The new disclosure rules on payments to doctors have come into force but there are likely to be teething problems as the industry begins to implement the new requirements, an industry expert says.
David Morrow, head of medical excellence in the UK and Ireland at AstraZeneca, told PharmaTimes Magazine there were practical dilemmas to address in both large and smaller markets.
“We’re on the start of a journey here. This is an industry-led initiative, and while it has been signposted for some time, the industry is still adapting to some of the complexities of the requirements,” says Morrow, who is a keynote speaker at the CompliMed Healthcare Compliance Conference on 27 April in London.
The UK is one of 33 European countries that will introduce and comply with the disclosure regulation, which came into force on 1 January this year, and was driven through by the European trade body EFPIA. Under the Disclosure Code, EFPIA’s member states are each required to write the rules into their respective codes of practice, which will require companies to disclose the names of healthcare professionals and healthcare organisations that have received payments, how much and for what activity, and to publish this information on a public platform. All payments made in 2015 will be published in 2016.
Some of the issues the industry has to tackle include data privacy, gaining and recording HCPs’ consent, adapting financial systems to both pay and record payments made by the home market as well as overseas affiliates, and ensuring effective communications with internal and external stakeholders, Morrow says.
“Moreover, for this to be effective we also need complete buy-in from HCPs, which may take more than the first year,” he insists. “We know from market research that HCPs are broadly in support of this initiative but despite industry communications, they may still have reservations about the implications of disclosure. For instance, in 2016, when the first payments are published, it will be interesting to see how the press interprets and reports the disclosures.”
Morrow believes it is too early to tell what impact the disclosure rules will have on the relationship between HCPs and the industry but he is optimistic about the relationship in the future. “This is one of the biggest changes for the industry in the past 10 years, and it’s unique – something the industry has put in place, not something that has been imposed on it. It‘s an example of the industry using its own initiative to improve its reputation. By driving transparency we endeavour to ensure there is ongoing public trust and confidence in the relationship between the industry and HCPs. It’s a real opportunity for pharma to make a difference to how it’s perceived and to shine a light on the invaluable and highly necessary collaboration between industry, HCPs and the NHS, particularly in the fields of R&D and medical education.”
David Morrow will be speaking at the CompliMed Healthcare Compliance Conference on 27 April, in London, and will share his insights on practical solutions to implementation concerns surrounding the Disclosure Code. He will be presenting alongside Victoria Saunders from the ABPI and Omar Ali, formulary development pharmacist, Surrey and Sussex NHS Trust. For more information go to www.complimedltd.co.uk/2015conference
SPONSORED COMMENT: Transparency and disclosure top compliance challenge
Adhering to transparency and disclosure requirements is the single biggest compliance challenge for UK pharma today. As David Morrow from AstraZeneca mentions, the future holds the promise of pharma driving transparency and improving relationships. It’s therefore essential that any potential teething problems are ironed out.
The CompliMed Healthcare Compliance Conference (27 April, London) delivers expert insight to support those working with the Code. Although operational aspects of the disclosure requirements are a focus, other debated areas, such as digital communications and the evolving MSL role, are also on the agenda.
For more information, visit www.complimedltd.co.uk/2015conference