A smart digital pharmacovigilance system should:
Equitable and sustainable access to medicines is a concern across the EU. Policy reforms were discussed during the seminar “A European Union that ensures Patient Access & Sustainability”, organised by the Hungarian Permanent Representation to the EU with the support of the Croatian Presidency of the European Council. The seminar assembled high-level experts from the European Commission, OECD, health economists and representatives from different health care stakeholders.
According to the WHO, cancer is responsible for 20% of deaths in Europe[i]. With more than 3 million new cases every year which is expected to increase to more than 4.3 million by 2035[ii].The Beating Cancer Plan should overcome access barriers to existing oncology treatments in all EU member states. Generic and biosimilar medicines offer valuable opportunities for expanding access to oncology treatment for patients, while delivering efficiency to health systems. A well-designed EU cancer plan cannot conceivably succeed without robust policies for generic and biosimilar medicines use.
Reports of medicines shortages are increasingly prevalent in Europe. Ensuring the availability of essential medicines should be an EU priority. The EU should tackle the economic and regulatory root causes of shortages and establish a pan-European mechanism to coordinate EU and national policies to reduce the risk of shortages and to avoid spill over effects through which one country’s policy would create supply issues in another. Preventing supply issues becomes especially pertinent considering the ongoing COVID-19 outbreak globally.
Among the measures discussed were guidelines on medicines procurement under the EU Procurement Directive, including how to acknowledge investments in manufacturing and supply security for Europe, supported by strong industrial and competitive policies to stimulate investment for the benefit of European patients.
Christoph Stoller, President, Medicines for Europe, concluded his opening remarks by calling for a “focused, action-oriented high-level pharmaceutical forum, so that all together, policy-makers, regulators, payers, industry and other stakeholders concerned can achieve the right balance between health objectives and industry competitiveness in Europe. Europe can only succeed by breaking down silos to jointly define and implement policy reforms in support of patient access to medicines”
[i] http://www.euro.who.int/en/health-topics/noncommunicable-diseases/cancer/cancer
[ii]https://ec.europa.eu/info/horizon-europe-next-research-and-innovation-framework-programme/mission-area-cancer_en
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.
