Does the widely disliked “Big Pharma” bribe doctors with free gifts and hospitality?

In this country at least, bribery is seldom carried out by anything so obvious as a brown envelope stuffed with used bank notes. Instead, it is made to seem respectable by invitations to conferences in comfortable hotels, where the ostensible purpose of the conference plays, shall we say, a subsidiary role to the quality of the spa and the cuisine.

The Human Medicines Regulations were introduced in 2012, with the aim of restricting such “respectable” bribery.

Unfortunately, there is reason to believe that they are not working.

The boundary between making purchasing decisions based upon persuasive marketing by pharmaceutical companies and making purchasing decisions because of financial or other inducements has always been a grey area for health service officials.

With huge sums of money and the significant purchasing power of Clinical Commissioning Groups (CCG’s), the desire of drugs companies to get their products purchased has resulted, according to an undercover investigation by the Daily Telegraph, in “disturbing” evidence of senior NHS managers being paid thousands of pounds and taken on expensive trips by firms lobbying to get their drugs used.

CCGs and Hospital Trusts make decisions on which medicines should be used across the country from GP surgeries to hospital wards. There are 209 CCGs operating in England and they control 60 per cent of the NHS’s annual budget some £60billion. The total NHS spend on medicines is around £7billion per year. The CCGs appoint committees to decide if healthcare providers should switch from one drug to another. Their decisions are supposed to be based on guidelines set by NICE, local budgets and their own experience.

In pharmaceutical circles, the health officials who take part in deciding what drugs are adopted are known as ‘payers’. The ‘payers’ tell doctors which medicines are ‘in,’ which are ‘out’, which should be introduced gradually, and which should be gradually reduced. Although an individual doctor is not bound to accept the CCG recommendations, the likelihood is that in most cases they will do so.

For pharmaceutical companies, getting their new drug at the top of a GP’s list of preferred products is of supreme importance. Companies promote their products to the ‘payer’ through gifts and hospitality. Perhaps unsurprisingly, the Telegraph investigation suggested that there was a direct connection between recommendations made by the ‘payers’ and the hospitality that they had received.

As a direct response to this investigation, Health Secretary Jeremy Hunt MP has declared that all NHS organisations will have to declare all gifts or hospitality staff receive from drug companies or face unlimited prosecution and jail time under a new government rule. Any member of staff who fails to declare full details of gifts they receive will face disciplinary action, and those guilty of accepting presents or luxury trips in exchange for drug influence within the NHS could be prosecuted under the Bribery Act.

The ‘Sunshine rule’, which will be mandatory from next year, will force all members of staff to keep a register of hospitality and gifts from pharmaceutical firms to crackdown on corruption in the state service. The concept of a ‘Sunshine rule’ originates in the US where it was introduced in 2013 in an attempt to root out corruption. It requires openness in government, making meetings and official actions available for public observation, participation and/or inspection.

The Telegraph reported Jeremy Hunt as saying that “Disturbing evidence has come to my attention that small numbers of NHS staff have tried to influence NHS purchasing decisions in turn 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 and the amount paid for drugs and products.” He added that the solution is greater transparency through tough new rules to “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.”

The Association of the British Pharmaceutical Industry (ABPI) welcomed the new rule and the opportunity to work with the Department of Health and NHS England to help develop it to ensure maximum combined efforts. Dr Virginia Acha, ABPI’s executive director, noted that the UK pharmaceutical industry has already been governed by a self-regulated code of practice for over 50 years that “provides a robust framework for acceptable levels of interaction” between firms and healthcare providers in relation to gifts and hospitality.

Mr Hunt’s response will mean strengthening sections 300 and 303 of The Human Medicines Regulations 2012:

300:

1. A person may not, in connection with the promotion of medicinal products to persons qualified to prescribe or supply them, supply, offer, or promise any gift, pecuniary advantage or benefit unless it is:
   • inexpensive and
   • relevant to the practice of medicine or pharmacy.
2. A person may not provide hospitality at a meeting or event held for the purposes of the promotion of a medicinal product unless:
   • the hospitality is strictly limited to the main purposes of the meeting or event; and
   • the person to whom it is provided or offered is a health care professional.
3. Nothing in this regulation shall prevent any person providing hospitality at an event held for purely professional or scientific purposes provided that:
   • the hospitality is strictly limited to the main scientific objective of the event; and
   • the person to whom it is provided or offered is a health care professional.
4. A person qualified to prescribe or supply medicinal products may not solicit or accept any gift, pecuniary advantage, benefit or hospitality that is prohibited by this regulation.
5. In this regulation “hospitality” includes (a) sponsorship of a person’s attendance at a meeting or event; and (b) the payment of travelling or accommodation expenses.

303:

1. A person is guilty of an offence if that person commits a breach of a provision in this Chapter.
2. A breach of a provision in this Chapter includes any
   • contravention by any person of any prohibition in this Chapter; and
   • failure by any person to comply with any requirement or obligation in this Chapter.
3. A person guilty of an offence under this regulation other than one to which paragraph (4) applies is liable
   • on summary conviction to a fine not exceeding the statutory maximum; or
   • on conviction on indictment to a fine, to imprisonment for a term not exceeding two years or to both.
4. This paragraph applies to an offence consisting of a breach of …(c) regulation 300(4) (solicitation or acceptance of inducements or hospitality).
5. A person guilty of an offence to which paragraph (4) applies is liable on summary conviction to a fine not exceeding level 5 on the standard scale.

Therefore, although the The Human Medicines Regulations 2012 ban the offering of gifts in connection with the promotion of medicines to anyone who is qualified to supply or prescribe medicines and they ban the receiving of such gifts, without openness and transparency on all gifts received, it is difficult for the boundary between perfectly proper marketing and advertising and corruption in relation to the purchasing of drugs to be properly monitored.

A sunshine rule, will introduced transparency by requiring CCG’s and hospital trusts to keep a register of all hospitality and gifts, so that the relationship between them and pharmaceutical companies can be properly scrutinised. Failures to adhere and declare may result in disciplinary proceedings or prosecutions for breaching the regulations or more significantly prosecutions under the Bribery Act 2010.