BSG Industry Interactions Policy

Scope
This policy addresses when and how we interact with industry in a range of formal and informal situations. 
 
 Formal: normally where the BSG and industry may be required to sign a contract.
 Informal: where no contract or agreement is required. 
 
 It is critical that we understand how, in the future, we present the BSG as an organisation in all industry interactions, and are consistently clear on how we position our aims, objectives, and ethical collaboration with industry.
 
 This policy should be applied proactively to activities including:  

• Conferences
• Education
• Grants
• Research
• Guidelines
• Advocacy
• Endorsement  

 
Principles
The following principles have been created to guide our interactions with industry. This expectation should be two-way and mutual. Our belief is that these principles will align our activities to the way industry has increasingly re-defined its position within the healthcare eco-system. 
 

1. The basis of the relationship between the BSG and Industry will be to support scientific and educational initiatives.
2. The BSG, members and industry should always seek to avoid any conflict between the interests of patients and where they arise should always be resolved in favour of patients.
3. BSG Members should be open and transparent at meetings, presentations and in publications as to their relationships with Industry and any potential conflicts of interest. 
4. Industry accepts that all its activities in relation to interactions with the BSG are in full respect of applicable laws, regulations, guidelines and relevant trade association codes of practice. 
5. The BSG does not accept any liability in case of non-compliance to Industry regulation or legislative healthcare requirements. 

 
 
 
Communicating the code to external partners

• The BSG cannot assume responsibility for non-compliance with industry regulations or legislation standards.
• For information and guidance on regulations and legislation involving the support of 3rd party (medical society) activities, Industry should follow the Codes of Practice issued by respective regulatory or trade organisations.
• Industry is responsible in all situations for ensuring that any product promotion at BSG activities is legal and ethical in the United Kingdom. 
• If Industry believes any of our partnership activities do not align to industry codes, they should advise their BSG contact as soon as possible.

 
Approach
Our position is that BSG activities are organised independently, with costs offset indirectly and partially by Healthcare Industry funding. Everyone working in Gastroenterology and Hepatology has a critical role to play, including, but not limited to, resources, knowledge sharing, and, most importantly, a shared mission and vision.
  
 The goal of the BSG, Medical Societies in general and Industry is to develop an evolving partnership that is trusted, connected and forward thinking. To foster trust among the general public, healthcare professionals, governments and regulators, all parties' personal interests must be stated clearly from the start. 
  
 This policy will enable the BSG to work within a consistent, ethical framework to guide us in how we shape compliant interactions with industry partners.
  
Applying Regulations and Codes
Industry is changing - with an increasing focus on ethical interactions with healthcare organisations (such as the BSG), healthcare professionals and patients. As an organisation it is important for the BSG to understand these requirements and integrate the results into our working processes and, where in line with our principles of interaction, alter our approaches in order to be aligned.
  
Applying industry codes – who is responsible?
Industry is responsible for applying and adhering to all applicable codes, laws and regulations e.g. ABPI and ABHI Codes of Practice. Industry will be held accountable by representative Industry bodies (e.g., PMCPA / ABPI in the UK) if there is a breach of industry codes of practice.
 
 However, the BSG is developing a greater understanding of these industry codes of practice and how these are applied to our interactions with industry to enable us to create interactions that are valuable to both parties and compliant with industry codes of practice.
  
Industry code of Ethics & Conduct
To ensure that we always act to the highest standards and to demonstrate our commitment to our industry partners we must consider the codes from relevant Industry bodies.
  
 We have included key statements from industry bodies visions, missions, and codes of practice to help us better understand how these may be applied to our interactions with industry.
  
 See Appendix C. 
  
Compliant Marketing Opportunities
Considerations:
 It is appropriate for industry to promote their products to healthcare professionals and other relevant decision makers within the scope of a medicines marketing authorisation. The participation in and sponsorship by Industry of 3rd party meetings such as BSG Live and other similar meetings is considered acceptable if it falls within the requirements of industry codes.
  
 Scope: sponsorship, exhibit and symposia at conferences and meetings.
  
 For the purpose of BSG planning we should consider key clauses of the codes of the UK industry bodies.
  
 

Guidance for virtual / hybrid meetings: Guidance April 2022
   
Education & Training Initiatives
Considerations: 
 Education as a goal, and Industry sponsorship or support of educational activities, is included in codes of practice. To this end significant resources are applied by medical and commercial functions in the provision of education and training of healthcare professionals. Due to the potentially positive impact on our members working with industry in these areas are key.
 

Scope:
 Smaller events, trainee focussed events, national introduction day, endoscopy training (with or without CPD accreditations)
 
 Industry code requirements:

• Industry codes apply at any time industry is involved with a meeting, financially or in kind, and the company must be recognised for its sponsorship or involvement.
• A contract will be required by industry to formalise any financial support. This should be completed well in advance of any initiative.
   

