The primary focus of the Orthopaedic profession is to provide excellence in patient care and the BOA expects its members to maintain the highest standards of professionalism, integrity, and ethical behaviour.
It is recognised that collaboration between clinicians and industry is important in advancing and improving patient care. Industry often supports the development of new technologies, research, innovation and the continuing education of orthopaedic surgeons. It is clear in all commercial relationships that promotional expenditure and sponsorship can be used to influence the behaviour of individuals and it is in the interests of clinicians and the medical industry to ensure that this does not occur and that the relationship is totally transparent to outside inspection.
The UK Government has given specific advice upon the place of promotional expenditure and sponsorship in guidance issued relating to the new Bribery Act, which came into force in April 2011. The guidance suggests that “reasonable and proportionate promotional expenditure which seeks to improve the image of a commercial organisation, better to present products or services, or establish cordial relations, is recognised as an established and important part of doing business.” The act does not seek to criminalise normal and reasonable hospitality. Hospitality is unlikely to breach the Act if it is reasonable and proportionate, has a bona fide business purpose and is not intended to inappropriately influence an individual.
The practice of medicine inherently presents potential conflicts of interest. There is nothing intrinsically unethical in finding oneself in a position of conflict of interest, however the conflict must be recognised and managed appropriately. When conflicts arise the interests of patients, whose ethical treatment is the primary focus of the orthopaedic profession, should always be placed above secondary gains.
Surgeons have an obligation to disclose any conflicts to patients, colleagues and/or the public. They must strive to resolve any interest by maintaining a professional relationship with patients and always acting in their best interest.
A positional interest occurs when the clinicians or his/her family member has any form of relationship with a company with which the clinician has or is considering a transaction or arrangement.
Clinicians must always act in the best interest of patients when recommending or using medical devices. Any potential conflict of interest associated with a patient’s care must be declared to the patient, or to their representative, to allow them to make an informed decision about their care. Reasonable treatment alternatives or the further opinion of a clinician with no conflict of interest should be offered to ensure the most appropriate care is provided. If a conflict cannot be resolved satisfactorily, the clinician should consider notifying the patient of their intention to withdraw from the relationship.
Clinicians with a financial or ownership interest in a medical goods provider, image centre, surgery centre, or other health care facility must declare their financial interest to patients ‐ especially if their financial interest is not immediately obvious.
• Seek gifts, money or other benefits from industry exceeding an individual value of £20
• Accept any direct or indirect financial inducement from industry for using a particular implant or for switching from one manufacturer’s product to another.
Formal collaboration with industry should always be for sound, ethical research with local peer review and/or ethics committee approval. Finders fees and related schemes are not acceptable. Questions concerning the probity of research arrangements are best dealt with by full disclosure and by accessing ethics review board expertise.
The BOA recognises the need for a collaborative role with industry for the education of its members.
CME accredited educational events
In general, clinicians and their families should not accept industry funding, or other associated enticements, to attend CME accredited educational events, unless this is part of an established approved and openly declared fellowship or bursary programme.
Industry organised meetings / Education about new techniques/products
Surgeons wishing to learn a new technique or how to use a new product, should not accept funding from industry unless attendance at the educational event is approved by their local hospital or department. The focus of the event must be education and only tuition, travel and reasonable hospitality can be accepted. In no case should honoraria be accepted – unless the surgeon is part of the faculty (see below).
If a member is part of the faculty or the organising committee, where a recompense in the form of payment, subsidy or otherwise is received, such recompense should be limited to appropriate expenses and payment consistent with fair market value for time dedicated to the meeting. At all times such payments must be able to withstand public scrutiny. Any such financial arrangement must be disclosed to meeting participants.
CME accredited educational meetings organised by BOA members
Industry donations to a convening body organising an educational event to help lower the costs of the meeting are acceptable provided donations are publicly acknowledged in printed announcements. The convening body, not industry, must ultimately determine the location, curriculum, faculty and educational methods of the conference or meeting. They must at all times retain control over all aspects of the meeting.
Presentations and publications
Clinicians must acknowledge industry support in any publication or presentation of research results, accompanied by a declaration of the potential conflict of interest. In all presentations, these acknowledgements and declarations of interest must be made at the beginning of the presentation.
Abstracts submitted for all educational meetings must include acknowledgements of industry support and any potential conflict of interests. A list of the possible disclosures is given at the end of this document.
Industry support for UK Fellowships should be funded through a third‐party. Such third parties may include the BOA, public and private hospitals, universities, research and educational institutions, philanthropic associations or other organisations associated with the provision of health care.
Residency/Fellowship Training Programmes can receive unrestricted industry grants or support for specific activities as long as there is full, transparent disclosure by the program of the sources of support through some local processes (e.g. on meeting materials, annual reports, website, etc).
