The European Medicines Agency (EMA) has published today a press release to address concerns about the use of ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDs) in COVID-19 patients.
According to the Agency, when starting treatment for fever or pain in COVID-19, patients and healthcare professionals should consider all available treatment options including paracetamol and NSAIDs. Each medicine has its own benefits and risks which are reflected in its product information and which should be considered along with EU national treatment guidelines, most of which recommend paracetamol as a first treatment option for fever or pain.
In line with EU national treatment guidelines, patients and healthcare professionals can continue using NSAIDs (like ibuprofen) as per the approved product information. Current advice includes that these medicines are used at the lowest effective dose for the shortest possible period.
The agency also highlighted that there is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID‑19. EMA is monitoring the situation closely and will review any new information that becomes available on this issue in the context of the pandemic and has committed provide further information as necessary and once the PRAC review is concluded.
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.”
