To maintain its leadership in pharmaceutical regulatory science, the EU should integrate digital tools in the regulatory process. Delivering results on digitalisation, updated variations procedures, streamlined development processes and medicines availability are clearly within the pharmaceutical mission of the recently appointed European Commission and are clearly aligned with the access objectives of the EMA-HMA regulatory science strategy.
Evidence compiled in a report further confirms the need to adapt the EU variations system to modern IT tools. Integrating effective IT systems and programmes into the EU variations legislation would enable a more efficient use regulator and industry resources and a stronger focus on what really matters to patients.
As part of a wider commitment to improve access to medicines in Europe and globally, the conference tackled the need for a framework for the global development of generic medicines. By moving to common science-driven standards with other highly regulated regions, industry will be able to streamline development and promote access, while avoiding scientifically unnecessary (and sometimes unethical duplication of) clinical studies.
Recognising the shared industry and regulatory objective of ensuring the supply of medicines, the conference focuses on tackling the root causes of medicines shortages as well as the interim measures needed to mitigate supply problems.
Christoph Stoller, Medicines for Europe President commented: “The political objective for health is clear: Europe must have an adequate and sustainable supply of affordable medicines to meet public health needs. Our industry is a key partner to achieve these goals, currently supplying almost 70% of prescription medicines in Europe. Regulatory affairs can contribute significantly to these objectives by capitalising on digital technology and by making optimal use of the scientific resources of regulators and industry.”
A smart digital pharmacovigilance system should:
Medicines are developed and manufactured to help patients so, it is important to monitor their use for potential adverse events through pharmacovigilance.
At the 13th Annual Medicines for Europe Pharmacovigilance Conference, stakeholders agreed that pharmacovigilance is not only mechanical exercise in regulatory compliance. Rather, smart pharmacovigilance should allow us to leverage the experience of the European Pharmacovigilance System, including the longstanding knowledge of the safety profile of well-established products and big data to optimise the use of our finite human resources.
Big data and globalisation offer opportunities to innovate in the pharmaceutical sector. Innovation also means finding new ways of making existing drugs and processes like pharmacovigilance deliver more for patients. Digital technologies increase available pharmacovigilance data, but this can only be put to good use if essential and non-essential information is filtered by the EMA pharmacovigilance system before review.
By building on successful industry-regulator cooperation projects such as the HaRP project for risk management, we can dramatically improve synergies in other areas like electronic product information or streamlining communication with healthcare professionals.
Adrian van den Hoven, Medicines for Europe Director General commented: “Europe has one of the most sophisticated pharmacovigilance frameworks in the world. But we should not rest on our laurels. Smart pharmacovigilance requires us to improve our capacity to filter the massive information available so that we can focus on what matters most to patients.”
Christoph Stoller, the President of Medicines for Europe, led an important mission to Bulgaria to improve access to medicines in partnership with the Bulgarian Generic Pharmaceutical Association chaired by Nikolay Hadjidontchev. Bulgaria has limited public funding for medicines and patients face the highest drug co-payment costs in all of Europe according to the State of Health in the EU report. To address this challenge, Medicines for Europe met with the Bulgarian minister of Health Kiril Ananiev and with the Chair of the Health Committee of the Bulgarian National Assembly Dr. Daniela Daritkova on 10 December in Sofia. During the exchange, our President underlined how EU pharmaceutical policy under the new Commission should help Bulgarian patients.
Regarding shortages and availability, Medicines for Europe warned that Bulgaria should not apply clawback taxes to generic and biosimilar medicines which are the main driver of access in the system through lower prices for both the national health fund and patient co-payments. He underlined that similar measures in Romania led to 3000 medicine withdrawals and major availability problems as was highlighted by the European Commission (citation DG ECFIN). Recent EU documents such as the Euripid guidance document also advise countries not to apply external reference pricing to generic medicines as this leads to a double price cut (first a reduction of the originator reference price, then a reduction of the legally lower generic medicine price), therefore Bulgaria should prioritise measures such as rational prescribing to ensure greater volume usage of generic medicines to increase access and ensure the stability of the national health fund. Finally, the President made a strong case for a dynamic biosimilar medicines policy. Bulgaria has very low levels of access to biological therapies (3rd lowest in the EU) – including to important cancer and immune therapies. By encouraging uptake of biosimilar medicines through competitive procurement in hospitals and benefit sharing measures for physicians and patients for medicines dispensed in a retail setting, Bulgaria could dramatically increase access to essential biosimilar medicines for Bulgarian patients.
