Working with the Pharmaceutical Industry

Version 1.1 December 2016

Working with the Pharmaceutical Industry

Target Audience

Who Should Read This Policy

Health Care Professionals

Clinical Staff


Version 1.1 December 2016 2

Ref. Contents Page

1.0 Introduction 4

2.0 Purpose 4

3.0 Objectives 4

4.0 Process 4

4.1 Code of Conduct 4

4.2 Declarations of Interest 5

4.3 Collaborative Working 6

4.4 Hospitality and Educational Meetings/ Support 6

4.5 Individual Meetings with Representatives 7

4.7 Contracts 8

4.8 Training Events 8

4.9 Sponsorship of Health-Professional Posts 9

4.10 Research and Development 9

4.11 Purchasing Decisions 10

4.12 Charitable Funding 10

5.0 Procedures connected to this Policy 10

6.0 Links to Relevant Legislation 10

6.1 Links to Relevant National Standards 11

6.2 Links to other Key Policies 12

6.3 References 12

7.0 Roles and Responsibilities for this Policy 14

8.0 Training 14

9.0 Equality Impact Assessment 15

10.0 Data Protection and Freedom of Information 15

11.0 Monitoring this Policy is Working in Practice 15

Appendices

1.0 Potential Gains for Both Parties 16

2.0 Values and Definitions 17

3.0 Examples of Potential Conflict 18

4.0 Extract From the Medicines (Advertising) Regulations 1994 19

5.0 Research and Development 20



Explanation of terms used in this policy

Commercial Sponsorship - NHS funding from an external source to include funding of all or part of

the cost of:

Staff

NHS research

Training

Pharmaceuticals (Medicines and products)

Equipment

Meeting rooms

Costs associated with meetings

Meals

Gifts

Hospitality

Hotel and transport costs (including trips abroad)

Provision of free services (e.g. speakers)

Buildings or premises

Medicine - Any branded or unbranded medicine intended for use in humans which requires a

marketing authorisation

Product - Any dressing or appliance included in the Drug Tariff

Health professional - A member of the medical, pharmacy, nursing or allied health professions or

any other person/s who, in the course of their professional activities, may prescribe, supply or

administer a medicine or product

Representative - A representative from the pharmaceutical industry calling on members of the

health professions and administrative staff in relation to the promotion of medicines or products

Procedural Documents - The collective term for policies, procedures or guidelines

Policy - sets out the aims and principles under which services, divisions, or units will operate. A policy

outlines roles and responsibilities, defines the scope of the subject covered, and provides a high level

description of the controls that must be in place to ensure compliance



1.0 Introduction

The New NHS: Modern and Dependable places an obligation on NHS Trusts to work

together and in collaboration with other agencies to improve the health of the population served. Recent changes in the National Health Service have led to many

more people undertaking roles in which they come into regular contact with the pharmaceutical industry. The involvement of front-line staff, as well as some senior (mostly clinical) personnel, on boards and subcommittees of the Trust means that

some of these individuals may be approached by representatives of the pharmaceutical industry wishing to discuss a wide range of subjects.

Collaborative working with the pharmaceutical industry can have a number of benefits, including provision of information about products and therapeutic issues, educational

activities, project support, provision of resources/materials/ equipment or expertise. Additionally the industry has financial resources that can be deployed to sponsor

activities that benefit the patients and the NHS. These resources however need to be harnessed with care and a transparent approach is needed to any sponsorship agreement.

This guidance is offered to all Health Professionals and other Staff who work in the

Trust to help them apply the principles of the DH Code of Practice (Commercial Sponsorship – Ethical Standards for the NHS, DoH, November 2000.

The guidance is mandatory for health professionals and staff employed by the Trust.

Some activities sponsored by Pharmaceutical Companies may directly compete with the CCG’s efforts to encourage quality and cost-effective prescribing. Staff working within the Trust should be aware of this before entering into any arrangements with a

pharmaceutical company that may impact on the health economy.

2.0 Purpose

The purpose of this policy is:

To protect healthcare professionals and clinical staff who work within the Trust

To improve the health of patients by maximising available resources within an ethical framework

3.0 Objectives

To ensure that health professionals and clinical staff who work with the

pharmaceutical industry are aware of their responsibilities

To provide a framework for working with the pharmaceutical industry 4.0 Process

4.1 Code of Conduct

This policy is in addition to personal and professional standards required by

professional Codes of Conduct such as those issued by GMC, RPS, GPhC, NMC etc.

