As an industry we continue to deliver innovative, life changing medicines and rewrite the story of many diseases, yet our social contract remains the subject of debate, commentary and challenge.
The conventional focus on prescriber relationships, though still important, has been increasingly superseded by the outcomes of health technology assessment (HTA) decision-making processes, guideline content and formulary inclusion. Fewer individuals are having a far greater impact on the use of a medicine.
It is in this context that our data, our actions and our relationships are the subject of unparalleled analysis and external scrutiny.
Transparency, particularly regarding financial relationships with the healthcare professionals (HCPs) that patients and the public know and trust, is no longer a ‘nice to have’, it is a societal expectation and part of our licence to operate. This is an area where the pharmaceutical industry must take the lead.
So what action is the pharmaceutical industry taking to make relationships with HCPs more transparent for the benefits of patients?
Actions speak louder than words
It is absolutely essential that patients have confidence that the relationship between their HCPs, who prescribe their medicine, and the industry that makes the medicines they rely on, are open and transparent. It is not just about transparency. We have a long established commitment to ensure that our relationships are appropriate.
There is already a clear framework for the pharmaceutical industry, which is administered at arm’s-length of the ABPI by the Prescription Medicines Code of Practice Authority (PMCPA). The ABPI Code of Practice for the Pharmaceutical Industry sets standards of ethical interactions in the UK between the industry and HCPs and has developed its guidance in this area over the years.
It is also important to note that doctors, pharmacists and pharmacy technicians, and nurses and midwives each have their own code of conduct, which each cover the areas such as making prescribing decisions on clinical grounds, conflicts of interest, transparency and gifts and hospitality, and this is also backed up by UK law (the Human Medicines Regulation 2012).
In the boundaries of these regulations, it is entirely appropriate that HCPs are fairly compensated for their time and expertise when providing services to the pharmaceutical industry, and we have made a transformational step in the work we have done to be more transparent about payments.
This is a journey that began back in 2010, when members of the ABPI voted to introduce disclosure of aggregate totals paid to health professionals and the number of HCPs they work with. In April, we disclosed aggregate payments to HCPs in the region of £38.5m for payments made in 2013.
This was a first step towards increasing transparency about the relationships we have with HCPs and has helped pave the way for the next step when, from 2016, pharmaceutical companies will publish details of certain payments made to individual HCPs in 2015 for the first time in the UK.
As far as healthcare organisations (HCOs) are concerned, benefits in kind, fees for services, contributions towards events and joint working will have to be disclosed, in addition to the current requirements to disclose grants and donations. The aggregate spend on certain research and development (R&D) will also be disclosed.
These commitments are incorporated in the ABPI Code of Practice 2014 and are in line with the European Federation of Pharmaceutical Industries and Association’s (EFPIA) Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations Disclosure Code (2013), which sets out requirements for public disclosure of certain payments to HCPs in 2016 for 33 countries covered by the EFPIA Codes.
We should be proud of the relationship between the pharmaceutical industry and HCPs in the UK. It is a relationship that has helped develop many lifesaving medicines and has long been a positive driver for advancements in patient care and the progression of research. In fact, one eighth of world’s most popular prescription medicines were developed in the UK as a result of collaboration with HCPs.
There are benefits for HCPs, industry and, most importantly, patients. HCPs need to stay informed about current and new medicines to provide patients with the best possible care, including treatment options, and the pharmaceutical industry has a duty to provide HCPs with the latest information on its medicines to help ensure that they are able to make the best treatment recommendations to their patients.
Views from the HCP community
There is a strong shared determination among leading HCP organisations, patient groups and commercial organisations to ensure that relationships are based on transparency.
In 2013, a consultation was conducted to identify in principle whether there would be support from the HCP community for a centrally-hosted, single, searchable database, with a proactive role for HCPs in validating and submitting financial information.
The overwhelming majority of respondents, including representatives of the leading HCP bodies and over 1,000 individual HCPs, agreed that payments should be transparent and publicly declared (90%), and that HCPs should have a role to play in making this happen (77 per cent).
