Good Pharmaceutical Medical Practice and GPMP Support Network

GPMP 2.0 complements existing international and national legislation^i-vii, with the UK General Medical Council (GMC) Good Medical Practice 2013^viii as its foundation. GPMP 2.0 extends upon the principles first outlined in FPM forerunner Good Pharmaceutical Medical Practice 2008^ix (updated 2014^x).

GPMP 2.0 reflects advances in practice and broadens the scope to encompass the increasingly complex, diverse roles of pharmaceutical physicians. This version is intended to be read alongside Good Medical Practice^viii.

Pharmaceutical medicine involves the discovery, development, licensing, marketing and safety monitoring of medicines, diagnostics, medical devices and advanced therapy medicinal products. Pharmaceutical medicine also involves legal, ethical, regulatory and business activities. It is practised in diverse environments, including academic centres, clinical trial units, pharmaceutical, biotechnology, and service companies, regulatory authorities. GPMP 2.0 applies in all these settings.

The responsibility of doctors working in pharmaceutical medicine extends to all individuals whose care may be affected by their actions. Although many doctors practising pharmaceutical medicine do not have direct patient contact, patient safety and well-being must always be a doctor’s primary concern.

Probity, namely adherence to the highest ethical principles and ideals, is at the centre of the practice of medicine. Pharmaceutical medicine requires a duty of care to society, with respect to the research and delivery of medical interventions. There may be a conflict between commercial pressures and ethical requirements. Whenever there are concerns regarding ethical practice, patient safety and data integrity, these must be highlighted to the appropriate governance structure. You must act as an advocate for patients.

GPMP is a guidance rather than a statutory code. However, throughout this document the definitions of ‘you must’ and ‘you should’ apply as described in Good Medical Practice:

‘You must’ is used for an overriding duty or principle.

‘You should’ is used when we are providing an explanation of how you will meet the overriding duty.

‘You should’ is also used where the duty or principle will not apply in all situations or circumstances, or where there are factors outside your control that affect whether or how you can follow the guidance.

You should use GPMP 2.0 as an adjunct to Good Medical Practice when registered with the GMC and/or revalidating in the United Kingdom. For all other doctors working in pharmaceutical medicine, you should use the principles of GPMP 2.0 as the standard to judge your practice against.

Throughout this document, the term ‘patient’ means those who might receive or are receiving a licensed or unlicensed medical intervention, including in clinical trials. The term ‘patient’ is used to mean both healthy volunteers and people living with disease.

A medical intervention may include a medicine, vaccine, diagnostic or device used in the diagnosis, treatment or prevention of disease.

Patients must be able to trust doctors with their lives and health. You are accountable for your professional practice and must be prepared to justify your decisions and actions. You must be prepared to explain and justify your personal contribution to decisions made by a team that may affect the safety and well-being of patients.

To justify the trust of patients you must show respect for human life and make sure your practice meets the standards expected of you in four domains:

Knowledge, skills and performance

https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-medical-practice/domain-1—knowledge-skills-and-performance

Safety and quality

https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-medical-practice/domain-2—-safety-and-quality

Communication, partnership and teamwork

https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-medical-practice/domain-3—communication-partnership-and-teamwork

Maintaining trust

https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-medical-practice/domain-4—maintaining-trust

• You must keep your professional knowledge and skills up to date.
• You must take steps to monitor and improve the quality of your work.
• You should demonstrate your involvement in learning and how this will positively affect your future practice of pharmaceutical medicine.
• You should maintain membership of, or be associated with, one or more professional bodies relevant to your practice of pharmaceutical medicine.