Grants; Educational, Research, Fellowships, Bursaries
Considerations:
 Some firms can be hesitant to join in these types of projects due to the perception of a purely financial relationship. Industry often calculates FMVs (Fair Market Values) in terms of these types of activity, as part of company policies, therefore they will not be able to financially support beyond these limits. In general donations are physical items, services or benefits-in-kind. Grants are the provision of funds.
 
 Items                                                                       ABPI                             ABHI
 Donations and Grants                                      Clause 23                  Chapter 4                                       
  
 Industry code requirements: 

• Donations and grants are made for the purpose of supporting healthcare, scientific research or education. These should not constitute an inducement to recommend and/or prescribe, purchase, supply, sell or administer specific medicines and are prospective in nature. Donation and grants should not bear the name of any medicine. Although, they may bear the name of the company providing them.
• There must be a written agreement in place for each donation or grant.
• Company involvement should be made clear for donations and grants to the extent possible.
• Must not be provided to individuals.
• The provision of donations or grants must be separated from product promotion. E.g., donations and grants should not be discussed at the same time as promotion
• All donations and grants to UK Healthcare Organisations must be annually disclosed via the ABPI disclosure website.   

 
Online / Digital Initiatives 
Considerations: Industry are able to sponsor initiatives in digital formats. The experience of industry in their own digital initiatives could help the BSG create effective digital programmes. The digital environment can provide significant risks for industry in promotional and scientific data being viewed by those not authorised to view it, such as members of the public and patients. Programmes with controls, developed with industry, will be required.     
  
 Scope: web education articles, podcasts 
  
 Industry code requirements:

• Industry codes apply.
• It should be made clear as to the scope of Industry support to those viewing/listening any digital content.
• A contract will be required by Industry to formalise any financial support. This should be completed well in advance of any initiative.
• The BSG runs strict sign up permission procedures which ensure that the content provided is appropriate to healthcare professionals, patients or the general public.   

 
Sustainability Projects, Career Development & Wellbeing, AI & Innovation, EDI Initiatives
Considerations:
 These types of interaction are not directly referenced within industry codes. Companies will generally take each opportunity on a case-by-case basis and consider how the initiative may align to Industry’s existing initiatives, reflect on their brand and the requirements and spirit of their codes of practice.
 
 Industry code requirements: 
 The benefits of these types of initiatives do not negate the requirements of the code. 
 
Collaborative working with Industry

1. Collaborative working:  Collaborative working which either enhances patient care or is for the benefit of patients or alternatively benefits the NHS and, as a minimum, maintains patient care is acceptable providing it is carried out in a manner compatible with the code. Collaborative working is generally between one or more pharmaceutical companies, healthcare organisations and other organisations.
2. Joint working:  Joint working between one or more pharmaceutical companies and the NHS and others which is patient centred and always benefits patients is an acceptable form of collaborative working, providing it is carried out in a manner compatible with Clause 20 and other relevant requirements of the ABPI Code. It must be clear in the documentation that the project is a joint working project and account must be taken of relevant best practice guidance on joint working between the NHS, the pharmaceutical industry and other relevant commercial organisations.  Case studies can be found here.
3. Research collaborations  

 Partnership requirements: the ABPI guide for developing effective NHS-industry partnerships can be found here.

• apply the guidelines at the earliest stage possible when planning, in-scope, collaborative activities
• comparisons between collaborative and joint working can be found in the document
• A 10-step approach is included when planning a collaborative activity   

 
Definitions

• Industry - Means any company or business, or an agent or representative thereof, that manufactures, sells, or distributes pharmaceuticals, medications, prescription drugs or medical devices.
• Healthcare Organisation (HCO) - A medical society or association is an organisation representing a particular group of medical professionals.
• (Industry) Guideline - A guideline provides general guidance and additional advice and support for policies, standards or procedures.
• Policy - A policy is a formal statement of a principle that should be followed by its intended audience.
• Codes – Rules and guidance documents agreed by members of industry bodies. Often known as Codes of Practice or Codes of Ethical Conduct directed at the promotion / marketing of medicinal products or devices to healthcare professionals, other relevant decision makers and the provision of information to the public, patients and patient organisations.
• Compliance – the process, action or result when adhering to codes of practice or policies.
• Transfers of Value – the process whereby financial payments are publicly disclosed. This can include, for example, payments between industry and healthcare professionals, healthcare organisations, patient organisations and the public.
• IFPMA web  – The International Federation of Pharmaceutical Manufacturers Association Represent research-based biopharmaceutical companies and regional and national associations across the world.
• EFPIA web - The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe.
• IPCAA web – The International Pharmaceutical Congress Advisory Association is made up of members from leading pharmaceutical and medical device companies.
• ABPI web - The Association of the British Pharmaceutical Industry is the trade association for over 120 companies in the UK producing prescription only medicines for humans.
• ABHI web – The Association of British Healthtech Industries is the UK's leading industry association for health technology (HealthTech)

 
Summary Statement
BSG takes our members' roles and relationships with industry partners seriously, and any failure to comply with the details outlined in this policy may have a negative impact on our partnerships with the larger healthcare community and the trust they have in us.
  