All donations by industry must be publicly acknowledged.
The training, research and education of Orthopaedic surgeons of all grades are covered by this BOA position statement.
The Executive, Council and affiliated Committees of the British Orthopaedic Association
All clinicians or affiliated professionals, who are elected to posts within the BOA, or work within the organisation at the request of Council, must declare and register any potential conflicts of interest on an annual basis. There shall be a public record of these declarations on the BOA website. At all BOA affiliated scientific meetings one of the following statements should me made on a slide at the beginning of each presentation:
1. The author or one or more of the authors have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this presentation.
2. The author or one or more of the authors have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this presentation. In addition, benefits have been or will be directed to a research fund, foundation, educational institution, or other non-profit organisation with which one or more of the authors are associated.
3. Although none of the authors has received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this presentation, benefits have been or will be received but will be directed solely to a research fund, foundation, educational institution, or other non-profit organization with which one or more of the authors are associated.
4. No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this presentation.
5. The author or authors choose not to disclose whether any personal or non-personal pecuniary interest exists.
Declarations of Interests required by the BOA:
A personal pecuniary interest involves a personal payment. The main examples include the following:
Any consultancy, directorship, royalty agreement, position in or work for a healthcare industry that attracts regular or occasional payments in cash or in kind.
Any fee-paid work commissioned by a healthcare industry for which the individual is paid in cash or in kind.A non-personal pecuniary interest involves payment or other benefit that benefits a department or organisation with which an individual is associated, but which is not received personally. The main examples include the following.
The holding of a fellowship endowed by the healthcare industry.
Any payment or other support by the health industry that does not convey any pecuniary or material benefit to an individual personally but that might benefit him or her.
a grant from a company for the running of a unit or department with which a member is associated
a grant or fellowship or other payment to sponsor a post or member of staff in the unit with which a member is associated
the commissioning of research or other work by, or advice from, staff who work in a unit with which the member is associated
An individual covered by this Code is under no obligation to seek out knowledge of work done for, or on behalf of, the healthcare industry within the departments with which they are associated if the relationship is distant such that the member would not normally expect to be informed of that relationship.
A personal family interest relates to the personal interests of a family member and involves a current payment to the family member. The main examples include the following:
• Any consultancy, directorship, position in or work for a healthcare industry that attracts regular or occasional payments in cash or in kind.
• Any fee-paid work commissioned by a healthcare industry which is paid in cash or in kind.
Declaration of Conflicts of Interests Form
I declare that I have read and understood the BOA’s Code of Ethics on Declarations of Interests. I hereby declare the following interests in the healthcare industry according to the BOA’s published code.
Personal Pecuniary Interest
Description (if you have no interests in this category, state ‘none’)
Personal Family Interest
Description (if you have no interests in this category, state ‘none’)
Non-personal Pecuniary Interest
Description (if you have no interests in this category, state ‘none’)
To download a copy of the form click here: Conflict of Interest Declaration.pdf
A register of conflicts of interest can be found under 'Related Content' below.
BOA Statement on Professional Engagement and the Media (with special reference to Metal on Metal)
The British Orthopaedic Association (BOA) works with many stakeholders to ensure that the highest standard of care is given to all patients needing orthopaedic treatment.
The BOA, as the body representing the orthopaedic profession, is made up of professional Orthopaedic Surgeons who are not paid for this, often time consuming, work.
Members of the BOA are often asked to advise government bodies and expert advisory groups, chairing and sitting on various committees. They do so without payment and they do this work for the greater good of orthopaedic patients. Our members accept this as a professional responsibility.
All possible conflicts of interest are disclosed and openly discussed. It is in the interests of the patients that the NHS, surgeons and industry work together to provide the best possible outcomes for patients.
We are open and transparent with the media and make ourselves available to talk constructively through the media to the public. Unfortunately, from time to time, some media stories needlessly scare patients, hamper projects that are working to protect patients and damage, by unfounded allegations, the reputations of surgeons and research groups (1) Some stories are sensationalised and at times unbalanced. These not only undermine our ability to ensure patient safety but also add to patients’ anxiety when they are most vulnerable.
We deplore irresponsible reporting. There have been examples of this with regard to the coverage of stemmed metal-on-metal hip replacement.
Metal-on-metal hip replacement has posed many challenges and the record of decisions (2,5) clearly shows that surgeons on the UK Regulator’s (the MHRA) Expert Advisory Group, who are also members of the BOA, BHS (British Hip Society) and represent us on the National Joint Registry (NJR), have not protected industry and have exercised their judgment in favour of protecting patients as new information accumulated.
