Principles and Overview of Self Regulation and Introduction to Code
Principles and Overview of Self Regulation - newly introduced in the 2019 Code
- The pharmaceutical industry in the United Kingdom is committed to benefiting patients by operating in a professional, ethical and transparent manner to ensure the appropriate use of medicines and support the provision of high quality healthcare.
- Patient safety is the priority. All information relating to safety must be shared accurately and transparently.
- The aim of the Code is to ensure that the promotion of medicines to health professionals and other relevant decision makers and other activities are carried out within a robust framework to support high quality patient care.
- Prescription only medicines must not be promoted to the public.
- Working with patients and patient organisations can bring significant public health benefits.
- Information about prescription only medicines made available to the public must be factual, balanced, not misleading and must not encourage prescription of a specific prescription only medicine.
- Whilst the industry has a legitimate right to promote medicines to health professionals, the Code recognises and seeks to balance the needs of patients, health professionals and the public, bearing in mind the environment within which the industry operates and the statutory controls governing medicines.
- The Code supports the prescribing decisions of health professionals.
- Transparency is an important means of building and maintaining confidence in the pharmaceutical industry.
- Companies must ensure that their materials are appropriate, factual, fair, balanced, up-to-date, not misleading and capable of substantiation and that all other activities are appropriate and reasonable. Promotion must be within the terms of the marketing authorization and not be disguised. Material must be tailored to the audience.
- Companies are responsible under the Code for the activities of their staff and third parties. Training must be provided.
- It is a condition of membership of the ABPI to abide by the Code in both the spirit and the letter. In addition many non member companies agree to comply with the Code and accept the jurisdiction of the PMCPA.
- Any complaint made against a company under the Code is regarded as a serious matter both by that company and by the industry as a whole. Sanctions are applied against a company ruled in breach of the Code.
Introduction to the Code of Practice 2019
Promoting Appropriate Use of Medicines
The pharmaceutical industry in the United Kingdom is committed to benefiting patients by operating in a professional, ethical and transparent manner to ensure the appropriate use of medicines and support the provision of high quality healthcare. This commitment applies to all with whom the industry interacts.
To demonstrate this commitment over 50 years ago, in October 1958, the Association of the British Pharmaceutical Industry (ABPI), which represents the UK industry, decided that certain activities should be covered in detail and thus agreed the first ABPI Code of Practice.
The Code covers the promotion of medicines for prescribing to both health professionals and other relevant decision makers. It also includes requirements for interactions with health professionals. In addition it sets standards for the provision of information about prescription only medicines to the public and patients, including patient organisations.
In addition to the Code there is extensive UK and European law relating to the promotion of medicines. The Code reflects and extends beyond the relevant UK law.
The aim of the Code is to ensure that the promotion of medicines to health professionals and other relevant decision makers is carried out within a robust framework to support high quality patient care. As well as covering promotional material, it controls samples, meetings, promotional aids, the provision of medical and educational goods and services, outcome or risk sharing agreements, patient access schemes, joint working between the pharmaceutical industry and the NHS, the conduct of non-interventional studies, the use of health professionals and other relevant decision makers as consultants and transfers of value to health professionals, other relevant decision makers and healthcare organisations. The Code also sets standards relating to the provision of information to patients and the public as well as relationships with patient groups.
The industry considers that provided the requirements of the Code are met, working with patients and patient organisations can bring significant public health benefits. These requirements also apply to working with all user groups, such as disability associations, relative and carer associations and consumer associations.
In summary, companies must ensure that their materials are appropriate, factual, fair and capable of substantiation and that all other activities are appropriate and reasonable.
Ensuring High Standards
The detailed provisions in the Code are to ensure that pharmaceutical companies operate in a responsible, ethical and professional manner. Whilst the industry has a legitimate right to promote medicines to health professionals, the Code recognises and seeks to achieve a balance between the needs of patients, health professionals and the public, bearing in mind the political and social environment within which the industry operates and the statutory controls governing medicines.
The availability of accurate up-to-date information is vital to the appropriate use of medicines. Pharmaceutical companies must ensure that enquiries about their medicines are answered appropriately in a timely manner.
Strong support is given to the Code by the industry with all companies devoting considerable resources to ensure that their activities comply with it. Any complaint made against a company under the Code is regarded as a serious matter both by that company and by the industry as a whole. Sanctions are applied against a company ruled in breach of the Code.
Companies must ensure that all relevant personnel are appropriately trained in the requirements of the Code and must have robust operating procedures under which all materials and activities covered by the Code are reviewed to ensure compliance both with the Code and with the appropriate legal requirements. The Code incorporates the principles set out in:
- the International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA) Code of Practice
- the European Federation of Pharmaceutical Industries and Associations’ (EFPIA) Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals
- the EFPIA Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations
- the EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations
- the World Health Organisation’s Ethical Criteria for Medicinal Drug Promotion
- Directive 2001/83/EC on the Community Code relating to medicinal products for human use, as amended by Directive 2004/27/EC
- The Human Medicines Regulations 2012 (2012 No.1916), as amended.