 
Appendix 
Appendix A - Roles and Responsibilities
    
Appendix B – FAQs
 
 Members 
 Q: Can industry support me to attend a meeting? (Context: a healthcare professional attending a meeting requiring support to any of; travel, registration, accommodation) 
  A: Medical device companies are unable to provide this type of support to healthcare professionals. Pharmaceutical companies may sponsor or support travel, accommodation, and registration expenses for UK healthcare professionals to attend meetings in the UK and abroad, either directly or through the BSG. It should be noted that the company will make this transfer of value public in the UK via search.disclosureuk.org.uk/ .
 
 Q: Given that the BSG is not an industry organisation, why does the BSG align with industry codes? 
 A: The BSG respects its industry partners' codes of conduct and makes every effort to align our arrangements and interactions with them, based on the requirements of industry regulations.
 
 Q: Do industry codes apply to BSG activities?  
 A: Industry is unable to financially support or attend BSG meetings that do not comply with their codes. If industry works with the BSG, or if they are expected to attend BSG events, the activity must comply with relevant industry codes. 
  
 Q: Can the BSG ask industry to provide hospitality during our meeting?
 A: Yes, if the hospitality is in association with scientific meetings, congresses or training which must have a clear educational content; it should be the programme that attracts delegates to attend and not the associated hospitality. Hospitality cannot be provided to an accompanying person. Any associated subsistence (food and drink), must be strictly limited to the main purpose of the activity, must be of secondary consideration and must be appropriate and not out of proportion to the occasion. Industry codes in the UK have a limit of £75 plus VAT plus tip for hospitality. Many companies have policies which set a lower limit or preclude the sponsorship of hospitality at meetings.
  
 Industry
 Q: We are a small company we don’t really understand the implications of supporting the BSG. 
  A: We communicate that we have taken the decision to align our interactions and activities to industry codes when we work together; financially or in-kind. Further, we expect our partners to follow our interactions with industry principles and all relevant laws, regulations and codes. 
  
 Q: Can we use our product logo on the materials created for an activity. (e.g., website, conference branding).  
 A: There is precise guidance within industry codes and policies on the use of product logos in the public domain. Generally, the use of company branding can be used to identify the organisation and in terms of industry’s support to BSG activities. It is likely that each company will have internal processes to approve the use of both product and company branding in all circumstances. 
  
 Q: Why does the BSG want to publicise our sponsorship to the activity?
 A: Industry codes specifically state “The declaration of (industry) sponsorship must be sufficiently prominent to ensure that readers are aware of it at the outset.” 
  
 Q: Is the activity (e.g. conference) approved? 
 A: This relates to the vetting by industry bodies of 3rd party (medical society) meetings that fulfil a specific scope which can be found here Note. Some of the requirements for Medical Device and Pharmaceutical companies can differ.
 
 Q: Why can Industry not sign our contracts? (Context example: a meeting sponsorship agreement) 
 A: Industry codes expect formal agreements to be in place where there are any Transfers of Value between industry, healthcare professionals or healthcare organisations (the BSG). Due to this requirement many industry organisations have internal processes that do not allow any other agreements reflecting this relationship to take precedence over their templates.    
  
 Q: Can I attend the meeting? (Context: industry representatives from the medical and commercial disciplines) 
 A: Industry takes significant steps to separate their commercial and medical disciplines. In this case we encourage industry medical professionals to join relevant activities e.g. selected scientific sessions.

Appendix C: Trade Bodies (regulators) for the Pharmaceutical & Medical Device Industries
 
i. International

• IFPMA Code of Practice
   “Our Code of Practice was first drawn up in 1981, and it was the first one of its kind for any sector. Initially, correct information on the effects and side effects of medicines were at the core of the Code. Today, through periodic updates, expectations regarding compliance are much more comprehensive. Updated and revised over the decades, the Code sets out a rules-based compliance framework for clinical research, fees for services, support for continuing medical education, to name but a few. Many local and regional associations rely on the IFPMA Code as guidance for their own codes of conduct. The last Code revision in 2012 saw its scope expanded beyond marketing practices to cover all interactions with healthcare professionals, medical institutions and patient organizations.

 ii. European Region

• EFPIA (Pharmaceutical) Code of Practice 
   “The EFPIA Code constitutes the collection of ethical rules agreed by EFPIA members for the Promotion of Medicinal Products to healthcare professionals (HCPs) and the interactions with HCPs, healthcare organisations (HCOs) and patients' organisations (POs), with the intent of guaranteeing that these activities are conducted while respecting the most stringent ethical principles of professionalism and responsibility.”

