Is Patient Engagement Brexit-Ready?

Whatever the final outcome of Brexit, investing in supporting advocacy communities will be an important element of maintaining trusted relationships with patient groups and stakeholders in the UK and the EU, write Nick Hicks and Tamsin Rose.

Nick Hicks

Advocacy, whether it is with patient groups, nursing associations or medical societies, is by nature dynamic and constantly evolving. The founding imperative is building respectful, honest and trusting partnerships. The construction of these relationships does not happen overnight; it takes time for the different players to get to know each other. Without question, Brexit and the accompanying disappearance of the UK-based groups from the EU will change the pattern, type, and composition of the already complex European advocacy landscape.

In what ways the change will happen is still unknown, but two things are clear:

(i) with the EMA’s move to Amsterdam, the UK is losing its traditional position as the center for patient engagement;

(ii) Brexit offers life science companies a critical and unique opportunity to support its patient and wider advocacy communities manage the transition process.

Tamsin Rose

Patient and professional advocacy groups are an important part of the process by which the marketplace is educated on new medicines. Strong relationships with advocacy groups have been shown to be vital for disease awareness campaigns educating the public on socially-sensitive conditions and discussing treatment options with regulators. The UK has one of the longest traditions of patient advocacy within Europe; UK patient groups are some of the most advanced and strongest in terms of their research skills and capacity.

However, with Brexit there is a real danger that the UK will no longer be relevant, for example, when companies are looking to do European studies to support a submission.¹ This is already happening. UK patients have already been cut from an international cardiology trial because of uncertainties about registering new medicines after Brexit.² UK patient groups may find themselves excluded from meetings or working groups which they previously headed or not be asked to lead delegations simply because the working language is English.

The intriguing question of English being used as the common language in an institution which the UK is no longer part of is likely to keep on surfacing. Obstacles may also arise with UK-registered European patient or other advocacy groups and there may be some internal push back to pursue changing their statutes to a country still in the EU. In case of a lack of European associations for a specific disease or treatment area,  EMA states that involvement of national organizations may be considered, although preference will be given to European wide associations.³ This is likely to pose some challenges for UK only rare disease or newly formed groups for example.

While potential gaps may be filled by remaining EU27 representatives, these groups will need to be brought up to speed before new relationships and partnerships are forged. It would be useful, at least in the early stages, to map points of conflict and common interest with new players before amending any advocacy strategy.

The topic is simply too complex and fast-changing for a desk-based mapping exercise, so companies will need to manage this risk in real time. As a relationship building tactic, we recommend inviting external advocacy group leaders and members of the medical advisory board to discuss the implications of the new landscape. This will allow the group(s) to articulate any new priorities, issues or concerns.

One of the biggest challenges likely to come up may be continued access to funding as many groups rely heavily on EU grants. Such initiatives will help guide the company’s understanding of future patient needs, requirements and perspective. While rare disease groups are more likely to be aware of Brexit implications this may not be the case with some of the other groups and are likely to find such an initiative very helpful in guiding their future direction.

The new number one?

The question of which EU country will become the new center of gravity for patient engagement, or at least share the number-one spot, also arises. One candidate, France, stands out for various reasons. First, the country has a highly centralized health care system and its well-respected medicines regulator, the Haute Autorité de Santé (HAS) has contributed to a strong compliance culture. It has also recently created a dedicated pathway for direct patient input into the HTA system. France also has a long tradition of NGOs and the vibrant association sector is governed by the 1901 law on nonprofits. The French advocacy community has recently undergone a culture change and English is now widely spoken among campaigners used to working in global coalitions.

There is a strong life sciences sector in France, traditionally centered in Paris and the powerhouse cluster of research and vaccine development in the Lyon region. At government level, President Macron has spoken about the need to reduce the regulatory burden for pharmaceutical companies⁴ and has committed to major investments in IT and AI to revolutionize healthcare. These positive developments need to be balanced with the more traditional, hierarchical role of the doctor and the wider medical community in France.

At the time of writing, the prospect of a no-deal scenario for Britain's exit from the EU is becoming a strong possibility. Whatever the final outcome-whether it is UK Prime Minister’s Theresa May's plan, a no deal, or no Brexit-investing in supporting advocacy communities through the transition will be an important element of maintaining trusted relationships with patient groups and stakeholders in the UK and the EU.

Nick Hicks, is an advocacy and patient engagement consultant for the life science industries. Tamsin Rose is a Brussels-based European Health Policy consultant. 
 

References

1.     https://www.pharmaceutical-technology.com/features/brexit-and-the-pharmaceutical-industry-no-deal/
2.     https://www.independent.co.uk/news/health/brexit-heart-attack-drug-trial-research-european-medicines-agency-recardio-dutogliptin-a8566426.html
3.    https://www.ema.europa.eu/en/partners-networks/patients-consumers/eligible-patients-consumers-organisations
4.     https://pharmaphorum.com/views-and-analysis/macron-healthcare-france-europe/