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Good relationships must come first

The new Bribery Act may deter interactions between the pharmaceutical industry and the NHS, but good relationships are essential for new product development and patient benefit

By Ron Pate and Martin Anderson

The new Bribery Act may deter interactions between the pharmaceutical industry and the NHS, but good relationships are essential for new product development and patient benefit

Surely no one is confused, right? It is straightforward: just play with a straight bat and you will stay out of trouble. But what does that mean? Some NHS professionals take it to mean that it is best to take no chances and have nothing to do with the pharmaceutical industry. These people need to ask how that helps the NHS get the industry to provide it with the products and services it needs.

Dialogue between NHS customers and the pharmaceutical industry benefits patients, NHS services and pharmaceutical companies. But does the plethora of guidance available support, confuse or even scare off NHS professionals? Has the NHS fully considered the impact of the new Bribery Act, the Association of the British Pharmaceutical Industry code of practice and NHS guidance?

Dialogue requires that parties meet and, realistically, not all meetings can take place in NHS time. Some will occur in the evening, at weekends or at conferences. Yet when this occurs suspicions are always aroused.
Hospitality appears to be a key issue. An article in the Independent on Sunday on 3 July 2011 reported that healthcare staff who influence how the NHS drug budget is spent say they are not swayed by hospitality. However, in the eyes of the public this does not pass the Mandy Rice-Davies “they would say that wouldn’t they?” test. And in the same article it was reported that a number of big pharmaceutical companies had breached the ABPI rules on hospitality.

For hundreds (maybe thousands) of years, whenever buyers and sellers meet and exchange goods, someone, somewhere, will cry foul. But should anybody in the NHS or pharmaceutical industry feel uncomfortable about meeting to discuss products and services? Many years ago abuse of the system did occur and both sides were to blame. It is for this reason that the call for greater transparency has grown.

Rules and regulations

From 2013 pharmaceutical companies that agree to comply with the ABPI code and sponsor NHS professionals to attend meetings (including those organised by third parties) must disclose the total paid in the previous year, including registration fees, cost of accommodation and travel outside the UK. How frequently do NHS employees disclose such information, and how difficult is it to get others to believe that received hospitality was proportionate to the occasion, “at a reasonable level” or “of a similar scale that they would be offered by their employer”? These quotations are from Department of Health guidance on “Standards of business conduct for NHS staff” and “Commercial sponsorship — ethical standards for the NHS”.

But should the pharmaceutical industry get all the blame? Surely the NHS professionals involved were an associated party? Do NHS professionals always remember to declare interests in relevant meetings or discussions?
Now along comes the new Bribery Act. The clue is in the name, which, simply interpreted, means that an offence is committed if a company offers (or a person seeks or takes) a reward (or promise of a reward) for the improper performance of a function for which they are employed. The Act goes into much more detail and lawyers will undoubtedly have a field day when cases come to court.

Earlier this year, the Ministry of Justice issued “Guidance about commercial organisations preventing bribery (section 9 of the Bribery Act 2010)”, which helps clarify what constitutes “reasonable and proportionate” hospitality and the kind of procedures that companies should have in place as a defence against charges of failing to prevent bribery.

The ABPI has said that it takes a “zero tolerance approach” to bribery and corruption and its 2011 code was strengthened in areas such as transparency and payments to health professionals. The code already exceeds the legal requirements of the Bribery Act on issues such as hospitality and transparency.

The Serious Fraud Office (SFO) has for a number of years been recommending stringent self-regulatory mechanisms and the ABPI code is seen as a global leader in this respect. The ABPI and the Prescription Medicines Code of Practice Authority have issued a memorandum of understanding with the SFO that addresses potential overlaps between the ABPI code and the Bribery Act (see www.pmcpa.org.uk). The SFO has expressed confidence in the ABPI code as an effective self-regulatory mechanism and is unlikely to intervene unless the matter is deemed serious enough to merit investigation.

The SFO and others agree that sensible and proportionate expenditure on hospitality is entirely legitimate and not outlawed by the Bribery Act. The self-regulatory mechanism that exists for pharmaceutical companies means they are quick to report other companies where they can (although different interpretations of the ABPI code by companies can cause confusion). Health professionals with concerns about pharmaceutical companies should also consider doing so, yet it seems that few NHS professionals are reported through their own regulatory bodies — for example, the General Pharmaceutical Council or General Medical Council — or to their NHS employers.

So will common sense be applied and everything declared? For example, surely a case of wine for Christmas from a supplier would be recognised as requiring declaration but a bottle of wine may not be by some (although, of course, neither would be allowed by a pharmaceutical company). One person’s interpretation of “proportional” and “reasonable” may be different from another’s. Similarly, a couple of glasses of wine in an average restaurant at a conference is one thing but enjoying numerous glasses of champagne at a Michelin-starred restaurant with entertainment is clearly another.

How to move forward

Where does all this take us? Will paranoia rule, with the NHS and the pharmaceutical industry never to meet again? If so, how does that help patients, the NHS and the pharmaceutical industry? If clinical trials are to take place and new products developed and used to meet patient needs then interaction between NHS professionals and the pharmaceutical industry is essential. The plethora of guidance adds to the justifiable concerns and deters many from such interaction. This does not help improve healthcare, nor the fast maturing business relationship between the NHS and the pharmaceutical industry. Another way is needed to support and encourage appropriate interactions between the NHS and the pharmaceutical industry which will ensure transparency.

Ron Pate Department of Medicines Management, Keele University

Martin Anderson Former ABPI director

Citation: The Pharmaceutical Journal URI: 11088907

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