 

• MedTech Europe (Medical Devices) - Code of Ethical Business Practice
   “The Principle of Separation: Interaction between industry and Healthcare Professionals/ Healthcare Organisations must not be misused to influence through undue or improper advantages, purchasing decisions, nor should such interaction be contingent upon sales transactions or use or recommendation of Member Companies’ products.”

 
iii. UK
 In this section we highlight some key points regarding the way these bodies present how meetings, sponsored by industry, should be planned.

• ABPI Code of Practice 
   “Pharmaceutical companies may hold, sponsor or support delegates to attend a wide range of events/ meetings, providing such events/meetings meet the requirements of the Code. The event/meeting must have a clear educational content; it should be the programme that attracts delegates to attend and not the associated hospitality or venue.”
   Relevant clauses: 10, 28

 

• ABHI Code of Ethical Business Practice  
   “A member company shall not organise events which include social, sporting and/or leisure activities or other forms of entertainment, nor support such elements where part of third party Organised Educational Events (such as a medical society congress).”

 
Clauses: chapter 1-4
  
Appendix D - Industry code requirements

 These requirements are correct at the type of writing but are subject to change from time to time.
  

• Pharmaceutical companies may hold, sponsor or support delegates to attend a wide range of events/meetings, providing such events/meetings meet the requirements of the Code. This may include support of health professionals not known to the company via a healthcare organisation by way of registration fees, accommodation and travel.
• The event/meeting must have a clear educational content:
• it should be the programme that attracts delegates to attend and not the associated hospitality or venue
• the content must be appropriate and relevant to attendees
• the venue must be appropriate and conducive to the main purpose of the event/meeting; lavish, extravagant or deluxe venues must not be used
• any associated subsistence (food and drink), accommodation and travel costs must be strictly limited to the main purpose of the event/meeting, must be of secondary consideration and must be appropriate and not out of proportion to the occasion
• companies must not sponsor, support or organise entertainment (such as sporting or leisure activities, etc)
• any hospitality provided must not extend to an accompanying person unless that person qualifies as a proper delegate or participant at the meeting in their own right. In exceptional cases of established clear health needs of the delegate (e.g., disability or injury), similar hospitality may be provided for an accompanying person.
• No payment may be offered or paid to individuals to compensate merely for the time spent in attending events/meetings.
• Pens/pencils and notepads provided in conference bags at independently organised meetings must not include the name of the donor company, the name of any medicine or any information about medicines.
• The total cost to the donor company of all such items provided to an individual attending an event/meeting must not exceed £6, excluding VAT. The perceived value to the recipient must be similar.
• Pens/pencils and notepads must not be given out from exhibition stands.
• Quizzes which are intended to gauge attendees' understanding of the subject matter of a meeting are acceptable provided that such quizzes are non-promotional and genuine tests of skill or knowledge; they must respect the professional standing or otherwise of the audience and no prizes can be offered. To be acceptable, a quiz must form part of the meeting's formal proceedings. Quizzes must not be conducted from or on exhibition stands.
• The use of competitions, quizzes and suchlike are unacceptable methods of promotion
• The cost of any subsistence (food and drink) provided must not exceed £75 per person, excluding VAT and gratuities per meal.
• When events/meetings are sponsored by pharmaceutical companies, that fact must be disclosed in all the material relating to the events/meetings and in any published proceedings. The declaration of sponsorship must be sufficiently prominent to ensure that readers are aware of it at the outset.
• Companies should only offer or provide economy air travel to delegates attending events/meetings.
• No company may require that it be the sole funder or sponsor of a healthcare organisation or patient organisation or any of its programmes.
• Companies must document and publicly disclose annually financial details of support of, and certain transfers of value made directly or indirectly to health professionals, other relevant decision makers and healthcare organisations located in Europe. This includes any employee of a pharmaceutical company whose primary occupation is that of a practising health professional.
• The transfers of value covered by Clause 28.1 and 28.2 are:
  1. donations and grants provided to healthcare organisations, institutions and other organisations in accordance with Clause 23
  2. fees and expenses paid for contracted services between companies and institutions, organisations or associations of health professionals, in accordance with Clause 24.6
  3. support of attendance by health professionals and other relevant decision makers at events/meetings whether paid directly, indirectly or via another party in accordance with Clause 10.11
  4. sponsorship, including contributions to costs related to events/meetings paid to healthcare organisations or to organisations managing events on their behalf, which may include support of health professionals not known to the company via the healthcare organisation by way of registration fees, accommodation and travel, in accordance with Clause 10.12