The European Parliament today voted overwhelmingly with 572 Members of Parliament in favour to adopt the Supplementary Protection Certificate (SPC) manufacturing waiver. The SPC manufacturing waiver is now expected to be formally adopted by the European Council in the coming weeks.
Medicines for Europe commends the EU institutions for successfully concluding this important step in the adoption of the waiver. We congratulate the European Commission for proposing the waiver and the rapporteurs and shadow rapporteurs of the Legal, Trade and Health committees of the European Parliament as well as the European Council for substantially improving the manufacturing waiver to deliver access to medicines for European patients.
The SPC manufacturing waiver will enable the European pharmaceutical industry to compete on a level playing field globally for manufacturing opportunities in generic and biosimilar medicines which is growing year on year.
The waiver will come into force in July 2019 and companies will be able to start manufacturing under the waiver from July 2022. The Commission has evaluated the tremendous investments in new, high-skill jobs that this manufacturing for export and for day 1 launch can deliver for Europe[1]. The waiver’s notification measures should therefore not be misused to block generic and biosimilar medicines competition.
Adrian van den Hoven, Director General of Medicines for Europe commented “Today’s vote on the SPC manufacturing waiver reflects the EU’s commitment to access to medicines, manufacturing jobs in Europe and putting EU industry on a level playing field globally. Europe has everything to gain from fully implementing the waiver to enable more competition on the pharmaceutical market and to improve its own security of medicines supply.”
Medicines for Europe has launched its vision for pharmaceutical policy ahead of the European elections. ‘Together for Health’ outlines the generic, biosimilar and value added medicines industry’s commitment to sustainable access to healthcare for all patients across Europe. The campaign is designed around four key pillars:
Commenting on the launch of ‘Together for Health’, Medicines for Europe Director General Adrian van den Hoven said “the EU elections are an opportunity to improve to healthcare across Europe. The EU can do more to ensure equitable access to medicines for patients for all Europeans. Our industry is ready to engage with the EU, national governments and stakeholders to make this happen.”
To view our policy priorities, please visit www.medicinesforeurope.com/together4health
Biosimilar medicines have significantly increased equity of access to important biological treatments across Europe and can massively improve disease management for patients with chronic conditions and cancer. They offer more prescribing options for physicians, their patients, and alleviate financial pressure on healthcare systems in an era of rapidly growing healthcare expenditure.
Biosimilar medicines can only deliver benefits for patients and sustainability for healthcare budgets in a framework that stimulates dynamic competition among multiple manufacturers. This requires governments to plan for future biosimilar medicines competition by actively removing barriers and implementing comprehensive uptake strategies based on benefit-sharing with stakeholders. Sustainable, dynamic and competitive markets are a prerequisite for a thriving biosimilar medicines pipeline and the much-needed competition of the future.
Erin Federman, Chair of Market Access Committee of the Biosimilar medicines, commented “Over the past 10 years, we have witnessed the game-changing contribution of biosimilar medicines in terms of access to treatment in auto-immune conditions and cancer care, including driving value to national healthcare systems. Now, we need governments to adopt the right policies, to foster healthier competition and create a better uptake environment to ensure the next generation of biosimilar medicines can deliver for patients.”
The SPC manufacturing waiver, which will put an end to the legal requirement to delocalise pharmaceutical production outside of Europe, was lauded as a positive step for competition and security of supply of medicines at the 15th Legal Affairs conference in Amsterdam.
Stakeholders, government representatives, lawyers and industry experts took stock of the ten year anniversary of the EU Pharmaceutical Sector Enquiry at the event. Experts expressed major concerns that patent linkage continues to be a barrier to competition and timely access to generic and biosimilar medicines in several Member States despite the clear decision 10 years ago to ban this anti-competitive practice as a conclusion of the Enquiry.
Experts also questioned why the European patent system has failed to address documented problems with patent quality in relation to the pharmaceutical sector. Failing to address this issue undermines the credibility of the system and risks delaying access to medicines.
Experts also exchanged best practice in litigation strategies to promote greater access to biosimilar medicines at expiry.
Sergio Napolitano, Legal and External Affairs Director at Medicines for Europe commented “. EU Governments rely more and more on generic and biosimilar medicines to ensure equity of access to medicines for patients. It is essential to ensure that the patent system and regulatory incentives for pharmaceuticals do not unduly delay access to medicines for patients. The SPC manufacturing waiver shows that the EU can easily tailor regulatory incentives to favour access and growth in Europe while maintaining strong incentives for the originator industry.”
A new report launched today lays out clear recommendations to boost access to value added medicines in Europe.
The IQVIA report points out the necessary adjustments to healthcare processes from defining regulatory pathways to pricing and reimbursement policies that consider value added benefits based on tailored and efficient use of evidence. The report also flags the importance of multi-stakeholder decision-making and collaboration through best in class examples such as the new pricing and reimbursement system in Belgium.
The report was presented to the European Parliament and stakeholders in Brussels, at an event hosted by Member of the European Parliament (MEP) Lieve Wierinck. Panellists from the patient community, physicians groups, nurse’s representatives, hospital pharmacists, and payers debated the way forward for better access to value added medicines for better health.
The IQVIA report cited the avenues to incentivise the development of patient-centric and continuous innovation. These pragmatic recommendations based on real case studies across Europe show that there are clear options to value continuous innovation so that it can reach patients in need.
Speaking at the launch event, Arun Narayan, Chair of the Value Added Medicines group said “Our healthcare systems must seize the opportunity of improving patient access to continuous innovation. Today, we heard the voice of the healthcare community on the need for value added medicines and the key priorities to improve the current environment. We encourage governments to recognise the need for Value Added Medicines and to benchmark the positive examples cited in the IQVIA report to enhance outcomes for patients.”