Trust staff are expected to:

Act impartially in all their work

Refuse gifts, benefits, hospitality or sponsorship of any kind which might reasonably be seen to compromise personal judgement or integrity, or seek to exert influence to obtain preferential consideration. Note that all NHS staff fall

under the ambit of the Bribery Act 2010, which places a particular emphasis on



declaring any offers of gifts, hospitality or sponsorship, regardless of whether or not they are accepted

Declare and record any financial or personal interest (e.g. company shares, research grant) in any pharmaceutical company or organisation with which they

have to deal, and be prepared to withdraw from those dealings if required, thereby ensuring that their professional judgement is not influenced by such considerations

Beware of bias generated through sponsorship, where this might impinge on

professional judgement and impartiality

Not to practice under any conditions that compromise professional independence

or judgement, nor impose such conditions on other professionals

Refuse the provision of lavish hospitality whether or not related to an education

event

Ensure professional registration (if applicable) and /or status are not used in the

promotion of commercial products or services

Note that:

Personal gifts of any description are no longer acceptable, except for writing materials at conferences and meetings for the purpose of the meeting. Such

materials must be of low promotional value; i.e. something that has cost the drug company no more than £6 excluding VAT

Provision of medical, educational services or materials intended for patients that

enhance patient care or NHS services is acceptable Breach of the Code by a practitioner may be offered as evidence that a practitioner has not abided by the code of conduct that applies to the profession

to which that person belongs. Any suspected breach of the Code of Conduct by a member of the

pharmaceutical industry should be reported to the Medical Director or Chief Pharmacist.

4.2 Declarations of Interest

1. The Trust should maintain a register containing declarations of interests for core

MMC members. This register will be managed by the Chair of MMC 2. Any non-core MMC members presenting or discussing specific drug applications

or positioning decisions (at MMC) should complete a declaration of interest form

3. This registers and declarations of interest should be open to public scrutiny if required

4. Interests which should be registered include:

Financial or personal interest in any organisation with which they or their

families have, and with which they deal. They should be prepared to withdraw from those dealings if required to demonstrate that their professional judgement is not influenced by commercial considerations

The review of therapy and/or product switching by staff employed by a third party which has been commissioned on behalf of the Trust by a pharmaceutical

company

Provision of hospitality related to an education event funded to a level in

proportion to the occasion

Supply and on-going service of medical equipment such as blood glucose monitors, blood pressure monitoring equipment etc.



Trust Board members, MMC members, all prescribers, and pharmacists will be required to make annual declarations of interest.

4.3 Collaborative Working

It is mandatory for employed staff to inform the MMC about any projects arranged with a pharmaceutical company.

No promotional product-specific message must be contained in any patient information leaflets handed out as part of a project.

Practitioners must make sure that patients taking part in a project know that they have the right to choose to participate (Please refer to Research Policies and SOPs).

Where products or initiatives are in areas where more than one company has an

interest, these projects should ideally involve more than one sponsor. Official co-partnership arrangements, including a tendering process for patient programmes, should be considered where appropriate.

Potential partners shall not advertise or imply that the participation of the Trust is an

endorsement of their products, packages or company without the explicit written permission of the Trust.

Patient information is confidential. Practitioners must not allow pharmaceutical company representatives to have access to patient records.

Clinical teams should not permit people representing or employed (directly or indirectly) by pharmaceutical companies to have access to the Trust’s computers, or to

download, transmit or otherwise have access to patient information. In particular, practitioners should not allow programmes for data extraction to be loaded on to

computer systems without prior consent from the Medical Director and IT. Any public or patient facing materials to be used in the Trust (e.g. posters, or patient

information leaflets, etc.) which are supplied by pharmaceutical industry or their representatives should be carefully assessed. This is assessment (normally by

pharmacy staff) is for value, reliability, relevance, balance and bias, information content including potential risks and patient choice.

[The DISCERN Instrument – www.discern.org.uk is helpful in this regard]. Some sponsored activities may directly compete with CCG initiatives to encourage quality and cost-effective prescribing across the Black Country health economy. Trust employees should be aware of this before entering into

any arrangements with a pharmaceutical company.

4.4 Hospitality and Educational Meetings/ Support

Before sponsorship is sought for hospitality or a training event, consider whether the event could be arranged without sponsorship or whether alternatives to sponsorship

might be more appropriate.

Obligations relating to the provision of inducements and hospitality are placed on the

pharmaceutical industry and health professionals by the Medicines (Advertising) Regulations:

http://www.discern.org.uk/



1. Industry representatives organising meetings are permitted to provide appropriate hospitality and/or meet any reasonable, actual costs, which may

have been incurred 2. The level of hospitality offered must be in proportion to the occasion, not

exceeding that which recipients would normally pay for themselves or expect to be reciprocated by the NHS

3. A decision to attend meetings organised or sponsored by the pharmaceutical

industry, in the UK or at venues outside the UK, should be based on the programme and not the associated hospitality or venue

4. Where meetings are sponsored by the pharmaceutical industry this fact must be disclosed in the papers relating to the meeting and in any published proceedings

5. The Trust reserves the right to exclude any sponsor from the content of the

meeting 6. Payments may not be made to prescribers or groups of prescribers, either

directly or indirectly, for rental of rooms to be used for meetings All sponsored educational events for health professionals held within the Trust,

whether members of the public are included or not, should include a Trust consultant psychiatrist, nurse or pharmacist in the planning process.

