Preparing Europe for the next pandemic, the place of One Health in the European Health Uninon, and, a step further, the role of the EU in R&D

 

Apparently work for setting up the European Health Union is going forward full steam ahead since my last article on the topic, dating May 2021 (take a look at it to have more details, as well as links to the policy documents). The European Commission (EC) welcomed an agreement on a stronger European Centre for Disease Prevention and Control (ECDC) and European Medicines Agency (EMA), and is supporting the brand new Health Emergency preparedness and Response Authority (HERA) in her first initiatives.

The EU wants to be covered for the next health crisis, by strengthening not just the early detection, but also when it comes to supply of medicines, vaccines, and other medical material, with EMA monitoring the possible shortages.

A rather ambitious plan that should – and will, I am sure – protect all those living in the EU. Let us just think how better prepared could the EU have been in the early days of the pandemic. National responses were fragmentary and often poorly coordinated at the EU level. We were testimony of panicking leaders taking often chauvinist national(istic) measures, resulting in little benefit for public health. If only we – as a Union – had a better plan! This is the gap that the European Health Union fills.

There are two aspects I would like to point out.

We know that most of (re)emerging threats are of zoonotic origin, so it is just natural for the One Health approach to have a central place in the European Health Union policies.

Commissioner Kyriakides, opening the November 2021 European Public Health Conference, underlined the “vital importance of the One Health approach” in order to improve the prevention, surveillance, and response to cross-border threats. In particular she was referring to the proposal for a new regulation on cross-border health threats (a legislative pillar of the European Health Union package).  “Working together – truly, across all sectors and professions - offers us the best -- indeed the only chance at securing a healthier future for us, for the next generation”, she added.

 “Working together – truly, across all sectors and professions - offers us the best -- indeed the only chance at securing a healthier future for us, for the next generation”

said Stella Kyriakides

Unfortunately said proposal hardly mentions the One Health approach, or any other multisectoral or multidisciplinary modus operandi.

At the various workshops and meetings on the European Health Union there is always a lot of stimulating discussion around its budget, how to avoid duplication of efforts between European organisation and with international agencies etc. The crucial importance of multisectoral cooperation is often raised and acknowledged. It is clear for everybody that to be prepared for the next pandemic we have to look with particular attention at the human-animal-environment interface.

The impression is, however, that the policy lags behind, and what appears to be clear in theory, is seldom highlighted in official papers.

credit:ec.europa.eu

 

The second aspects that I would like to reflect on is a bit further away from the classical One Health topics: what about the R&D and production?

The European Health Union will complement the revised Pharmaceutical Strategy, EMA is going to accelerate the approval procedure of new medicines (importantly vaccines), and HERA is going to collaborate with the industry when it comes to production of certain medicines (to me is still not clear how though. Will it have the power to shift industry’s priorities?).

Now I hate to be political, however sometimes technical solutions alone fail to address the bigger picture

Since the beginning of the COVID-19 crisis, weakness of R&D, production and distribution chains have become evident, especially in the early moments of vaccine rollout. The (rather embarrassing) condition of having to rely entirely on the private sector could not be avoided.

On the one side this situation meant unprecedented pressure on drug producing companies, on the other hand those same industries suddenly had a ridiculous amount of political power.

Apparently this issues was noted by European bodies, not exactly in the terms I put it though, and the EU Parliament asked itself “Could public infrastructure overcome market failures?”. The Panel for the Future of Science and Technology requested a very interesting study on the policy options available, and ended up with four alternatives:


1.       To create a European Medicines Infrastructure for pharmaceutical R&D. Its priorities will be chosen in the public interest, but focused on infectious diseases.

2.       Like option 1, but not just focused on infectious diseases and working also with external partners.

3.       To set up a large European Medicine Infrastructure fully focusing on infectious diseases, going from basic research to the delivery of new medicines “with appropriate contractual arrangements with third parties”

4.       A large-scale R&D Infrastructure, similar to option 2, but even bigger, running projects mostly in house and focusing on the delivery of medicines. It will represent “the most important public R&D infrastructure in the world […] It would firmly place Europe as the top global player in the field of R&D for medicines”

Which one of the above options benefits the most EU citizens and residents? Or, to put it in other terms, is the Pope Catholic?

"Although [...]  the setup  of  HERA  and  the  reinforced  role  of  EMA  and  ECDC  constitutes progress compared  to  the  pre-COVID-19  situation,  such  a  scenario  is  not  designed to address the market and policy failures affecting the pharmaceutical R&D system."

Taken from: European pharmaceutical research and development. Could public infrastructure overcome market failures?  2021. doi: 10.2861/72339