13 September last.
The ENVI Committee Rapporteur, MEP Tiemo Wölken (S&D, Germany), welcomed the proposal to amend Regulation (EC) No 469/2009 which provides a supplementary protection to medicinal products. Mr. Wölken acknowledged that the amendment proposal was in line with the European Parliament’s commitment to improve access to medicines for patients.
Currently, as a result of the existing SPC regulation, EU-based generic and biosimilar medicine manufactures face restrictions which limit their capacity to manufacture and export to countries outside the EU where no SPC applies. This places these companies at a competitive disadvantage to those outside of the EU.
The existing manufacturing restriction also denies European patients access to more affordable medicines from the first day on which the SPC expires, due to the long lead-in times required to produce medicines.
Mr. Wölken acknowledged the need to “restore the level playing field between EU-based generic and biosimilar manufacturers and non-EU based ones, boosting the competitiveness of EU manufacturers….as well as facilitating Day-1 entry within the Union.”
He also pointed to the need to “reduce barriers to access to medicines”, noting that “producing within the EU can lead to enhanced security and quality of supply, reduced counterfeits and uncertainty due to import reliance”.
Medicines for Europe Director General Adrian van den Hoven welcomed the draft opinion of ENVI, stating:
“ENVI’s draft opinion is a significant one. It ensures that the introduction of an SPC manufacturing waiver now moves a step closer to being realised. The extensive consideration given to this proposal by ENVI, including its Rapporteur MEP Tiemo Wölken and others such as MEP Cabezon Ruiz (S&D, Spain), must be acknowledged. ENVI’s amendments to the Commission’s original proposal, including the need for Day-1 launch and the removal of the disclosure of some commercially sensitive information enhance the proposal further. At the same time, some additional improvements to the proposal can be achieved, especially with regard to the need for applying the SPC manufacturing waiver as soon as possible in order for it to serve the purposes it is meant for, as well as making sure that the system can function, notably getting rid of the disclosure of all of the commercially sensitive and confidential information within the notification requirement.
“ENVI recognises the important, and much needed, reforms which this proposal will deliver for European patients and for the competitiveness of European pharmaceutical manufacturers. The Committee’s Draft Opinion acknowledges the SPC waiver’s key public health benefits – faster access to affordable medicines, enhanced security and quality of supply, improved competitiveness for EU-based generic and biosimilar manufacturers, whilst reinforcing the EU’s position as a hub for pharma innovation and manufacturing.
ENVI have been unequivocal in their support of this proposal in the past, and MEP Tiemo Wölken has confirmed this in its Draft Opinion. Medicines for Europe now urges the other ENVI rapporteurs and European Parliament committees, JURI and INTA, as well as the other policymakers – at national and European level – to support this line and prioritise the introduction of this proposal”, added Mr. van den Hoven.
ENDS.
Note for editors
A comprehensive and workable SPC manufacturing waiver will generate huge opportunities for Europe as highlighted in the Charles Rivers Associates study – the only independent study on this issue commissioned and published by the European Commission:
Link to ENVI draft opinion: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-%2f%2fEP%2f%2fNONSGML%2bCOMPARL%2bPE-627.040%2b01%2bDOC%2bPDF%2bV0%2f%2fEN
Definitions
Medicines for Europe is committed to bringing accessible, high quality medicines to patients across Europe. Already today our industry supplies 63% of dispensed medicines in Europe.
As part of our commitment to improve public health, Medicines for Europe and its members regularly engage and collaborate with the stakeholder community, including healthcare professionals and patient representatives. This enables us to deliver accessible healthcare solutions that work best for our stakeholders, and ultimately contribute to the sustainability of healthcare systems across Europe. Disclosure of transfers of value related to these interactions enables the industry, healthcare professionals and patient organisations to jointly promote shared values of transparency, integrity, accountability and collaboration.
All Medicines for Europe corporate members, including the corporate members of our national associations, are required to disclose according to the trade association Code of Conduct. Where national legislation or rules already require this, companies must follow the law of the specific Member State and of the Medicines for Europe code (in cases where our rules are stricter).
In accordance with the Medicines for Europe Code of Conduct, disclosure is to be made on an annual basis and each reporting period covers the previous calendar year. The first reporting period is calendar year 2017, with disclosures published by June 30, 2018. The information will be published on the website of each member and will be accessible to the public. Where disclosure is made through a national authority database, the information will be available on that authority’s website.
The Medicines for Europe Code of Conduct and information on the disclosure by our association are available on our website.
The joint 24th Medicines for Europe and 21st IGBA Annual Conference began today with key industry leaders coming together in Budapest, Hungary, to discuss the challenges and opportunities for the global generic, biosimilar and value added medicines industries.
Challenges related to industry sustainability were debated with key experts, who shared perspectives on topics such as medicines shortages, use of data, Brexit, international regulatory cooperation and the EU Falsified Medicines Directive (FMD). European industry leaders outlined the period of intense preparations to ensure compliance by the early 2019-milestones for FMD and Brexit.