The Code covers the industry’s activities only. However those interacting with industry as individuals or organisations also have a responsibility to ensure that their interactions comply with relevant legal requirements and are asked to follow the Code where relevant and not make requests that are not in accordance with the Code. Most of those interacting with the industry, other than patients, are covered by a selection of professional codes and guidance. For example, the General Medical Council ‘Good Medical Practice’, the General Pharmaceutical Council ‘Standards of conduct, ethics and performance’ and the Nursing & Midwifery Council ‘Standards of conduct, performance and ethics for nurses and midwives’. Patient organisations are likely to be covered by Charity Commission rules as well as their own codes. The pharmaceutical industry takes note of all relevant codes and guidance as well as the ABPI Code.
Transparency
The industry recognises that transparency is an important means of building and maintaining confidence. The operation of the Code, including the complaints procedure, is a demonstration of the industry’s commitment to transparency as are the requirement to declare pharmaceutical company involvement in activities and materials and the publication of detailed reports of cases considered under the Code. The industry’s global agreement to disclose certain clinical trial data is another example of the industry’s commitment to transparency. Companies also have to publish the summary details and results of non-interventional studies as well as the monetary value of certain support to patient organisations.
Other transparency changes, effective in 2012 and 2013, included disclosure of the total amount of fees paid to consultants for certain services and the total amounts paid to sponsor attendance at meetings organised by third parties. As set out in the 2014 Code, starting in 2015 transparency will be extended in relation to disclosure of fees and sponsorship provided to health professionals and healthcare organisations, including naming the recipients in many instances. The 2015 data will be disclosed in 2016.
Sanctions
In each case where a breach of the Code is ruled, the company concerned must give an undertaking that the practice in question has ceased forthwith and that all possible steps have been taken to avoid a similar breach in the future. An undertaking must be accompanied by details of the action taken to implement the ruling. At the conclusion of a case a detailed case report is published.
Additional sanctions are imposed in serious cases. These can include:
- the audit of a company’s procedures to comply with the Code, followed by the possibility of a requirement for the pre-vetting of future material
- recovery of material from those to whom it has been given
- the issue of a corrective statement
- a public reprimand
- advertising in the medical, pharmaceutical and nursing press of brief details of cases in which companies were ruled in breach of Clause 2 of the Code, were required to issue a corrective statement or were the subject of a public reprimand
- suspension or expulsion from the ABPI.
Monitoring of Activities and Guidance
The Prescription Medicines Code of Practice Authority (PMCPA) arranges for advertising and meetings to be regularly monitored. The PMCPA also provides informal guidance about the Code and its operation.
Promoting Health
The commitment of Britain’s pharmaceutical industry to providing high quality effective medicines brings major benefits to both the nation’s health and economy.
Investment into researching and developing new products in the UK is now running at over £4.2 billion a year and each new medicine takes over twelve years to develop before it is authorized for use, with no guarantee of commercial success.
The Association of the British Pharmaceutical Industry and its Code of Practice
The Association of the British Pharmaceutical Industry represents innovative research-based biopharmaceutical companies, large, medium and small, leading a new era of biosciences in the UK.
The industry is a major contributor to the economy of the UK. The ABPI represents companies which supply around 90% of all medicines used by the NHS, and are researching and developing the majority of the current medicines pipeline.
The Code has been regularly revised since its inception in 1958 and is drawn up in consultation with the British Medical Association, the Royal Pharmaceutical Society, the Royal College of Nursing, the Medicines and Healthcare Products Regulatory Agency of the Department of Health, the Competition and Markets Authority and the Serious Fraud Office. Anyone is welcome to send suggestions for amendments or additions to the Code to the PMCPA.
It is a condition of membership of the ABPI to abide by the Code in both the spirit and the letter. The Code applies to both members and affiliate members of the ABPI. Companies which are not members of the ABPI may give their formal agreement to abide by the Code and accept the jurisdiction of the PMCPA and over sixty have done so. Thus the Code is accepted by virtually all pharmaceutical companies operating in the UK.
Administering the Code of Practice
The Code is administered by the PMCPA which is responsible for the provision of advice, guidance and training on the Code as well as for the complaints procedure. The PMCPA operates independently of the ABPI itself. The relationship between the PMCPA and the ABPI is set out in a protocol of agreement. Financial information about the PMCPA is published in its Annual Report.
PMCPA publications can all be found here on its website www.pmcpa.org.uk or are supplied on request.
Complaints under the Code are considered by the Code of Practice Panel and, where required, by the Code of Practice Appeal Board. Reports on completed cases are published by the PMCPA in its Code of Practice Review and on its website. The PMCPA also publishes a list of ongoing cases on its website.
How to Complain
Complaints should be submitted to the Director of the Prescription Medicines Code of Practice Authority, 7th Floor, Southside, 105 Victoria Street, London SW1E 6QT, telephone 020 7747 8880, email complaints@pmcpa.org.uk.
