Despite an exceptional unity of intent during the pandemic, the revision of the bloc’s pharmaceutical legislation could suffer a bump between the EU’s vision for health and this is still conceived at the national level, Lars Fruergaard Jørgensen told EURACTIV.
Lars Fruergaard Jørgensen is CEO of Danish pharmaceutical company Novo Nordisk and the first vice-president of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
What could be the contribution of the pharmaceutical sector to the nascent European Health Data Space?
In Europe, we take personal data and privacy very seriously. When you look at the pharmaceutical companies, we have a lot of experience in conducting clinical trials, sometimes with hundreds or thousands of patients. Even large outcome trials are all made anonymous so we can still extract learnings and submit them to regulators.
If we could have at the European level one system to pool all the clinical data, it would be a tremendous resource of insights. And if you can start following patients over time, you can also better assess the value of a medicine.
Tech companies as well are involved in the development of the EHDS. Could it be a problem?
Tech companies are different because you have wearables and they are linked to the individual person. It’s essential to understand how data is used, as well as regulatory aspects in terms of having validated data and robust data capture.
But can these two worlds – pharmaceuticals and tech – come together?
Yes, if you have a sensor on you collecting, for instance, your glucose level with this info going into a cloud and being anonymous. But there needs to be a regulated validity around those data if you are to really build evidence that can be used in how we decide to use products and define prices. There’s a lot of value in some personal health wearables but I’m not sure how that should be consolidated.
The revision of the pharmaceutical legislation is much-awaited. What are the thorny issues with that dossier?
They will probably be some difficult discussions between what is the vision for health at the European level compared to how health is conceived at a national level. There are certain things that have been inspired by the unity that was created during the pandemic. However, all healthcare systems are national today and the decision power sits in the countries. I don’t think countries want to give up that.
Rare diseases and orphan drugs will be a topic of discussion in this reform.
There are diseases where there is no medicine today because there is no market. So, unless there are some incentives, there will never be medicines for those people. You can say it’s a societal choice. Do we want to help those individuals? If we want that, society needs to give some incentives.
But it’s a difficult topic because there are also politicians who feel that incentives are too rich, that pricing is too high, and it’s basically much too attractive for the industry. It’s important to get into talking about the facts. How many patients are there? What’s the price point? What’s the journey to getting medicines to patients? As part of making this uniform technology assessment, the pharmaceutical sector can actually assess what is the value of treating a patient.
Little is being said in the EU health bubble about the implications of trade talks with India which is, however, a major producer of generics. What’s your take on that?
Health systems in Europe depend on India to a degree that they are not aware of. During the pandemic, we had critical, important life-saving generics used in intensive care units, something medical doctors normally just take down from the shelf and then, suddenly, they were no longer there because supply chains were no longer working.
I’m not sure pharmaceuticals are part of the trade talks but we need to create a bit more informed way of buying medicines. Most people will be surprised that life-saving medicines in the intensive care unit are also procured based on the same principle, namely their price.
Another recent debate in the health world with a ‘global’ flavour was the one on the intellectual property waiver on COVID-19 vaccines. What did you make of the whole controversy?
It’s interesting to reflect that the industry brought five different vaccines in record time, all of those based on a certain degree of innovation and the 2 mRNA based on an innovation going on for only 20 years. And we were really lucky that they were there. Next time around, we have to be lucky again that somebody else has invested in some science that is ready to be used. We also scaled up manufacturing in record time, so that billions of doses were basically available for the whole world. And some manufacturers even gave away the licence to produce abroad, like for instance in India.
Still, there is a political agenda in the Western world to feel maybe some sort of bad conscience and they are proposing to waver IP rights in future situations. I get a bit emotional because I think this is politics at its worst, as it’s not helping anyone. It’s actually destroying the incentive to make the next version of vaccine or cure we all need.