COVID-19 represents an unprecedented challenge for global health systems in modern history. The implications are wide-ranging and include: Legal e.g. incentives review, policies, directives and postponement of legislation; EMA guidance on clinical trials; Shortages of medicines; counterfeit medicines; EMA priorities; and National measures.
COVID-19 has changed almost everything in the EU pharma policy landscape, whereby postponements have occurred relating to Pharmaceutical Strategy, the EU cancer plan & potentially also the Incentive Review. There is a clear policy priority on securing supply in medicines and/or devices and eventually a vaccine. Many Member States are discussing claw back mechanisms, while the EU discusses Joint Procurement as a way to reduce the budget impact of new medicines. From a manufacturing perspective, the Commission will try to get production back to the EU, which is not an easy task as there are reasons why manufacturing has moved to China and India in the past (high production cost & low margins, especially due to tenders for generics in Europe).
Regarding the impact on clinical trials, there are ongoing discussions between Commission, EMA, national competent authorities and industry/sponsors, which has led to a regular update being available on the EMA website: https://www.ema.europa.eu/en/news/guidance-sponsors-how-manage-clinical-trials-during-covid-19-pandemic.
Shortages of medicines and devices is becoming a priority topic ranging from personal protective equipment and ventilators, to paracetamol and various ICU medicines. Discussions are ongoing at EMA and Commission level, involving weekly calls between the EMA, Commission and industry. This has amplified the need to support bringing active pharmaceutical ingredients back to the EU, despite the abovementioned challenges of cost.
Some legislation has been delayed, such as the Medical Device Legislation, which has been pushed back one year until 26 May 2021. It is rare for such a postponement to be agreed, especially in such a short period of time. In the meantime, the IVD and Medical Devices Directives continue to apply.
Finally, some new challenges emerge due to the pandemic. Internet pharmacies and the internet more broadly is increasingly used while some bricks and mortar pharmacies are closed, which inevitably increases the risk of exposure to falsified medicines. The falsified medicines directive only partly addresses the issue, as logos are required for legal internet pharmacies. EU coordination is needed to support COVID-19 treatments and vaccines, which is a priority topic for the EMA and commission, with emergency/accelerated procedures emerging.
As on the European level, COVID-19 is understandably the focus of all health agencies and, while there is a sense of openness to collaboration with industry, this is primarily relating to COVID-19. Non-urgent care and/or treatment is being delayed, which is likely to have a knock-on impact on treatment initiation and patient outcomes. In turn, due to front line staff being pulled away from national assessments of technologies, the introduction of new treatments in health systems will be late due to HTA delays. This also means reduced engagement opportunities with healthcare professionals and patient group representatives for advisory boards and general advice, so companies have to be very clear and concise in engaging with such experts. Parliamentarians and decision-makers are largely unavailable in the short term, although we are likely to see a ‘new normal’ emerge as they change focus. Some elements of these topics are summarised below:
• UK HTA and pricing implications versus Germany HTA and pricing implications
• Versus the remainder of EU5.
In France, Italy and Spain, there are inconsistent reports of keeping to schedule with appraisals, where some delays are emerging and national bodies attempt to continue virtually; of particular note is that EunetHTA will prioritise resources to be used in their various national settings in order to respond to the current emergency on COVID-19, therefore, Assessments or Early Dialogues might face delays or suspension of new requests (https://eunethta.eu/eunethta-response-to-covid-19/)
The introduction of new treatments mean that focused communication is even more important to prioritise and expedite processes i.e. ensuring that the right person is approached at the right time with the best information. Forced delays to patient access provides one advantage to companies, which is additional time to plan strategies, so that they can develop the ‘best information’. In addition, deals may be explored to support timely patient access, although authorities are focussed on COVID-19 in the immediate term, so scoping deals with favourable terms to recognise expediency will be important. Finally, treatment in the patient’s home via homecare services becomes even more attractive to health systems, as a way to increase social distancing.
Responses to COVID-19 on the national level may result in increased demand for health innovation to meet the needs of health systems due to disruption and delay in patient care, thereby leading to backlogs in the care pathway, and patients presenting at a later stage than before the pandemic. This has reportedly happened in the UK in cancer care, whereby almost no cancer surgery has taken place for over eight weeks during the lockdown, and it may be July until normal surgery and care can resume, which means patients are at a later stage of disease when they have surgery, with poorer outcomes expected. New models for collaboration are emerging and could become a new normal e.g. the Office for Life Sciences offers of support to companies entering the UK, and Regulatory and HTA agencies are supporting COVID-19 efforts where feasible. Some particular challenges result from UK/EU and US trade talks being scaled down, and the UK Government is not extending Brexit talks, so industry associations are working hard to support the availability and consideration of facts in negotiations. Putting all this in context of reallocated resources means that pricing pressure is very likely to result as drug/device prices are often the first place to go for savings.
Companies should focus on five key areas:
1. Improved data including real world evidence to support HTA submissions. This should be based on a careful assessment of the value of new information and HTA trends, so that activity can be targeted to the areas of most benefit, to support pricing and reimbursement negotiations
2. Considering what the new normal might be like for patients, e.g. independent patients at home
3. Location of manufacturing facilities and backup solutions in case of a resurgence of the pandemic, or indeed the emergence of new ones, thereby changing their reliance on one country or region
4. Meeting unexpected demand due to changes in healthcare and mitigating clinical governance impact, such as delayed care leading to later stage disease, which may result in greater morbidity and mortality
5. Collaboration to support Regulatory/P&R agencies with making prioritisation decisions
MAP BioPharma can help you navigate the complexities of this environment so do get in touch if you would like a free 30-minute consultation to discuss how we can help. Email on firstname.lastname@example.org or phone us on
+44 (0) 1480 832360.
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