Out-Law Analysis | 22 May 2020 | 4:27 pm | 5 min. read
However, senior industry figures have warned that the solutions that both originators and generic medicine manufacturers have relied upon to meet an unprecedented surge in demand for ICU medicines, such as anaesthetics and muscle relaxers, may not be sufficient or potentially available at all to meet a potential second wave of the virus on the continent.
At a webinar event hosted by Pinsent Masons, the law firm behind Out-Law, Adrian van den Hoven and Sergio Napolitano, director general and general counsel at Medicines for Europe respectively, and Kristine Peers, general counsel at the European Federation of Pharmaceutical Industries and Associations (EFPIA), united in their calls for policy makers and the pharmaceuticals industry to come together to plan now for how to meet a second-wave demand for medicines.
The call comes at a time when some of the restrictions that were designed to curb the spread of the virus to-date are beginning to be eased by European leaders.
During the webinar we heard how parts of Europe saw a surge in demand for ICU medicines during February, March and April as coronavirus, officially Covid-19, began to take grip. In Italy, the industry reported having never seen a demand surge like it before, while in France it was estimated that hospitals would need three to four years' worth of ICU medicines stock to deal with the emerging situation at the time.
Before the demand surge hit, it had been the issue of supply that had concerned industry most, as China had shut down production sites in light of its own problems in managing the spread of the virus. Contingency plans were activated to address the reduced production and logistics bottleneck, although more recently products exported from Europe to China have been able to be re-importing to boost supply.
As industry began to recognise that no one European country could manage the crisis alone and that a coordinated effort from industry across the continent would be needed to address the emerging risks, Medicines For Europe and EFPIA came together to try to get a better picture of the demand surge in different countries and also to find ways that industry could scale up supply. Special modelling was established to estimate demand and consumption of ICU medicines for each country.
Companies are working around the clock to ensure the supply of medicines to patients that need them and have been increasing production by as much as 260% in some cases. This is necessary in response to the enormous increase in demand for some medicines, next to stockpiling and export bans by national governments. As a result of the high level dialogues Medicines for Europe and EFPIA have with the European Commission and European Medicines Agency (EMA), a number of challenges have already been largely overcome related to the supply of essential medicines; however, export restrictions still remain. All the evidence suggests that there is not a supply problem but rather an allocation challenge, with no clear picture on what is likely to be needed one, two or three months from now.
Medicines For Europe worked with the Commission to secure a so-called 'comfort letter', which freed companies willing to participate in the coordinated effort to provide commercially sensitive data, through an independent consultant, for the purposes of supporting the programme of demand and supply modelling for ICU medicines, without the fear of being pursued by the Commission or national competition authorities for breaching competition rules, subject to the activity being carried out within strict parameters.
The safeguards included ensuring that the exchange of confidential information in a non-aggregated way was only done within a "controlled forum", and only if objectively necessary to meet the clearly stated objectives. Non-disclosure agreements had to be signed, and decisions taken and any possible arrangements put in place had to be done in full sight of the Commission, with minutes from meetings taken and shared with the regulator. Time limits in place ensure the unprecedented levels of collaboration do not continue beyond when is necessary to address the public health emergency.
The modelling undertaken and the measures implemented by pharmaceutical manufacturers helped to assess and ensure the security of supply of vital ICU medicines during Covid-19's initial surge across Europe.
However, the clear message from the industry is that a fresh plan is needed now to address the potential impact of a second wave of the virus. This is because, they warn, the situation could be different.
Firstly, as Covid-19 is now a truly global pandemic, it means the ability of European manufacturers to tap into supplies from other parts of the world, as they were able to during this initial phase, may not be possible during a second wave. Re-importing may not be possible, and real challenges arise in replenishing not possible perhaps and also need to replenish Europe's stock of active pharmaceutical ingredients (APIs) which have been run down during the ongoing supply surge.
In any event, modelling for a second wave is much more challenging as countries take different approaches and move at different paces to easing lockdowns and getting economies back up and running, with the risk that doing so will expose more people to the virus.
Modelling for a second wave is much more challenging as countries take different approaches and move at different paces to easing lockdowns and getting economies back up and running, with the risk that doing so will expose more people to the virus.
Some countries are also imposing export bans and/or hoarding stocks, putting equity of access to medicines at risk. The flow of essential supplies across borders could be disrupted as a result of this, making it harder for industry to help with getting the right products to the rights hospitals at the right time.
Targeted competition and regulatory relaxations will need to be maintained to ensure industry can coordinate where needed, and that production levels can be bolstered to meet another demand surge. Yet, new financial mechanisms will need explored if manufacturers are to be expected to sustain factories with larger capacity than is needed for normal market demand given that the commercial model entailed in this is unsustainable.
These fresh challenges require a shared plan by government and industry.
The longer term impact on the way that Europe's pharmaceutical companies operate will be shaped by the fallout from the Covid-19 crisis.
We can expect biopreparedness to be higher up the political agenda and for this to be reflected in how industry is readied for another health crisis. Europe's strategic autonomy is on the forefront of the EU's agenda, with the potential for supply chains to be shortened and more localised. Some procurement systems – which favours just one manufacturer supplying products into distinct regions – could also be revisited to boost competition and potential production levels.
However, while lessons will be learned from the Covid-19 pandemic, the blueprint for managing a public health emergency will not be suitable for delivering new treatments required in the future.
Flexibility in the competition regime is unlikely to be granted to support the development of treatments for coronary diseases, for instance, and while fast-track procedures might be developed to better support and incentivise the development of new antibiotics, for example, rules on safety and efficacy will remain paramount and will restrict just how far regulatory relaxations can go.
A robust European ecosystem for research and development (R&D) will remain essential, underpinned by a fair intellectual property rights framework that protects investment in medical research and allows Europe to meet the challenges faced by patients and health systems, competing with other regions like China and the US in the development of new medical technologies. New mechanisms for incentivising R&D could be explored, perhaps to encourage more repurposing of existing molecules as much as the development of entirely new products.
These are some of the issues which governments, regulators, industry and patient groups will need to reflect on when the Covid-19 crisis eventually subsides. We are keen to hear from others in the industry on this topic and to continue to foster discussion in future articles and webinars.