Charting our route towards HCP disclosure
This has given rise to the buzzword of our age, something that applies across all industries, but is extremely relevant in the pharmaceutical sector: transparency.
So what we need to do is to lay bare as much information about ourselves as we feasibly can, from the data we generate, to the company we keep. Europe is already heading in the right direction and the industry is not only playing its part, but in certain areas we are actually leading the way.
On July 24, 2013, EFPIA and PhRMA formally launched our Joint Principles for Responsible Clinical Trial Data Sharing to Benefit Patients. This commitment, which was implemented on 1 January 2014, continues to enhance research and scientific knowledge, advance patient care and improve public health. Under the Principles, biopharmaceutical companies are dramatically increasing the amount of information available to researchers, patients, and members of the public.
The EU has also thrown its weight behind increased transparency, with the adoption of the EU clinical trial regulation (536/2014) and the publication of the European Medicines Agency’s Transparency Policy (Policy 0070).
Transparency, though, goes beyond the world of trials.
Patient groups have given patients a stronger voice. They are involved in disease education; provide help lines and information, emotional support, and access to treatment. They are also crucially engaged in discussions about the healthcare system.
Recognising the increasing representation and input of patients in health via these organisations, EFPIA consequently adopted a Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations in 2007 – which was updated in 2011. The aim was simple: to ensure that relationships between the pharmaceutical industry and patient organisations continue to take place in an ethical and transparent manner.
In 2013, EFPIA embarked on a new phase of openness: tackling its member companies’ relationships with healthcare professionals and organisations. Collaboration between industry and healthcare professionals is essential and, ultimately, benefits patients. Industry and health professionals collaborate across a range of activities from clinical research, sharing best clinical practice and exchanging information on how new medicines fit in to the patient pathway.
In the US, the Physician Payments Sunshine Act, was designed to increase transparency relating to financial relationships between health care providers and pharmaceutical manufacturers.
The Sunshine Act requires manufacturers of drugs, medical devices and biologicals that participate in U.S. federal health care programmes to report certain payments and items of value given to physicians and teaching hospitals. Manufacturers now are required to submit annual data on payment and other transfers of value that they make to covered recipients.
In Europe industry is being proactive on the transparency of its relationships with health professionals and healthcare organisations. On 2 July 2013,EFPIA announced the release of its disclosure code of transfers of value to healthcare professionals and organisations. The code requires all members of EFPIA to disclose transfers of value to HCP’s and HCO’s as of 2016 regarding all transfers in 2015.
The EFPIA Disclosure code is a self-regulatory response to the societal expectations on transparency, although there are pockets of legislation on the issue in individual EU Member States, such as Slovakia, Denmark, Portugal, Romania, Greece and France. The Slovakian Transparency Act requires companies to submit by the end of January each year submit by January 31st a report to the Ministry of Health on value transfers to HCPs, excluding those related to R&D, or made to HCOs. The payments are recorded on the Ministry’s its website. The French Sunshine Act (Loi Bertrand) of 2013, covers value transfers to HCPs and HCOs. Disclosure obligations are also retroactive to 2012.
We will only really be able to measure the real impact of EFPIA’s HCP/HCO disclosure code in the years to come. Comprehensive transparency that promotes trust in our relationship is our promise to patients and our ultimate destination. As an industry we are committed to working with our health professionals and organisation colleagues to embrace this transparent future.
For more information on disclosure of payments to health professionals, you can visit: