Life Science Compliance Update

September 03, 2015

EFPIA Files Complaint Against French Law Promoting Off-Label Avastin Use


Earlier this week, EFPIA, Europe's pharmaceutical industry association, announced it had filed a complaint with the European Commission against the French “RTU Regime.” promoting the use of Roche's cancer drug Avastin for the off-label treatment of wet age-related macular degeneration (AMD). The decree allows the French medicines regulator (ANSM) to issue a temporary authorization for use of a product in an unauthorized indication, purely for economic purposes, notwithstanding the existence of an authorized alternative treatment. This development is troubling and contravenes European Community law and jurisprudence, writes EFPIA, along with EUCOPE and EuopaBio. “The regime allows [ANSM] to issue a temporary authorisation for use of a product in an unauthorised indication, also for economic purposes, notwithstanding the existence of an authorised alternative treatment,” the trade groups wrote in their recent press release. “This development is troubling and contravenes European Union law and jurisprudence.”

View the trade groups' Press Release here

While Roche's Avastin is not approved by health regulators as a treatment for AMD, it works in a similar way to the treatments currently authorized for AMD, such as Lucentis, marketed by Novartis and Roche, and Eylea, from Bayer and Regeneron. France has argued that encouraging the use of Avastin, which costs around 30 times less than those rival treatments, could result in annual savings of some 200 million. The most publicized switch has traditionally been Avastin for Lucentis--doctors have prescribed Avastin for AMD because it is much cheaper and according to publicly-funded trials is as effective as as Lucentis. See, for example, a 2013 Washington Post article entitled “An effective eye drug is available for $50. But many doctors choose a $2,000 alternative.”

The price and comparable effectiveness of off-label AMD treatment is one side of the story; EFPIA also argues that such legislation may put lawmakers in charge of medical decision-making. “It is simply not acceptable for policy makers concerned with the size of healthcare spending to introduce legislation that not only contradicts EU law, but also puts the overall EU regulatory system aimed at guaranteeing the highest patient safety standards at risk," said EFPIA director general Richard Bergstrom. (See Reuters) "The pharmaceutical industry collectively calls on the European Commission to address this public health issue urgently and preserve those safeguards that have been put in place.”

“Off-label prescribing of medicines should only occur in very specific situations where there is no approved therapeutic alternative and making sure that all safety measures and precautions have been respected,” EFPIA adds. “Furthermore, patients should be made fully aware of the risks associated with the use of an off-label medicine and explicitly consent to its prescription.”


August 25, 2015

UK Health Secretary Announces Mandatory "Sunshine Rule" After Investigation Into Industry Relationships With NHS Employees


Yesterday, British Health Secretary Jeremy Hunt announced that all National Health Service hospitals and General Practitioner groups will be required to keep a list of every gift and payment from pharmaceutical companies to health service staff. Under the new “Sunshine Rule,” NHS personnel who receive such benefits from drug companies will have to declare them or face dismissal and potentially jail time.

The British Health Secretary’s decision was spurred by a recent Telegraph investigation which found evidence of senior NHS directors soliciting thousands of pounds for consulting work, and other officials speaking about company-sponsored advisory board meetings held in luxurious hotels. Read our article highlighting the undercover investigation here.

In response to the Telegraph article, Hunt released the following statements (DailyMail):

Disturbing evidence has come to my attention that small numbers of NHS staff have tried to influence NHS purchasing decisions in return for payment, gifts or hospitality from pharmaceutical firms and medical device manufacturers.

This is a complete abuse of their position and will be shocking to the vast majority of staff who want the best for patients.

Part of the problem is just how many sales reps are targeting our hospitals, with 65 reps on site at any one time according to a recent report. The NHS is indirectly paying for every one of those reps, through staff time and the amount paid for drugs and products.

As with so many issues in the NHS, the answer is greater transparency. These tough new rules will for the first time expose improper relationships between staff and pharmaceutical companies. Only those serving their own self-interest should have anything to fear, with patients and taxpayers set to benefit.

It is unclear at this time whether the penalties would be under the already existing UK Bribery Act or new legislation specifically aimed at disclosure requirements.

Hunt's announcement comes during the first year of reporting under the European Federation of Pharmaceutical Industries and Associations (EFPIA) Disclosure Code. While the EFPIA Disclosure Code is a self-regulatory, rather than legislative, measure, it requires requires all 40 EFPIA member companies and all members of the 33 EFPIA associations to disclose transfers of value to healthcare professionals (HCPs) and healthcare organisations (HCOs). 

The Association of the British Pharmaceutical Industry (ABPI) responded to Secretary Hunt's announcement, saying it welcomes the "Sunshine rule" as a positive addition to the industry’s current disclosure initiative. While the ABPI Code “already has strict requirements on the interaction between sales representatives and healthcare professionals”, the Association said it would “welcome the opportunity to work with the Department of Health and NHS England as plans for the ‘Sunshine Rule’ develop." 

The ABPI also touted its stringent self-regulatory measures:

We have led the way with the disclosure of payments to healthcare professionals in the UK since 2012 when we began publishing aggregate payments made by industry to doctors, nurses and other healthcare professionals. Our latest initiative will see the publication of payments and transfers of value made by industry to individual healthcare professionals and healthcare organisations during 2015 made public in June 2016 on a single, searchable database hosted by the ABPI.


It appears that whilst declarations of gifts and hospitality made under the proposed Sunshine Rule signal a common ambition for greater transparency in our relationships, it will cover just a small proportion of the important interaction between industry and HCPs in comparison to our own disclosure requirements. For that common ambition for greater transparency to really improve relationships between healthcare professionals and industry, we also need to align on the great value of those relationships to deliver advances in science and treatment for patients, including research.  We have always maintained these interactions are a critical part of advancing improved healthcare outcomes for patients within appropriate and transparent governance frameworks.

For more information on ABPI's disclosure measures click here. We will continue to follow any "Sunshine Act" type legislative developments in the UK. View their recent press release entitled "ABPI welcomes Jeremy Hunt’s ‘Sunshine Rule’ as a positive addition to industry’s disclosure initiative." 

See the Telegraph article on the Hunt's latest announcement here

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.”


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.  



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