Today, the European Council, Parliament and Commission agreed a compromise deal on the SPC manufacturing waiver which will allow the co-legislators to adopt the amendment to the SPC Regulation under the current legislature.
The SPC manufacturing waiver will contribute to better patient access, to create manufacturing opportunity and jobs and to increase Europe’s capacity to manufacture and supply its own medicines. Medicines for Europe thanks the EU for addressing many of its proposals for a comprehensive waiver including the possibility to manufacture for export and day 1 launch and a balanced date of applicability. The compromise foresees a review in five years, specifically of the day 1 launch duration, which provides us with an opportunity to assess its benefits.
Recognising the complex legal nature of the SPC manufacturing waiver, we thank the many European Parliamentary, Council, Commission and national representatives who engaged thoughtfully with our industry and with stakeholders to move this legislation to a conclusion based on the benefits for Europe.
We deeply regret that the manufacturing waiver includes unnecessary and redundant notification requirements. This will require generic and biosimilar medicines manufacturers to publish commercially confidential information to allegedly prevent our industry from circumventing the rules of the waiver – notably the re-import of medicines manufactured under the export waiver for day 1 launch. This is obviously redundant now that the manufacturing waiver also authorises its use for day 1 launch manufacturing.
Medicines for Europe therefore calls on authorities to closely monitor any potential misuse of the notification system for frivolous litigation which could delay competition from generic and biosimilar manufacturers in markets where SPCs have expired.
We now call on the Parliament and the Council to rapidly adopt the SPC manufacturing waiver and look forward to strengthening Europe’s pharmaceutical manufacturing for access, jobs and growth.
The EU Falsified Medicines Directive was adopted in 2011 to prevent falsified medicines from reaching patients in Europe. Following lengthy discussions on the technical requirements to serialise between 10 and 14 billion packs of medicine every year, the system will start functioning across Europe as of the 9th February.
Prescription medicines in hospitals and pharmacies (the ‘legal supply chain’) must bear a 2-D datamatrix and anti-tampering device to enable pharmacists to verify their authenticity.
For the generic industry, which supplies over 67% of prescription medicines, this project was a massive undertaking from a manufacturing, IT and regulatory perspective. Medicines for Europe commends our manufacturers and the associations which have set up the European and national IT hubs (EMVO & NMVOs) for their incredible commitment to deliver this project on schedule. Medicines for Europe looks forward to strong cooperation with stakeholders and partners (other industry associations, wholesalers and pharmacists) to iron out the last of the technical challenges associated with this IT megaproject during the stabilisation period.
The industry funded system has required an investment of over 1 billion euros from manufacturers to update production and packaging lines and will require a further 100-200 million euros annually to maintain the IT infrastructure. These costs simply cannot be absorbed for the majority of generic medicines on the EU market. Consequently, Medicines for Europe will call on national authorities to review the sustainability of supplying Europe’s essential medicines at very low cost while having to invest in massive regulatory compliance projects like FMD.
Adrian van den Hoven, Director General of Medicines for Europe says: “Medicines for Europe congratulates our member companies, fellow industry and supply chain partners and EMVO/NMVOs for their incredible effort to make FMD operational on time. This is a massive undertaking and we are committed to stabilising this important system for patient safety with our partners over the next few months. The financial investment by our members has been astronomical and this poses a particular challenge to the sustainability of the generic medicines sector. Industry and authorities need to have a focused dialogue to ensure patient access to essential medicines is not jeopardised in the future. This kind of dialogue should urgently take place for our members to be able to support long-term sustainability of European healthcare systems and continue to deliver on better health for patients.”
Medicines for Europe calls on the European Council, Parliament and Commission to resist pressure from foreign vested interests to derail the adoption of the Supplementary Protection Certificate (SPC) manufacturing waiver. All parties involved in these discussions are well aware that these foreign vested interests fear the competition from EU biosimilar medicines manufacturers where we have been pioneers and technology leaders in bringing access to biological medicines for patients.
The purpose of the manufacturing waiver is to stop the forced delocalisation of medicines manufacturing outside of Europe while stimulating greater access to medicines at expiry of the SPC. Following thorough discussions with all concerned parties and stakeholders, the Council and Parliament have adopted sound trialogue negotiating mandates to successfully adopt the waiver within this legislature.
The Parliament’s support for EU day-1 launch stockpiling is fully consistent with the data in the Commission impact assessment and related Charles River Associates study and is widely supported by stakeholders in the healthcare community responsible for access to medicines. The same impact assessment and study evaluates the impact on the originator industry to be “0”, as originators would maintain their up-to-five years of extra monopoly after patent expiry granted by the SPC. The impact assessment states: “An SPC manufacturing waiver for export and stockpiling would be the most effective and simplest option” (EC Impact Assessment, p.105).
Medicines for Europe would like to underscore that equitable access to medicines remains a major challenge for Europe. Therefore, all policies like the SPC manufacturing waiver which can improve our economy, our security of medicines supply and more sustainable healthcare budgets should be welcomed.
Commenting on the situation, Adrian van den Hoven, Director General at Medicines for Europe stated “The SPC manufacturing waiver will bring tremendous benefits to Europe in terms of manufacturing, jobs and medicines access with no demonstrable downsides. Foreign vested interests should not be allowed to interfere in a transparent EU legislative process where all stakeholders were consulted and involved. The future of Europe’s medicines supply is dependent on this EU decision and we trust in the resolve of our democracy to do what is right for Europe.”
This table summarises the assessment made by the Commission on stockpiling at pages 46-47 of the Impact Assessment (link to impact assessment: https://ec.europa.eu/docsroom/documents/29463)
