Life Science Compliance Update

July 28, 2015

Undercover Report on Industry Relationship With NHS Inspires Discussion For UK Sunshine Law

  Under cover


Last week, Telegraph UK published a number of articles based on undercover interviews that targeted the relationships between drug companies and employees of the National Health Service (NHS). The articles noted that that NHS formulary decision-makers may also work as paid company consultants who can recruit other influential NHS employees to advisory board meetings. One interview in particular revealed that these meetings may be held in exotic locations at fancy hotels.  

In the United Kingdom, NHS hospital trusts and Clinical Commissioning Groups (CCGs) produce a formulary of medicines deemed preferable for prescribing within a given locality—there are currently 209 CCGs operating in England. Earlier this year, undercover reporters posed as promoters for a drug company, and asked influential NHS health officials how best to get CCGs to switch drug their company’s products.

The article highlighted one board meeting in particular where a pharmaceutical company paid the head of medicines management at the Isle of Wight CCG £5,000 to help organize an event. The company brought 12 payers together in Germany to one of the “top ten hotels in the world.” Speaking to the undercover reporters, the NHS employee noted that each delegate was paid £500 a day to attend and that all of those who were invited “switched” to the drug company’s product after the trip. “We have to be careful not to choose a nice venue just because it’s a nice venue. But it does it does sway people,” he added.

In another case, the formulary development pharmacist at one NHS trust, who has since resigned, advertised that he had a network of more than 100 health service officials who make decisions about what drugs to buy. “I’m talking about the payers who will make a decision on which drug they have on the formulary,” he said in the undercover video. He said he would charge £15,000 to organize an advisory board meeting which would give the company a “competitive edge”. He “offered to set up a trip to Dubai for 10 health officials, many of whom are involved in choosing the drugs their CCG or Trust offers to patients,” states Telegraph. 

UK Sunshine Act?

Currently, member companies of the Association of the British Pharmaceutical Industry (ABPI) are required to report transfers of value made to health care professionals to remain compliant with the EFPIA Disclosure Code. However, the Telegraph article notes that NHS England and Jeremy Hunt, the Health Secretary, have noted that the investigation “raised the question of whether the Government should legislate for full disclosure of payments made to health professionals.”

The UK news outlet Independent quoted the Department of Health as stating that “[i]f these allegations are true, this is completely outrageous and amounts to an abuse of the trust that patients place in NHS staff.”

An NHS England spokesman said: “These are extremely serious allegations so we have immediately directed NHS Protect to launch a full investigation of each and every case identified by this press report.”

“These allegations also raise the question of whether this country should now legislate for a so-called Sunshine Act, requiring full disclosure of any payments made by a pharmaceutical or device company to a health professional or NHS employee.”

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The scrutiny in these cases focused on employees of NHS, but pharmaceutical companies too must be weary of increased scrutiny into their interactions with payers abroad and potential bribery charges. While patients ultimately benefit when pharmaceutical companies can rely on the expertise of a diverse spectrum of consultants, care must be taken to keep these engagements transparent and avoid the extravagance alluded to here.  

 

July 24, 2015

Iceland Adopts EFPIA Disclosure Code

Iceland

Polaris has reported that Frumtök, the Icelandic Association of the Pharmaceutical Industry, has adopted the EFPIA Disclosure Code. Indeed, the Association’s website reveals that though Frumtök is “not a formal member of EFPIA we acknowledge the Disclosure Code and fully implement it, as we have done with the EFPIA HCP Code.” The announcement states that the Code came into force January 1, 2015. Frumtök has 18 member companies.  

As we have outlined in a number of articles, the EFPIA Disclosure code imposes Sunshine Act-like transparency obligations on all EFPIA members companies; currently there are 34 full members. The Code generally requires each member to document and disclose transfers of value made directly or indirectly to healthcare professionals and healthcare organizations. The first reporting period started January 1, 2015, with disclosure by June 30, 2016.

Jakob Falur Garðarsson, the Association's head, announced the changes in December, stating:

Implementation of the Disclosure Code is on track. We’ve had several meetings presenting the purpose and basic framework of the Code. The Code is clearly raising some questions within the HCPs community but the reactions, f.ex. from the heads of the National Hospital is both promising and positive. The Hospital’s governors and the Board of the Hospital’s Committee of Doctors accept and agree with the fundamentals of the Code and will actively help us promoting the Code. Similarly, we have received positive reaction from the Icelandic Medical Association.

Our member companies are understandingly asking how disclosure will be solved in Iceland. It is clear that each company will make its own decisions regarding its disclosures, but it has been decided that we will offer our member companies the service of publishing the Disclosure Reports on our website. The official EFPIA Disclosure template, The Template, has been translated in to Icelandic and will be made available for those who request it.

Here is the Disclosure Code template with English translation.

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