Which Transfers of Value (ToVs) made to Healthcare Recipients need to be disclosed?

It's a deceptively simple question - and one I'm often asked by scaling pharmaceutical companies entering into or expanding across Europe.

The challenge is that many organisations underestimate their Transfer of Value disclosure obligations under the EFPIA Code. A 'risk-based' approach may seem tempting, but it can create compliance risks, reputational exposure, and result in unnecessary costs further down the line.

In this article, I set out a practical example and explanation of which ToVs need to be disclosed, and why. I also look at practical steps to manage compliance in a way that is scalable, efficient, and realistic for growing pharmaceutical companies.

A simple scenario:

Size:

• A scaling pharmaceutical company has secured its first product authorisation in Indication No.1.

Authorisations & Pipeline:

• Marketing Authorisation has been granted in the EU (via the centralised procedure) and the UK.
• There is an active pipeline with eligibility requests to be submitted to the EMA shortly for two further products and active clinical trials, both in set-up and ongoing.

Pricing & Reimbursement:

• Pricing & reimbursement have been agreed for the first licensed product, and the company has active sales in Italy, Austria and the United Kingdom. 
• Negotiations for pricing & reimbursement are ongoing in France, Poland, Spain and Switzerland, with the rest of Europe to follow in stages.

Entities within the Group are engaging and making ToVs to *Recipients across **Europe, including: 

1)   Contracting Healthcare Organisations and Healthcare Professionals to provide consultancy services (including Healthcare Professionals directly and via their Healthcare Organisations where required) - ranging from advisory boards to consultancy with respect to patient pathways and best clinical practice in Indication No.1;

2)   Holding and sponsoring Events, as well as supporting HCP attendance at Events; 

3)   Making Educational and Research Grants to relevant Patient Organisations; and

4)   Sponsoring global clinical development programmes.

OPTION 1:   ToVs made by Group entities to Recipients in Europe where those Group entities are members of National Member Associations;

OPTION 2:  ToVs made to Recipients in countries where the Group has an entity that is a member of that country's National Member Association; or

OPTION 3:  All ToVs made by all entities within the Group to all Recipients in Europe.

EFPIA membership is composed of:

1.  Associate Members; 

2.  Members of Specialist Groups in EFPIA; and

3.  Full Members.

Full Members consist of Member Companies and Member 

Associations. 

EFPIA defines Member Associations as: 

Managing compliance doesn't need to overwhelm your teams. 

I work with scaling pharmaceutical companies to design lean, practical compliance frameworks that work with their resources and growth stage. 

If your organisation is navigating compliant healthcare professional engagement and EFPIA disclosure obligations, I'd be glad to explore solutions that work in practice and are cost-effective.

* EFPIA Code defines Recipients as: "any Healthcare Professional (HCO), Healthcare Organisation (HCO) or Patient Organisation (PO), in each case, whose primary practice, principal professional address or place of incorporation is in Europe."

** EFPIA Code defines Europe is defined as "those countries in which the EFPIA Member Associations' National Codes apply":  Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, the Netherlands, North Macedonia, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and the United Kingdom (as at June 2019).