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A new EU in the making, what lies ahead for pharma?

Big decisions on Europe's leaders and strategy await

eu

In conversation with Antoine Mialhe, head of healthcare Brussels,  strategic communications, FTI Consulting

After May’s European Parliamentary elections, the EU’s member states have to thrash out the all-important decisions about who will lead the European Commission.

These negotiations always take time, and a summit of 28 European Union leaders last week failed to reach agreement on the key issues.

The first question is who should take on the bloc's top jobs, most especially the president of the European Commission role, currently held by Jean Claude Juncker.

On the shortlist of candidates are Manfred Weber, a German from the centre-right European People's Party (EPP) and potential rivals such as Frans Timmermans (Dutch, from the centre-left Socialist bloc) and Danish EU commissioner Margrethe Vestager, a liberal.

Opinions remain divided, however, with different member states supporting their own favoured candidates. French President Emmanuel Macron is said to be backing the candidacy of Michel Barnier – who of course is currently in charge of the Brexit negotiations with the UK.

Europe’s leaders will also have to reach agreement on what big strategic issues the EU should prioritise over the next five years.

The next summit will be held this Sunday, 30 June, just two days ahead of a key meeting of the European Parliament.

Ahead of the elections, European pharma’s representative body EPFIA launched its own manifesto, hoping to influence policy over the coming years.

Antoine Mialhe

Antoine Mialhe

We ask EU politics expert Antoine Mialhe for his views on what lies ahead for the EU, health and pharma over the next five years.

EFPIA has set out its own manifesto, and it is obviously looking for some pro-business policies to help life sciences in Europe. What are they key ones as you see it, and what will determine their success over the next 5 years?

The pharma industry has been very defensive in the last 5 years and fought very hard against low impact changes to the SPC legislation. This was probably a battle to give away to preserve an already damaged reputation. And avoid the bigger threat which is on a number of EU officials’ mind: a whole revamp of the pharma framework.

Newly elected MEPs are likely to keep pushing back the industry’s agenda. The Greens won a great number of seats and will play on this result to secure high profile jobs at the ENVI committee which is in charge of Environment, Public Health and Food Safety policies. And the Greens are not really the greatest supporters of the pharma industry…

MWMWFT Michel Barnier

Candidates for the President of the European Commission role: Manfred Weber, Margrethe Vestager, Frans Timmermans and Michel Barnier

Margrethe Vestager was being tipped as a possible EC President. She has taken a very tough line on competition and IP, which are obviously big issues for pharma, and has taken tech giants like Google to task. 

Vestager was best placed to get the job...until last week’s summit during which the three top names (Weber, Vestager and Timmermans) were discarded.

But let’s see if Vestager does not come back through the back door. Although she made waves with the rejection of the Alstom Siemens mega merger, she is better placed than other candidates. She has been creative in the way she pushed the boundaries of the treaties with, for example, the pricing investigation over Aspen Pharma. She also sent a very clear signal to pharma companies: the absence of pharma drug pricing competence will not prevent the EU from intervening.

There is also an interesting study that will be released soon, which looks at the impact of M&A on innovation that is being prepared by DG Competition, which she currently runs. This study is likely to set the Commission’s thinking on that critical topic for the sector.

Do you think she will be seen as anti-business in the pharma sector? Is there a candidate they would prefer e.g. Manfred Weber?

I don’t think she is being seen as anti-business. She for example showed great alignment with the German economy minister Peter Altmaier, who is pushing for a new EU industrial strategy. But as she said, ‘no ecosystem can thrive if it depends on just a few big species’. Now, there is great uncertainty around her getting the top job.

Bearing in mind the results of the European Parliament elections and the need for a greater coalition with the right, left, centrists and greens, it seems very unlikely that the next European Commission President would have a strong anti-pharma/industry stance.

One of the big issues is the proposed legislation on harmonising/simplifying HTA across the EU. Do you see those laws being passed quickly, and to pharma’s satisfaction?

The HTA file is in a difficult situation at the moment with Germany and France blocking it. It’s a pity because the current system – purely national - is not sustainable and does not work for most Eastern countries. Although not ideal, there is not so much at stake for big pharma, which can live with duplication and fragmentation. Also, siloed approaches somewhat safeguard their bargaining power with national healthcare systems.

For smaller companies however, the stakes are higher. If France, Germany and a few other countries want to support innovation and faster market uptake up to the finish line, they should reconsider their positions.

EU biotech have taken to the habit of launching first in the US. – and although HTA is not going to fix the issue alone – it is one piece of the puzzle that really needs to be addressed.

Antoine Mialhe is head of healthcare Brussels, strategic communications, FTI Consulting.

Article by
Antoine Mialhe

27th June 2019

Article by
Antoine Mialhe

27th June 2019

From: Healthcare

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