• Pharmaceutical medicine may affect clinical care in situations such as clinical trials. Information provided to healthcare professionals and patients must facilitate objective clinical decision-making based on full information of the benefit-risk profile and safety of available medicines.
• You must be satisfied that you have consent or other valid authority before you carry out any examination or investigation, provide treatment or involve patients or volunteers in teaching or research^xi.
• You must ensure that the scientific motivation for a clinical trial is clear, that the proposed intervention is scientifically justified, that the trial is designed to provide information on the safety and efficacy of the intervention and to have a reasonable probability of answering the research question.
• Research may also include experimental treatments where the benefit-risk profile has not yet been clearly established and/or is evolving. If the effects of a treatment are unclear, this uncertainty must be conveyed to the patient. If the benefit-risk profile has changed during the development programme, you must share this with the involved patients. If necessary, you must obtain further consent from the patients participating in the research.^xi

• Documents, including clinical records, used to formally record your work must be clear, accurate and legible. You should make records at the time of the event or as soon as possible afterwards.
• You must keep records that contain personal information about patients, colleagues or others securely, and in line with any data protection requirements.^xii
• Accurate documentation is essential to the practice of pharmaceutical medicine and working with a pharmaceutical organisation. Good Clinical Practice,^xiii Good Pharmacovigilance Practice,^xiv Good Laboratory Practice^xv-xvi, Good Manufacturing Practice^xvii and International Conference on Harmonisation (ICH) Guidelines^xviii are the essential operational guidelines.

• Medical input should be provided to ensure the safety of patients and optimise the benefit-risk balance of a drug.
• You should take account of feedback from other individuals and groups, including healthcare professionals, regulatory bodies and organisations representing patients, and, when needed, undertake quality improvement programmes.
• You must include appropriate safety monitoring in the design of a clinical trial, according to the level of knowledge and risk associated with the intervention.
• You must take additional care when investigating interventions with a novel mechanism of action, particularly those that target the immune system or with a potential for biological amplification.
• You should ensure that populations recruited to clinical trials are not exposed to undue risk due to underlying comorbidities, or cognitive or communication difficulties.
• You should consider the needs of vulnerable or marginalised populations and, where appropriate, ensure that they are not excluded from clinical research in areas relevant to them, either pre- or post- regulatory approval, recognising the special care that must be taken.
• You should share clinical trial results, both positive and negative, in a timely manner to reduce unnecessary studies and enhance patient safety.

• At all stages of the life cycle of a medicinal product or medical device, patient safety must be your primary concern. When reviewing results, you must always consider the needs of the individual patient and the protection and promotion of public health.
• You should consider data from all sources in the regular monitoring of product safety. You should promptly investigate safety signals in an unbiased manner and manage incidents that could affect patient well-being, e.g. product quality issues.
• You must take prompt action when you believe that patient safety may be compromised. You must report adverse events and other safety concerns to the relevant regulatory agencies according to company procedures and local legislative drug safety requirements. You must cooperate with official investigations in relation to patient safety.^xix
• You must communicate safety information appropriately to healthcare professionals and patients, according to the level of risk posed e.g. through drug-safety alerts, Direct Healthcare Professional Communication (DHPC) letters or updates to the product information.

Further reading:

https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/raising-and-acting-on-concerns/part-1-raising-a-concern

https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/raising-and-acting-on-concerns/part-2-acting-on-a-concern

• You must listen to patients, take account of their views, and respond honestly to their questions.^xi
• You must presume that every adult patient has the capacity to make decisions and make reasonable adjustments to support patients to understand information. When it is determined that a patient lacks capacity, is vulnerable and/or unconscious, you should listen to the views of anyone who has been appointed to represent the patient. You should take account of the carers’ views and respond honestly to the carers’ concerns.
• You should involve children and young people as much as possible in decision making processes and assess their capacity to consent. You must ensure that parents or legal representatives understand all the information when they are asked to consent on behalf of the child or young person. (http://www.hra-decisiontools.org.uk/consent/principles-children-EngWalesNI.html; https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/0-18-years/making-decisions)
• You should ensure that patients’ perspectives are included during the clinical development of medicines.
• You should anticipate the information needs of patients in the preparation of communications such as informed consent forms, patient information leaflets, patient support materials and social media. These should be accurate, complete and expressed in terms that are easily understood and not misleading. In relation to informed consent for clinical trials, there should be additional checks to ensure that the information provided has been fully understood, prior to consent being obtained^xvii
• The promotion of medicines must be based on ongoing assessment of all the available information and be in accordance with the labelling. Information provided to healthcare workers should permit objective clinical decision-making based on the merits of available products.
• You must be readily accessible for safety issues and medical monitoring activities, to take responsibility or provide information, advice and support as appropriate.

