It's out - so what?

A big event – such as the publication of a Strategy on how to update and modernise the basic legislation of an entire sector – can create anticipation and excitement. The day after there is the danger of falling into post-event blues. With the Pharmaceutical Strategy from the European Commission, this is definitely not the case.

As largely anticipated, the big themes of the Pharmaceutical Strategy focus on accessibility and affordability of medicines; boosting the competitiveness and innovative potential of the EU pharmaceutical industry; enhancing the EU’s crisis preparedness and ensuring a stronger EU voice on the global stage.

First impressions

After a year for preparatory work in 2021, 2022 is set to be a big year for pharmaceutical policy circles in the EU. That is when the Commission’s proposal – or proposals – to revise the basic EU pharmaceutical legislation will be published. According to Commission Vice-President for Promoting our European Way of Life, Margaritis Schinas, this will be a ‘complete overhaul’ of the legislative framework to make it ‘future-proof and innovation friendly’.

As can be expected from a sector in which there has been little to no major legislative change at the EU level for years, the Commission has set an ambitious schedule for itself (and the rest of the EU policy actors). The actions proposed in the strategy are also aligned with other priorities of the Commission such as better regulation, cutting down on silos, the Industrial Strategy, the Green Deal and the Digital Strategy.

The Commission is looking into the revision of the regulations on medicines for children and rare diseases (inception impact assessment out the same day as the Strategy), reviewing the incentives and intellectual property system for pharmaceuticals, setting up a new authority for health emergency response, strengthening security of supply in the EU, launching a group to steer cooperation between national authorities on pricing, payment and procurement policies, and the creation of a European Health Data Space.

The Commission’s focus on cancer comes through clearly in the Strategy. Of course, this was to be expected. Europe’s Beating Cancer Plan is the first clear initiative from this Commission and the largest political group in the European Parliament – the European People’s Party (EPP) – has been championing the fight against cancer since 2018. Let us not forget, Health Commissioner Stella Kyriakides, Vice-President Margaritis Schinas and President Ursula von der Leyen all hail from the EPP.

What’s the big deal?

“We can now say with confidence that we have a set of actions that will allow us to defend that the EU needs more cooperation, more coordination and definitely more EU overall in health.”

The Commission has been clear on its goal – as we can see from Vice-President Schinas’ comment above. This is not just a question of tweaking a piece of legislation here or changing a delegated act there. The European Commission has a plan for overhauling the EU pharmaceutical legislation and it is ready to implement it. With COVID-19 and lessons learnt, it also has broad support for increasing collaboration and cooperation throughout the sector from joint procurement to pricing and reimbursement in Europe.

It will be necessary for stakeholders to ensure that this process – the biggest shake-up of EU legislation in many years – will create positive, long-term change. The Commission’s priorities are inspirational on the face it, but there is the danger of “not letting a good crisis go to waste” mentality taking hold in the EU institutions. Health is now a big policy topic. The Commission needs to avoid being swept along by the current public support and find real solutions to challenging issues in the sector.

When working to ensure access to affordable medicines to patients, will the EU institutions focus on prices – a message that seems to be coming through from the Commission?  Or will they adopt a more nuanced approach, taking into account the complexities of developing treatments and the diversity of companies investing in research and development?

Now is not the time to be complacent. Now is the time to act and shape the future.

Hanover’s IPMA team is a leading international policy and market access team in Brussels. We work with businesses and trade associations to bridge the gap between their business objectives and the policy environment they operate in.