The evidence for this is irrefutable on two counts:
Firstly, because of the efforts of the Expert Advisory Group, the BOA and MHRA, the UK was the first country in the world (6) to offer guidance on metal-on-metal hip replacement.(3,4) This guidance was based on data from the England and Wales National |Joint Registry (7) and from the Australian National Joint Registry (8) with whom our own NJR maintains an active dialogue. Other countries, including the United States, were unable to convert such information into action.
Secondly, members of the Expert Advisory Group, through the BOA and BHS, made public statements in 2011 (9) and 2012 (10) recommending extreme caution in performing large head metal-on-metal stemmed hip replacement. Our members have sought to influence decisions that have gone well beyond the caution the regulator has had to exercise. Our members went as far as advising a ban10 on this procedure before the recent Lancet paper (11) was published.
The BOA has full confidence in the integrity of all the members of the MHRA Expert Advisory Group giving advice on metal-on-metal joint replacement. The current Chair, Mr. John Skinner, was appointed precisely because of his outstanding knowledge, research and clinical expertise in this field. The MHRA (12) and the EAG were fully aware and specifically informed of his involvement with the London Retrieval Centre for failed implants. This retrieval centre continues to contribute to our understanding of failure of implants and to play a significant part in our quest to ensure the safety and quality of care we give our patients. (13,14) The centre has a worldwide reputation for excellence and it is funded by ABHI (Association of British Health Care Industries) who have no editorial control over or influence into the output of the centre. Naturally the findings are subjected to expert peer review in international journals. (13,15,16)
1. Dowling K. Row over adviser on metal hips. Sunday Times 2012 11/3/12.
2. DePuy ASR™ hip replacement implants. Medical Device Alert. London: Medicines and Healthcare Products Regulatory Agency (MHRA), 2010.
3. DePuy ASR™ acetabular cups used in hip resurfacing arthroplasty and total hip replacement. Medical Device Alert. London: Medicines and Healthcare Products Regulatory Agency (MHRA), 2010.
4. All metal-on-metal (MoM) hip replacements. Medical Device Alert. London: Medicines and Healthcare Products Regulatory Agency (MHRA), 2010.
5. All metal-on-metal (MoM) hip replacements. Medical Device Alert. London: Medicines and Healthcare Products Regulatory Agency (MHRA), 2012.
6. Skinner J. SOFT TISSUE NECROSIS ASSOCIATED WITH METAL ON METAL HIP IMPLANTS. Report of the MHRA-BOA Joint Working Group (MHRA-BOA). London: Expert Advisory Group, MHRA-BOA, 2009.
7. Porter M, Borroff M, Gregg PJ, Howard P, MacGregor A, Tucker K. National Joint Registry for England and Wales, 6th Annual Report 2009. London: National Joint Registry, 2009.
8. Graves SE, Davidson D, Steiger R. Hip and Knee Arthroplasty: Annual Report 2008. Adelaide: National Joint Replacement Registry, Australian Orthopaedic Association, 2008.
9. Hodgkinson J, Skinner J, Kay P. Large Diameter Metal on Metal Bearing Total Hip Replacements. London: British Orthopaedic Association and British Hip Society, 2011.
10. BHS statements on Large Diameter Metal on Metal bearing Total Hip Replacements. London: British Hip Society, 2012.
11. Smith AJ, Dieppe P, Vernon K, Porter M, Blom AW. Failure rates of stemmed metal-on-metal hip replacements: analysis of data from the National Joint Registry of England and Wales. The Lancet 2012.
12. Ludgate S. Letter to Sunday Times regarding Conflict of Interest. Sunday Times 2012 18/3/12.
13. Underwood R, Matthies A, Cann P, Skinner JA, Hart AJ. A comparison of explanted Articular Surface Replacement and Birmingham Hip Resurfacing components. J Bone Joint Surg Br 2011;93(9):1169-77.
14. Hart AJ, Hester T, Sinclair K, Powell JJ, Goodship AE, Pele L, et al. The association between metal ions from hip resurfacing and reduced T-cell counts. J Bone Joint Surg Br 2006;88(4):449-54.
15. Hart AJ, Matthies A, Henckel J, Ilo K, Skinner J, Noble PC. Understanding Why Metal-on-Metal Hip Arthroplasties Fail: A Comparison Between Patients with Well-Functioning and Revised Birmingham Hip Resurfacing Arthroplasties AAOS Exhibit Selection. J Bone Joint Surg Am 2012;94(4):e221-10.
16. Haddad FS, Thakrar RR, Hart AJ, Skinner JA, Nargol AV, Nolan JF, et al. Metal-on-metal bearings: the evidence so far. J Bone Joint Surg Br 2011;93(5):572-9.
More information about Metal on Metal can be found here: www.boa.ac.uk/PI/Pages/Metal-on-Metal.aspx