• Pharmaceutical medicine is practised as a global specialty. Consideration of cultural and linguistic differences is important at a regional, national and international level. You have a professional responsibility to embody and demonstrate the highest standards of integrity.
• Pharmaceutical physicians should work closely with colleagues from other disciplines, including scientific and non-scientific staff, with the goal of patient benefit and improving public health.

• To support the development and use of treatments, you should contribute to the training of medical and non-medical staff. This will help to ensure that they have appropriate knowledge in pharmaceutical medicine and promote patient safety.
• Senior pharmaceutical physicians should take a leadership/ mentoring role^xx and demonstrate, by their own behaviour, what good pharmaceutical medical practice.

• Patients and their representatives can offer unique insights into disease and illness. You have an obligation to work with patient advocates in the interests of public health. Care should be taken to manage potential conflicts of interest. Transparency is important when pharmaceutical physicians interact with patient groups.
• You must work in partnership with patients, sharing with them the information they will need to make decisions about their care, including any additional information patients need if they are asked to agree to be involved in research^xi. Information provided should include:
  • Purpose of the research
  • Benefits to the subject and society
  • Risks and additional burdens involved
  • Alternative treatments available to the participant
  • The option to discontinue participation without their care being affected

• You must only share individual patient data with others after obtaining relevant consent and taking measures to protect patient privacy. If, in exceptional circumstances, information must be passed on without consent, the process should follow the guidance of regulatory and ethical bodies and the decision to do so be justified.

• An apology is an expression of regret that an event has occurred and is not necessarily an admission of liability or guilt. If a patient has suffered harm, then you should express regret and empathy.^xix
• When conducting clinical research, it is often not possible to predict an adverse event or side effect of treatment or to be able to fully explain the likely long-term effects. It is important to express this uncertainty before treatment and not give unfounded reassurance.

• Patients should be treated fairly and, if required, treatment should be altered for the benefit of the patient with the patient’s consent.

• The patient must have had opportunity to consider relevant information, including the risks of harm and potential benefits of the proposed option, and the patient’s perspective on benefit-risk should be incorporated in shared decision making^xi.

• You should demonstrate leadership in the promotion of probity, namely the adherence to the highest ethical principles and ideals, wherever you practise.

• Pharmaceutical medicine is practised globally; you must ensure that you have adequate insurance or indemnity cover for all the jurisdictions in which you are working.
• You must ensure that the clinical trial sponsor holds adequate insurance for the study before the enrolment of patients.
• You should select investigational sites based upon the principles of ethics and probity outlined herein and consider the ongoing provision of treatment and care once patients have completed the study.

• You should give special consideration to the design and conduct of clinical trials in the developing world because of the complex ethical and public health issues^xxi.

• If you are an investigator in a clinical trial, you must consider the likelihood of the individual completing the study as part of the enrolment process.

• You must declare all competing interests that might influence your ability to make balanced, unbiased judgements of importance to patients or research subjects.
• You must be prepared to speak out if there is a conflict between patient safety and commercial interests.

• Communications should be timely and well considered, involving relevant stakeholders and developed in the interests of patients.
• You must ensure that all communications comply with local regulations and standards and, where applicable, codes of promotional practice^xxii.
• You are required to comply with national and international legislation relating to clinical trial disclosure. The following principles relating to disclosure and dissemination of information should be followed:
  • Timely registration of all clinical trials.
  • Timely communication of overall clinical trial results to all participants
• Summary results must be made public as soon as possible after completion of a clinical trial. The date of release of information should not depend upon the trial results, market or pricing approval or the continuation or discontinuation of the clinical trial or the whole project.
• Release of anonymised patient-level data to third parties must be in line with national and international regulations^xxiii.
• Promotional materials and/or information destined for patients, healthcare professionals, and pricing and reimbursement bodies must be complete, balanced and easily understood by the intended audience. Information for patients must be factual and take account of a patient’s potential vulnerability or lack of medical knowledge.

• Integrity in financial and business dealings is a fundamental principle of pharmaceutical medicine. You must operate within applicable local and international laws, regulations and guidelines relating to sponsorship, gifts, hospitality and the provision of grants and services allied to medical care^xxiv.