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On April this year, British pharmaceutical companies disclosed for the first time an aggregate figure of their financial relationships with HCPs and HCOs (see article about ABPI disclosure). This move is only the first in a global trend for transparency with the recent publication of the final draft for the Sunshine Act in the US and the EFPIA Disclosure Code in Europe.

The EFPIA Code on the Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations will receive its formal approval at the next general assembly on 24-25 June; it is required to be transposed into national Codes by 31 December 2013.

Several countries in Europe have already undertaken actions to increase transparency between pharmaceutical companies and HCPs (France, Slovakia, UK, Portugal), by acting now and adopting a proactive approach, the EFPIA has the opportunity to help encourage a consistent approach to data disclosure in Europe and help guide further action at national level.

Richard Bergstorm (director of the EFPIA) has recently outlined the need for two types of transparency, data transparency and transparency in relationships. Data transparency does not yet have a clear outreach and guidelines but this amended code will impact the second view on transparency.  Other disclosure activities outside of Europe have already been undertaken (Japan,  US) but Mr. Bergstorm stressed the fact that the EFPIA wants a more pragmatic approach on transparency and take time to discuss with the different stakeholders in order to gain a widely accepted system of disclosure. This is why this timeline has been approved with a first disclosure to be made in 2016 for payments of 2015, to help encourage a consistent approach to data disclosure in Europe and help guide further action at national level.

There are 3 levels of disclosure established: Aggregate, Individual HCO and Individual HCP:

•At an aggregate level: everything concerning clinical trials (phase 1 to 4) for donations and grants, sponsorships, events & hospitality and fees for services & consultancy.

•For individual HCO: Donations & Grants, Sponsorships, events & hospitality: registration fees; travel & accommodation; and associated ToV (Threshold of Visibility. Such as food, beverage & others exceeding threshold), Fees for service & consultancy

•For individual HCP: Same as HCO except fees for service and consultancy

One of the major concerns for European pharmaceutical companies is the publication of individual names regarding the Privacy laws and regulations in national legislations and EU directives. The article 29 WP of the EU Data Protection Directive underlines the fact that for disclosure of individual names where ToV to a HCP occur in the context of a contract, the contract provides a ready mechanism to obtain the data subject’s consent to the processing of his/her personal data for the purpose of meeting that member’s obligations under the Code. As matter of good practice, data controllers should create and retain evidence showing that the consent was indeed given.

Member Associations will be required to transpose the EFPIA Code into national codes.

Each association will take the necessary legal opinions – in principle, these should not be different, although there may be a matter of judgement. In some countries, self-regulation needs to be submitted for approval by national competition authorities

The Codes Committee will collect comments on national legal advice that may raise issues with transposition of the EFPIA Disclosure Code in May 2013.

In the UK, there will be many changes to the ABPI Code to implement the EFPIA Disclosure Code. Much of the information needing to be disclosed was already at an aggregate level in 2013. Proposals to amend the ABPI Code will be drawn this year and submitted for approval at the next general assembly at the end of the year.

 

Support and further reading:

·         www.efpia.eu

·         http://ec.europa.eu/justice/data-protection/article-29/

·         www.pmcpa.org.uk/

 

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