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.”
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)
This week in London, Medicines for Europe gathers regulators and industry leaders to discuss the future of regulation of generic, biosimilar and value added medicines industries.
Our industries, which supply 67% of Europe’s medicines, face an unprecedented set of regulatory challenges in the year ahead. With less than two months to adapt to the UK withdrawal from the European Union, we renew our calls for a clear contingency plan. Pragmatic solutions are needed to avoid medicine supply disruptions as companies finalise the process of separating UK and EU activities. New regulatory requirements including the Falsified Medicines Directive and extended requirements for environmental risk assessment need to be implemented thoughtfully in partnership between industry and regulatory authorities. This will help avoid disproportionate impacts on essential medicines that the majority of European patients rely on.
The EU must seize the opportunity to lead in international regulatory cooperation for the global development of complex medicines. Similarly, the EU’s ability to align with partners such as the US Food and Drug Administration (FDA) on Good Manufacturing Practice (GMP) mutual recognition offers the possibility to strengthen the oversight of global manufacturing supply chains. Digital tools like electronic patient information leaflets (‘e-leaflet’) need to be leveraged to improve the flow of information to patients and eliminate the vast complexity of updating paper leaflets in over 20 languages across the EU.
Marc Alexander Mahl, Medicines for Europe President commented: “The dialogue between industry and regulators to optimise the regulation of pharmaceuticals is an essential part of access to medicines. We need to take material steps forward to grasp the opportunities in areas like e-leaflets and global development while carefully managing disrupters such as Brexit. ”
National authorities, regulators, industry leaders, and stakeholders gathered in London to discuss the role of pharmacovigilance in ensuring patient safety and access to safe medicines at the 12th Medicines for Europe Pharmacovigilance Conference.
As we move into an increasingly patient-centred future, simplification and improved communication should be at the heart of our pharmacovigilance strategy.
Digital technologies offer the promise of more pharmacovigilance data from different sources provided we can improve the capacity of the EMA pharmacovigilance system to better filter essential and non-essential information sent to companies for review. The EMA-industry dialogue should step up its efforts to streamline the functioning of the system.
Our industry also applauds the introduction of patient hearings which provide patients with a platform to share their views and contribute to better pharmacovigilance. This patient voice combined with targeted data will improve communication between industry, regulators, healthcare providers and patients in the future.
Adrian van den Hoven, Medicines for Europe Director General commented: “Efficient pharmacovigilance is paramount for the safe use of medicines. Industry and regulators have a shared responsibility to ensure that this system remains effective and efficient. We commend the regulatory community on the close cooperation to achieve results for patients who rely on medicines. We need to accelerate the use of structured data to streamline and focus pharmacovigilance systems on patient needs. Patient and healthcare practitioners are welcome contributors to this process.”
Medicines for Europe welcomes the publication of the European Commission Report on Competition Enforcement in the Pharmaceutical Sector (2009-2017).
This compilation of pharmaceutical competition law cases is part of the Health Council Conclusions of June 2016 on strengthening the balance in the pharmaceutical systems in the EU. These conclusions aim to ensure the timely availability of generic and biosimilar medicines for patient access and sustainable pharmaceutical budgets.
The report provides valuable information on how to prevent unnecessary and unlawful delays to generic and biosimilar medicines competition. Competition law scrutiny is essential to prevent misuse of the regulatory system to delay competition including the spread of misleading information to denigrate generic and biosimilar medicines in the market.
Adrian van den Hoven, Director General of Medicines for Europe, commented: “Today’s report shows the important role that competition rules play in the pharmaceutical sector. Building on the excellent work of the EC Sector Inquiry of 2009 and the results of this Report, Medicines for Europe is ready to support the European Commission and national competent authorities in removing barriers to proper competition (such as patent linkages or disparagement practices) and focus on policies and incentives to stimulate more competition in the off-patent sector. This is going to result in better access for patients and sustainable healthcare systems throughout Europe.”
Medicines for Europe welcomes today’s vote of the Legal Committee of the European Parliament (JURI), which combines the opinions of the Health (ENVI) and Trade (INTA) committees in support of a comprehensive SPC manufacturing waiver.
The compromise agreement by the JURI Committee includes the possibility to produce generic and biosimilar medicines during the SPC period for export purposes and to stockpile for two years to prepare for launch in the EU on day-1 after SPC expiry. This will stop the forced delocalization of pharmaceutical manufacturing outside of Europe and is a positive step forward to allow all manufacturers including SMEs to benefit from the manufacturing waiver. More importantly, patients and member states’ healthcare budgets will benefit from immediate access to generic and biosimilar medicines manufactured in Europe as soon as SPCs expire. The Parliament’s position is fully justified by the European Commission Impact assessment which underlines “an SPC manufacturing waiver for export and stockpiling would be the most effective and simplest option”.
The JURI committee also voted to implement the SPC manufacturing waiver starting in January 2021. While there is further room for improvement, this represents another step in the right direction to ensure that the SPC manufacturing waiver delivers on its promise of industrial jobs and lower costs for patients and healthcare systems.
The JURI committee also recognises the importance of protecting the right of manufacturers to keep commercially sensitive information confidential in the context of the notification procedure. We hope this common sense approach will be reflected in the final text of the SPC manufacturing waiver. However, we do not understand the logic of including falsified medicines requirements – which are for patient safety – into an EU regulation on pharmaceutical incentives.
Medicines for Europe Director General, Adrian van den Hoven, commented: “The Parliament has made a thorough review and introduced many positive changes to the SPC manufacturing waiver proposal. With some further fine-tuning of this text in the trialogue phase, the SPC manufacturing waiver will deliver on its promise for patient access, for pharmaceutical manufacturing jobs, and for sustainable healthcare budgets in Europe.”