“We believe that by working together and sitting around the table, post-COVID, Europe can achieve both of these ambitions,” said Nathalie Moll, the director-general of the European Federation of Pharmaceutical Industries and Associations (EFPIA).

She added that EFPIA members are working around the clock to find vaccines, diagnostics and treatments to use in the fight against coronavirus.

“Scientists are working tirelessly to speed up the development of new vaccines and we will keep working with regulators in order to avoid delays. We estimate it is going to take 12-18 months at the minimum to have a registered vaccine on the market,” she said.

Nathalie Moll provided emailed replies to EURACTIV’s Sarantis Michalopoulos.

We see a growing number of EU countries shutting their borders to halt the coronavirus spread. Although all say medical products will be safeguarded, could their supply be affected in the event of a total suspension of Schengen?

As an industry, we are focused on ensuring the supply of medicines to the patients that need them.

To support this critical objective, EFPIA warmly welcomes this week’s adoption by the Commission and Home Affairs Council of a range of measures aimed at maintaining the free circulation of medicines around Europe. The measures include:

• Preservation of the free circulation of all goods. In particular, guaranteeing the supply chain of essential products such as medicines, medical equipment, essential and perishable food products and livestock.
• No restrictions imposed on the circulation of goods in the Single Market, especially (but not limited to) essential, health-related and perishable goods, notably foodstuffs, unless duly justified.
• Designated priority lanes for road-freight transport (e.g. via ‘green lanes’) and consider waiving existing weekend bans.
• Enabling transport workers, to circulate across borders as needed.

With Europe now at the epicentre of the coronavirus pandemic, there are perpetual challenges in getting medicines to patients across Europe, challenges that EFPIA member companies are meeting head-on. Members continually monitor their supply chains and contingency plans as well as liaising with the Commission, the European Medicines Agency (EMA), member states and their competent authorities to address issues as they arise with pragmatic approaches that put patient needs first.

EFPIA is in constant dialogue with the authorities through weekly calls with Health Commissioner Kyriakides, Commissioner Breton and Commissioner Lenarčič, together with representatives from across the medicines and medical devices supply chain. In addition, 18 March 2020 saw the first meeting of the EU Executive Steering Group on shortages of medicines caused by major events, convened by the Commission, the EMA, member states and their competent authorities to “discuss measures aimed at addressing the impact of the outbreak of COVID-19 on the supply of medicines in the EU”.

We continue to monitor the situation closely and we will keep an open and constant dialogue with the European Medicines Agency and the European and national authorities via weekly calls with the EU Executive Steering Group.

How close is the EU pharma industry to finding therapy and ultimately a vaccine for the coronavirus?

As an industry #WeWontRest in fighting COVID-19. EFPIA members are working around the clock to find vaccines, diagnostics and treatments to use in the fight against coronavirus. We are committed to working collaboratively across the research and healthcare communities, utilising our world-leading science, people and resources to tackle this outbreak.

There are significant efforts underway to diagnose, treat and prevent infections from the virus. Companies have donated compounds with the potential to treat coronavirus for emergency use and clinical trials, including compounds formerly tested on other viral pathogens such as Ebola and HIV.

Others are researching vaccine candidates and undertaking inventories of research portfolio libraries to identify additional potential treatments for R&D. Companies are also exploring ways to leverage existing technologies that provide the ability to rapidly upscale production once a potential vaccine candidate is identified.

There are several ongoing clinical trials (82 clinical trials planned or pending worldwide on 16 March 2020), with three already occurring in the European Union.

Thirteen companies have responded to IMI Call 21, sharing compounds and assets from their libraries in a collaborative bid to accelerate the development of therapeutics and diagnostics to tackle the current and future outbreaks of coronavirus.

How much time will it take to be on the market? VDL said it could be ready before Autumn, is it a realistic scenario?

Companies are accelerating their programmes to develop a vaccine for COVID-19 as quickly as possible. EFPIA medicine companies and vaccine developers have deep scientific knowledge gained from decades of experience with similar viruses such as MERS, SARS, influenza, HIV and Hepatitis C. This knowledge dramatically improves our likelihood of success in developing an effective vaccine and identifying existing treatments for those infected. EFPIA member companies are now working around the clock to see use this knowledge and any likely vaccines or medicines in development can be used in the fight against COVID-19.

Before a new vaccine is approved for release on the market, a rigorous regulatory procedure to assess quality, efficacy and safety must be undertaken. Vaccine development is a complex and time-consuming process that differs from the development of conventional medicines. Vaccines are subject to even tougher standards than medicines because vaccines are given to millions of healthy people as they are intended for use in healthy individuals as a preventive measure whereas conventional drugs are aimed at the treatment of a condition. Vaccine clinical trials focus on demonstrating prevention of a disease which implies that a higher number of subjects will be required than for traditional drug trials.

Scientists are working tirelessly to speed up the development of new vaccines and we will keep working with regulators in order to avoid delays. We estimate it is going to take 12-18 months at the minimum to have a registered vaccine on the market.

In the aftermath of the crisis, what do you think will change when it comes to healthcare in Europe? Should member states ask for more EU responsibilities when it comes to health?

When something as significant as this pandemic happens right across Europe, I am certain there will be lessons to learn, things we can do differently, things that we can do better. What I think will be important is to look holistically and collaboratively at Europe’s response and learn the lessons together across the public and private sectors, across the European Institutions and across member states.

In light of the coronavirus developments, the discussion over the much-awaited EU pharmaceutical strategy is expected to be heated up. How do you expect from the EC to handle this? And what does the industry want?

Our first thoughts are with all those affected by the coronavirus pandemic. As an industry we are committed to working collaboratively across the research and healthcare communities, utilising our world-leading science, people and resources to tackle this outbreak. Our priorities during this time of crisis for Europe is to ensure the safe supply of medicines to the patients that need them, to research and develop new vaccines, diagnostics and treatments for use in the fight against COVID-19 and to partner and support organisations on the ground to fight against COVID-19.

We laid out our contribution to the debate around the Pharmaceutical (and Industrial) Strategy at the start of the March. For me, it’s more about what kind of medical research ecosystem Europe wants to foster in order to be able to manage our healthcare more broadly including crises like this one. We need policies in place that can create and support that research ecosystem in the long run as well as ensure access to medicines to the patients that need them in a way that is sustainable for health systems today and tomorrow.  We believe that by working together and sitting around the table, post-COVID, Europe can achieve both of these ambitions.

During this crisis, many criticised the lack of preparation of EU healthcare systems to address this critical situation. Do you think it’s time for a strong and permanent deal between the pharma industry and the public sector to avoid similar situations in the future?

Actually I have been heartened and encouraged by the level of collaboration and communication across industry, across the life-science sector, with regulators and the European Institutions.  There has been a constant dialogue and collective action to put the needs of patients at the fore.  This way of working is a strong signal of what can be achieved by working together.

[Edited by Zoran Radosavljevic]