Interview 2: Adrian van den Hoven, Director General of Medicines for Europe

Medicines for Europe represents the generic and biosimilar sector, and the companies who supply almost 70% of all medicines in Europe.

Prior to joining Medicines for Europe, Adrian van den Hoven was Deputy-Director General of BUSINESSEUROPE where he was responsible for the International Relations department.  He previously worked as an International Relations researcher and an adjunct professor in Italy (EUI), France (Nice) and Canada (Windsor). Adrian is currently locked down in Brussels with his family.

We are hearing about shortages of medicines in Europe, how big a problem is it and what is your sector doing to address it?

Yes, what you are hearing is something very unusual. It’s not what you would normally consider a shortage where say a production site has a fire or a manufacturing problem and they cannot supply the market. In this case, we are experience very large demand surges for medicines – demand surges never experienced before. The explanation for this is that many thousands of people across Europe are infected with Covid-19 and many patients develop respiratory problems as a result. Those patients then need to go to intensive care and be placed on some form of mechanical ventilation to help them breathe. This, in turn, requires a very large volume of medicines to use those ventilators – medicines like sedatives, pain medicines, etc. because these patients stay on ventilation for a long time (14 days on average). We have never seen such a high demand for these medicines. It’s totally off the map.

To address this situation, we have created a special group of companies that produce these medicines for intensive care and are estimating the demand (the number of patients and how much they are expected to consume) and are collecting data via a consultancy (Kearney) on the total supply for Europe to see if the demand/supply match. If there is undersupply, we will take action on this. This is not a common process and in fact the Commission has recently adopted a  Decision to recognise this project and has granted a competition law “comfort letter” to us for this project. In practice, this means that the project needs to share all information with the Commission and that certain information exchanges need to be done inside a new Commission Forum. This is pretty new and a major learning process for our industry and for the Commission. It’s what you might call a “first”.

The commission decision is here: https://ec.europa.eu/commission/presscorner/detail/en/ip_20_618

What role will medicines play in beating Covid-19 together with vaccines, diagnostics and other healthcare solutions?

Some of our members are developing diagnostics and vaccines or medicines for Covid-19. In addition, some existing medicines (hydroxychloroquine or lopinavir/ritonavir) are currently under clinical trial in the EU or the WHO to test their efficacy for Covid-19. Our members have donated these medicines for the clinical trials (basically to hospitals) in line with our ethics rules on donations. We need to wait for the results of these trials (a few more weeks) to understand how useful these medicines can be for patients with Covid-19 infections.  If the clinical trials demonstrate efficacy for Covid-19 infections, there will need to be a regulatory step and then manufacturing to supply the medicine to patients.Watch this space in 1 or 2 months, I would say.  The development of a vaccine or a new medicine will take a lot longer – probably 9-12 more months.

What is the impact of Covid-19 on the medicines sector overall?

The impact is huge. First, there are large demand surges for medicines needed for patients infected with Covid-19 (especially intensive care medicines) as well as for more commonly used medicines (chronic disease medicines, paracetamol) as patients have received extended prescriptions to reduce their visits to doctors/pharmacies. Manufacturers are therefore heavily engaged to produce the medicines and to get them to the countries that need them.

This is doubly challenging because Covid-19 is complicating the normal course of business for our manufacturers. First global supply chains are under stress for the last few months. China, which is a major producer of starting chemicals, shut down an important part of its industry over the last few months. In Europe, we have to manufacture under lock down rules (which requires special licences to allow people to go to work in factories or to drive a truck transporting medicine) and when the lock down started, all of Europe’s borders suddenly closed. We spent an entire weekend working just to get trucks across borders at one point. Now India is in lock down which makes it difficult for people to go to work there – India is a large manufacturer of medicines and active ingredients for medicines.  In addition, many countries, including countries inside Europe, have introduced a variety of restrictions on the movement of medicines. It is normal for governments to want to plan for a potential Covid-19 outbreak but beggar-thy-neighbour medicines hoarding is extremely dangerous at this time.

What should the EU and governments be doing to helping the medicines sector right now?

There are massive surges in demand in different countries right now and it is difficult to assess what is a real patient need and what is stockpiling/hoarding. The best strategy for everyone is to focus on three things:

        1. Support the industry to increase production output as much as possible (while respecting critical things like production quality – but everything else should be secondary).
        2. Apply a basic principle that medicines should flow to patients and not to large stockpiles that no one will use. This implies that hospitals with a high number of Covid19 patients should receive medicines as a priority and hospitals with few patients should be de-prioritised. This is not a fixed game – medicines will need to follow the patients. But stockpiling where this is unnecessary directly harms the places where medicines are needed. It’s deadly – literally. I’m simplifying this a bit and to be fair to countries, I understand some of the measures they are putting into place to limit unscrupulous speculation (I cannot say more…) to protect their patients. The problem is that my industry sometimes get caught in this – truly by accident – and it takes a lot of time to clear things up and to move the medicines to where they need to go. Looking forward, the EU will need to tackle this concern that countries have around speculation – it can be solved. Then we won’t have to deal with this if we face a crisis like this in the future.
        3. Improve the collection and sharing of information regarding the number of patients, the medicines required and the estimates that hospitals, regions, governments are making for this. Even basic information like how many months’ stock are you asking for? How many patients do you anticipate? is not flowing to the right places. This needs to be coordinated at country level and shared with industry and with the EMA/Commission to aggregate the demand. We are operating in a sea of fog right now and that is really not good. Some countries are not sharing this because they want to hoard local supplies (at the expense of their European neighbours) – this is pure insanity and is totally counterproductive as industry figures this out quite quickly. It creates way too much inefficiency in the supply chain.

What will you do differently in your life after the virus?

I’ll stop working from my living room couch and will probably buy a new couch. I’ll have to make it up to my wife who has taken care of my kids while I work all day and night (that will be a big pay back – any recommendations?).

Work wise, it is clear that this experience will lead to changes in EU pharmaceutical policy. A lot of the issues we have been raising for the past few years – like essential/critical hospital medicine market policies in Europe are dysfunctional and are disincentivising investment is manufacturing capacity will, I hope, be on the agenda. On the positive side, after some tense discussions with the Commission at the beginning, we have found a way to work together and to advance pragmatic solutions to improve the supply of medicines for patients. Industry and the Commission operate in very different way – completely different ways – but if both sides make an effort to understand and put forward solutions instead of complaining, it somehow works (not really sure how, but it does). With a little bit of effort and good will from both sides, the messy EU can actually deliver a lot of positive change. If that spirit continues post-Covid, and everyone is forced to put healthcare interests at the top of the agenda, we might build a better pharmaceutical policy. The triumph of hope over experience, you might retorque.

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