83% of respondents supported disclosure on a single, searchable database and 88% felt that public disclosure of payments should include payments from commercial organisations from other sectors such as medical devices and diagnostics.
In April this year we brought together senior stakeholders from across the medical community to discuss plans for disclosure of payments to HCPs, and to look at how we can co-ordinate efforts to develop disclosure in a way that meets the expectations and needs of HCPs and industry.
The meeting has resulted in a number of follow-up conference sessions and publications from participating organisations to inform and update HCPs on plans for disclosure. There is good awareness of public disclosure of payments happening in 2016 in medical leadership and across professional bodies and medical royal colleges, and we are continuously striving to enhance the levels of awareness among HCPs.
Building awareness and understanding of the disclosure project in the HCP community is of paramount importance, and the first wave of communications materials to support that process will be launched soon.
Transparency beyond borders
The drive to increase transparency of relationships with HCPs and HCOs is a Europe-wide initiative. EFPIA agreed the EFPIA Disclosure Code in June 2013. The EFPIA Disclosure Code includes requirements for public disclosure of certain payments to individual HCPs and HCOs from 2016 for payments made in 2015.
The central platform to disclose being considered by the ABPI, together with the proposed changes to the 2014 ABPI Code, finalise the implementation of the EFPIA Disclosure Code in the UK. Several other EFPIA member associations have declared an intention to disclose payments via a central platform or portal.
In the US, The Physician Payments Sunshine Act, or ‘Sunshine Act’, was passed as part of the Patient Protection and Affordable Care Act (healthcare reform) in 2010. The law is designed to bring transparency to financial relationships between clinicians, teaching hospitals and the pharmaceutical industry.
The Sunshine Act requires manufacturers of pharmaceutical drugs and devices, as well as group purchasing organisations (GPOs), to report payments or transfers of value (such as meals, honoraria or travel reimbursements) made to US doctors and teaching hospitals.
The law also requires manufacturers and GPOs to report doctors who have an ownership interest in the company.
Such legislative requirements are not confined to the US. A number of European countries have varying requirements either under legislation, regulatory body requirements or through a multi-stakeholder agreement.
How will UK payment disclosure work?
Whilst proposals to build on the EFPIA requirements and create a single, searchable database in the UK are still out to consultation and its potential functionality still under development, we are excited about the prospect of what it will achieve. The aim is to ensure that the data that companies have invested time and resource collecting is presented in a way that is transparent, accessible and meaningful for stakeholders.
Accessed through the ABPI website, users will be able to search the database by a variety of fields such as first name, last name, HCO, place of work, city of principal practice or company. In developing the system we have prioritised accessibility, company workload and consistency with the pan-European approach.
Companies will upload data to the system in a standard template using a secure login.
Data from the templates will be matched, consolidated and a unique ID assigned to each record to facilitate accurate search capability. In addition to individual payment data, the disclosure pages of the ABPI website will also publish payments to HCOs, aggregate totals of company R&D spend and a total figure for R&D in the UK.
The UK template, currently part of the PMCPA public consultation, is as close to the EFPIA produced template as possible whilst recognising the additional reporting requirements under the UK Code such as joint working and changes needed to facilitate the development of a central platform.
The finalised template and changes to the Code mandating use of the central platform will be published if agreed in November.
The disclosure of payments to HCPs is about bringing further transparency to the relationship between industry and the people it works with. It is a relationship that is critical to the future of medical innovation and patient care and as such, should meet the high expectations of patients and wider stakeholders.
As an industry, our responsibility to patients and to society extends beyond the sale and purchase of new medicines. It is about playing our part in meeting the challenges faced by healthcare systems the world over. Taking on that role means working collaboratively with HCPs, so the addition of disclosure requirements on top of existing frameworks should allow us to move forward in confidence.
By Andrew Powrie-Smith, ABPI director (Pharmafile online)