The conference also underlined the exciting opportunities ahead for the industry. Having welcomed the European Commission legislative proposal for an EU SPC manufacturing waiver in May this year, Medicines for Europe is committed to supporting such industrial policy initiatives which can strengthen the European industrial base, increasing investments in R&D for biosimilar medicines, boosting EU competitiveness, and delivering faster access to medicines for patients.
Marc Alexander Mahl, President of Medicines for Europe, commented that “Medicines for Europe is committed to engaging with stakeholders and decision makers to improve patient access. In fact, to showcase our strong manufacturing footprint in Europe, Medicines for Europe has decided to launch an ‘Industry manufacturing week’, in which member companies will open production plants across Europe for stakeholders. We are leading suppliers of medicines for European patients and we want to engage with local communities to show that we are an integral part of the health ecosystem. “
David Gaugh, Chair of IGBA and Senior Vice President at the Association for Accessible Medicines, USA, commented that “the global perspective of the industry is crucial; key objectives such as international regulatory harmonisation and global collaboration to ensure the uptake of generic, biosimilar and value-added medicines can bring real benefits to patients – access and affordability are objectives we all share, right across the globe.”
Mr László György, State Secretary for Economic Strategy and Regulation, stated that “the primary goal of the newly established Ministry of Innovation and Technology is to maintain and improve decent living conditions and enhance the competitiveness of the pharmaceutical industry, which plays a decisive role in the Hungarian economy.”
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.
The International Generic and Biosimilar Medicines Association (IGBA) was founded as IGPA (International Generic Pharmaceutical Alliance) in March 1997 to strengthen cooperation between associations representing manufacturers of generic medicines from around the world. Its membership includes AAM (USA), CGPA (Canada), GBM – Southern Africa (South Africa), IPA (India), JAPM (Jordan), JGA (Japan), Medicines for Europe (Europe), and TGPA (Taiwan), while the associations from Australia (GBMA), Brazil (ProGenericos), Mexico (AMEGI), and Malaysia (MOPI) are Associate Members. The IGBA is at the forefront of preserving sustainable competition within our industry, by stimulating competitiveness and innovation in the pharmaceutical sector; thereby, ensuring millions of patients around the world have access to high quality, pro-competitive medicines. Through its constituent member associations, the IGBA maintains constant dialogue with government authorities around the world, as well as with international institutions such as WTO, WIPO and WHO. More information: www.igbamedicines.org
Nonetheless, we are concerned that the legislative proposal does not fully address the unintended effects of the SPC Regulation, specifically production for ‘day 1 launch’ in Europe after SPC expiry, as was clearly announced in the European Commission Single Market Strategy for Europe in 2015. The Commission published the Charles River Associates (CRA) study which showed the importance of allowing generic and biosimilar manufacturers to prepare for launch in Europe at SPC expiry – with thousands of manufacturing jobs and lower national government drugs bills at stake (see addendum below). This is underlined in the Explanatory Memorandum of today’s proposal which surprisingly is not included the draft legislative amendment. The draft also contains a few anomalies that undermine its stated intentions and give limited practical effect to the amendment for SMEs which hope to benefit from this opportunity.
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’, to level the playing field between European and non-EU manufacturers.
Legislators (Parliament and Council) now have the possibility of improving the Commission proposal by including manufacturing for ‘day 1 launch’ and correcting the anomalies that limit its effective use for SMEs. 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.
Marc Alexander Mahl, President of Medicines for Europe commented that “the launch of the SPC manufacturing waiver legislative proposal is a very positive step to create manufacturing jobs in Europe, and to boost competitiveness by allowing EU companies to compete on a level playing field. However, this proposal should allow companies – especially SMEs – to prepare for ‘day 1 launch’ after expiry in Europe. Without this, European patients will not get timely access to European manufactured generic and biosimilar medicines.
For products with large investments in development and manufacturing infrastructure, like biosimilar medicines, EU `day 1 launch´ capability is a key criteria for localisation in Europe. Imported biosimilar and complex medicines from non-SPC markets will be available on ‘day 1’, while EU-based manufacturers would be specifically blocked from competing in the critical phase of market formation.
Our call now is on the European Parliament and Council to rapidly adopt the proposal with the right to produce for launch in Europe, which will increase access to medicines for patients, lower drug costs for national health budgets and benefit a dynamic European industry.
We have also gathered the key documents and resources pertaining to the SPC manufacturing waiver on the newly-launched website www.spcwaiver.com. This website aims to gather concrete and legitimate information about current SPC protection and the complete SPC manufacturing waiver for medicinal products in the EU and its consequences, as well as appropriate ways to strengthen the European economy.”
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. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU. For information on the SPC manufacturing waiver, please see www.spcwaiver.com.
A comprehensive and workable SPC manufacturing waiver will generate huge opportunities for Europe as highlighted in the Charles Rivers Associates study – the only independent study on this issue commissioned and published by the European Commission:
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”.
