It is well known that pharmaceutical representatives and their companies are bound by the Association of the British Pharmaceutical Industry (ABPI) Code of Practice (available at: pmcpa.org.uk), but what is the Code and what does it mean for those who work in the healthcare industry?1
Why is the Code necessary?
The Code is a voluntary set of rules put in place by the industry’s trade association: the ABPI. The aim of the Code is to ensure that the promotion of medicines to healthcare professionals is carried out within a robust framework to support high-quality patient care. However, the ABPI recognised that for the Code to have credibility, the industry could not regulate itself directly. An independent body—the Prescription Medicines Code of Practice Authority (PMCPA)—was created to administer the Code on behalf of the pharmaceutical industry, which it does at arms length from the ABPI. The PMCPA does its job well and protects its reputation for independence fiercely, as the rulings it issues will attest.
Each country regulates its pharmaceutical industry in different ways and while the UK Code has much in common with its overseas relatives, it is the oldest (50 years) and the most rigorously enforced. For example, whenever there is a complaint regarding the behaviour of a company, the details of the investigation are published in full by the PMCPA; serious transgressions actually result in advertisements in key medical journals such as the British Medical Journal.1
The Code is stricter than the Medicines (advertising) Acts2 in the obligations it places on pharmaceutical companies. There have been a number of instances in which the Medicines and Healthcare products Regulatory Agency (MHRA) has deemed promotional material to be acceptable, and yet it has subsequently been ruled in breach of the Code.
The Code encompasses all the promotional activities undertaken by a pharmaceutical company and also a wide range of non-promotional ones. In fact, the vast majority of the 25 clauses in the Code impact on primary care in one form or another. The key control mechanism within the Code is that all activities have to be formally reviewed by two senior or appropriately qualified individuals within the pharmaceutical company who ‘certify’ that the activity meets the requirements of both the Code and the Medicines Act. One of these two signatories must always be a GMC-registered medical practitioner.1 Therefore, every item used by sales representatives, all the advertisements placed in medical journals, and the mass of mailings received in general practice every week will have been reviewed by signatories.
Advertising in medical journals
Each medical journal is only permitted to contain a maximum of two pages of advertising for each product, and there are strict rules about what information the advertisement must (and must not) contain.1
Companies must be able to prove everything that is stated in an advertisement and in all material they issue. All statements have to be fair, unbiased, factually accurate, and in line with the product licence and they must not be misleading—companies may be called upon to prove that the product does what it claims. This means that if a new study is launched and the balance of evidence changes, the pharmaceutical company has to withdraw all relevant material and amend the wording to reflect the findings of the new study.1
The rules pertaining to claim structure also mean that the use of words and imagery is of paramount importance. Information and images should not be used out of context and must not send out incorrect messages (e.g. an advertisement that emphasises urgent decision-making in a condition that is not acute is a breach of the Code).
The Code dictates that healthcare professionals should only receive eight promotional mailings per year on each product, and the envelopes should be designed so that it is obvious that they contain promotional material rather than safety announcements.
The Code also encompasses data protection, and its legislation is tighter than that required by domestic law. In business-to-business marketing, companies do not need to obtain permission before sending promotional emails to people; pharmaceutical companies, however, must gain the permission of healthcare professionals. Furthermore, they have to be able to prove that the healthcare professional has personally given permission to receive promotional emails. Consenting to receive promotional emails is often an integral part of website registration.
Providing medical and educational goods and services
The Code regulates the involvement and actions of pharmaceutical representatives in a number of ways, including:
- their training
- what they are allowed to say
- how much they can earn
- the type of meetings they are allowed to run
- the venues they are permitted to use
- the budget they are allowed to spend on food.
The rules concerning how the pharmaceutical industry provides gifts, and medical and educational goods and services are primarily detailed in Clause 18 of the Code. For example, a company should not pay a GP practice for the hire of a room on their premises for the purposes of holding a meeting, but they are permitted to provide food. However, it is not acceptable to make a contribution to the practice ‘educational fund’ in lieu of food, and food should not be provided for anyone who was not present at the meeting.1
The NHS and the pharmaceutical industry
Despite the stringent clauses, the Code acknowledges that partnerships between the NHS and industry can be beneficial for patients. Clause 18 focuses specifically on the services that industry is allowed to provide. As long as these improve patient care, or benefit the NHS without harming patient care, then all manner of products are potentially acceptable. This clause in particular should be of great interest to primary care.
Pharmaceutical companies are usually keen to collaborate on projects that are related to their therapy areas. However, the Code is very strict and prevents companies from linking projects directly to a product. This includes treatment reviews to identify any patients that could benefit from a change in their therapy, or funding for a pilot cardiovascular service.
Any collaboration with a pharmaceutical company should:
- be transparent
- clearly display details of funding
- include a written agreement.
The contents of the written agreement will depend on the company involved, but could be in the form of a relatively informal letter summarising the main points or a five-page contract. The key thing is that the main points of the project need to be detailed, including the sums of money involved. There will usually be a statement separating the support from association with the company’s products (particularly highlighting that the company does not expect the practitioner to prescribe its products in return!).
The 2008 edition of the Code contains an increased emphasis on transparency and documentation, and it is reasonable to assume that this particular emphasis will become even more acute in future updates.1
Although pharmaceutical companies still provide support in the form of travel grants and help with educational courses, they are increasingly looking to move beyond funding for individual educational programmes. Instead they are seeking collaboration on projects that benefit the wider healthcare community—true ‘partnership working’ rather than merely funding. For example, one company has helped a primary care trust to set up a community care diabetes service. It provided funding for the pilot, training for the nurses, supported the development of the care pathways, and contributed to the running costs of the service. This raises the question of what the company will get in return? Clearly, the company hopes that its goodwill is recognised, and on a purely commercial basis, the more patients that are identified, the more opportunities there are for treatment with pharmaceutical products. Moreover, the company enhances its reputation for corporate responsibility.
The Department of Health (DH) has endorsed the concept of partnership working and has published Best practice guidance on joint working between the NHS and pharmaceutical industry and other relevant commercial organisations, which can be found on the DH website (www.dh.gov.uk).3 The main points can be summarised as follows:
- work to the benefit of patient care
- document details of any agreement
- industry involvement must be transparent.
Be aware that the obligations placed on the industry by the ABPI Code are stricter than those outlined for the NHS in the DH joint working guidance.
Information for patients and the public
The Code also covers activities that are non-promotional, including what companies can provide in terms of support for patients and ‘services to medicine’. It is in these two areas that infringements are most strictly punished. Disease awareness campaigns are allowed but it is not acceptable to provide information in such a way that patients are encouraged to ask for particular medicines. Companies have been ruled in breach of the Code for doing just that even if product names have not been mentioned.
More information on the ABPI Code of Practice can be found at: www.pmcpa.org.uk. Full reports of every complaint raised against the industry, complete with explanations for the rulings can also be found on the website. Voluntary the Code may be, but it is most certainly enforced!
About the author
The author is a compliance specialist who advises the industry and healthcare organisations on the ABPI Code and other compliance matters.
- Association of the British Pharmaceutical Industry. Code of practice for the pharmaceutical industry. London: ABPI, 2008. Available at: www.pmcpa.org.uk/?q=getcopiesofcode
- The Medicines and Healthcare products Regulatory Agency website: www.mhra.gov.uk/Howweregulate/Medicines/Advertisingofmedicines/Thelegislativeframework/index.htm
- Medicines, Pharmacy and Industry Group, Department of Health. Best practice guidance on joint working between the NHS and pharmaceutical industry and other relevant commercial organisations. London: DH, 2008.G