Christoph Stoller said: Medicines for Europe will be a partner for the Bulgarian government to play an active role in EU pharmaceutical policy and to implement strong generic and biosimilar medicines policies as recommended by the European Commission and OECD in the State of Health in the EU report. Together, we can improve access to medicines for all Bulgarians through stepwise improvements to pharmaceutical policy at EU and national level. Our industry is committed to deliver on equity of access to medicines and calls on the Commission to provide technical support to Bulgaria to help it achieve real progress for public health.
The European Commission has identified the use of generic and biosimilar medicines as crucial for EU health systems in a report released today.
Detailing the potential benefits of generic and biosimilar medicines use, the European Commission identified the urgency to foster the use of biosimilar medicines specifically, an urgency heightened due to the expenditure rate on biological medicines.
Of concern in the report findings were the fluctuations of generic and biosimilar medicines use across EU member states, even though greater competition has a known track record in improving access to safe and effective medicines in health systems across Europe.
Generic and biosimilar medicines were also identified as cornerstones of appropriate use of medicines in the hospital setting. While trends show that hospital pharmaceutical spending is increasing, the benefits of generic and biosimilar medicines use are vital to ensure efficient care.
Speaking on the findings of the report, Medicines for Europe Director General, Adrian van den Hoven commented “The launch of the 2019 State of Health in the EU report reinforces the opportunities brought by generic and biosimilar medicines to improve equitable and sustainable access. We see all over Europe that health systems are struggling to deliver efficient care, while pharmaceutical budgets continue to spiral. Our hope is that EU and national policies seize these opportunities and develop better policies to ensure generic and biosimilar medicines use. This ultimately will enhance the functioning of health systems in Europe and deliver on patient access.”
Value added medicines deliver sustainable and continuous innovation with existing molecules and enhance patients’ well-being.
The 3rd Value Added Medicines Conference brought together thought leaders to discuss the future of digital delivery and the regulatory and market access framework for value added medicines, to help tackle chronic diseases and an ageing population
According to IQVIA, value added medicines have grown 1% in volume in the EU over the last year[1],[2], and many more initiatives are needed for improving patients’ access to value added medicines. During the conference, a multi-stakeholder exchange of ideas identified clear next steps to improve patients’ access to value added medicines:
Speaking at the conference, the Chair of the Value Added Medicines Sector Group at Medicines for Europe, Arun Narayan, commented “The number of people over 80 will double by 2050, rising from 4.7% to 11.3% across 27 EU members[3]. Governments will be more challenged to deliver high-quality care due to rising demand and the physical and mental challenges associated with ageing and value added medicines provide one solution. Within 18 months of the introduction of a pricing and reimbursement legislation in Belgium that supports value added medicines, more Belgian patients are benefiting from safer and more convenient value added medicines. We urge EU governments to adopt the Belgian approach and seize the benefits of continuous improvements to transform health care”
Medicines for Europe President, Christoph Stoller, added “Patients must sit at the heart of the digital health revolution. There are clear and significant benefits to be gained. We have discussed the opportunities ahead – how to make the most of the digital health revolution so that patients can be the ultimate beneficiaries from such continuous innovation. Our ambition as value added medicines manufacturers is to contribute to a healthier society bringing tailored solutions to patients, healthcare professionals and healthcare systems. Today’s conference is a crucial milestone in creating the right environment for value added medicines in Europe.”
The Value Added Medicines sector group instituted two awards for projects that bring value added solutions to patients. The winners of the 2019 awards were:
Winner category ‘Initiatives/campaigns that aim to improve patients’ quality of life and/or adherence and/or demonstrate relevant value added benefits on existing treatments’:
Project ‘Psoplus, A Patient-Centred Consultation Programme For Patients With Psoriasis’, Elfie Deprez
Winner category ‘Scientific research/projects led by academics/healthcare professionals/developers that aim to improve existing treatment adherence and/or convenience and/or patients’ preferences and/or demonstrate relevant value added benefits for patients.’
Project ‘MASK digital anamorphosis: Digital transformation of health and care in airway diseases from research to practice and value added medicines’, Prof Dr Jean Bousquet
[1] IQVIA. Midas database. 2019.
[2] Prescription market
[3] https://www.oecd-ilibrary.org/social-issues-migration-health/ageing_9789264242654-en