This person must ensure that:

Safe practices are used regarding the provision of samples and healthcare

equipment

Display stands used by the representatives, or any information with product

names or information, are not visible during speaker sessions

Members of the public do not have access to these products unless they are

specifically for use by the public

At the end of the event, no samples, healthcare equipment or promotional materials are left behind to which the public might obtain access

4.4.1 Basic Principles of Meeting/ Support

The meeting must have a clear educational content

Hospitality must be secondary to the purpose of the meeting

Hospitality must be appropriate and not out of proportion to the occasion

Hospitality must not extend to a spouse, partner or other such person unless that

person is a member of the health professions or appropriate administrative staff and qualifies as a proper delegate or participant in their own right

Spouses and other accompanying persons, unless qualified as above, may not

attend the actual meeting and may not receive any associated hospitality at the company’s expense. Their entire costs are the responsibility of those they

accompany

Any speakers who are sponsored by a company must declare their interest

before speaking

All companies must be publicly thanked during the meeting for their contribution to the event

All hospitality must be logged in the hospitality register. This may be open to scrutiny

4.5 Individual Meetings with Representatives

Staff must not ask for, or accept fees or material gifts for agreeing to meet with

representatives of the pharmaceutical industry.



Ideally, meetings should:

Be pre-booked

Have a stated purpose

Last an agreed length of time

Have agreed participants

4.6 Provision of Free Medication Samples

Samples:

Are not permitted to be accepted by a member of the Trust

Should not be requested by a member of the Trust

Any exceptions to this must be with the express authorisation of the chief

pharmacist

4.7 Contracts

Patient information attracts a legal duty of confidentiality and is treated with particular

sensitivity under Data Protection legislation. It is extremely important therefore that individuals signing contracts assure themselves, taking advice where necessary from the Trust’s Caldicott Guardian, that sponsorship agreements are both lawful and meet

the appropriate ethical standards.

Any individual signing these contracts on behalf of the Trust must ensure that a risk assessment has been carried out prior to any proposed agreement with an external third party. Any contract must also ensure that details of any security controls,

responsibilities, liabilities, reviews and amendments are included within it. In particular these details must draw attention to the obligations of confidentiality and specify

security standards that should be applied. The contract must also limit the use of the information to the purpose specified in the contract, and make it clear that the contract will be terminated if these conditions are not met.

The contract should make clear that funding will only be accepted when a detailed written agreement has been accepted and signed by both sides. This would include:

Contact names on both sides

Expected outcomes and outputs

Monitoring and enforcement of the agreement and provision of progress reports

An opt-out clause for both parties 4.8 Training Events

4.8.1 Sponsored Education/ Training Events

Must have a clear educational content which is defined before the meeting

Must have an agenda/ programme

Must identify the names of the sponsoring companies at the event/ meeting

Must not have the primary focus on a drug or drugs marketed by the sponsoring company or companies without making reference to the CCG or Trust Formulary

and the positioning of that drug in the Formulary. The organiser of the meeting must declare at the meeting if drugs that will be

discussed during the meeting are not included in the Formulary

Employers should be careful to ensure that staff are not pressurised by sponsors of

training, to alter their own activity in accordance with the sponsor's wishes, when this is not backed up by the appropriate evidence.



Participants should ensure that any suggested change in practice is supported by

appropriate evidence, and that they are not unduly influenced by the sponsors. The Trust should only accept pharmaceutical company sponsorship for professional

training if it can be assured that such training is in line with Trust policy and has been identified through a training needs assessment.

4.9 Sponsorship of Health-Professional Posts

The post-holder must be informed that the post is subject to sponsorship and the

name of the sponsor. Request for information by the sponsor must be made directly to the Trust and not to

the post-holder. Responsibility for collation and disclosure must not involve the post-holder.

Sponsorship should not be accepted if it would require a health-professional to recommend the sponsor's product in preference to other clinically appropriate

products, or if it requires the patients to use a particular service. Health-professionals should not withhold information about other products.

Always consider these key points:

Always ask the question “Are you willing to have these arrangements generally

known?”

Ensure all sponsorship is recorded in a register

Refuse sponsorship of any kind that might reasonably be seen to compromise personal, professional or corporate judgement or integrity

Ensure decision-making process is transparent and defensible

With major collaborative projects, ensure written contracts are in place

Ensure that patient confidentiality is respected in all situations 4.10 Research and Development

Well-planned and well-managed scientific research is of benefit to the Trust and the Health Economy. However, researchers should be aware that research funded by

pharmaceutical companies is more likely to have outcomes favouring the sponsor’s products than research funded by other sources (BMJ 2003).

Sponsorship from pharmaceutical companies must not influence research activities that are undertaken by an individual or group of individuals. Any support from

pharmaceutical companies should be declared as part of the ethics approval process. All research protocols (commercial and non-commercial) must be approved by the

Trust’s Research and Innovation Group.

Health professionals involved in sponsored research should have no financial interest in this, nor should patients under their care. They should not advertise the availability of their own or colleagues’ patients for use as research subjects (The Royal College of

Physicians guidance). Results of sponsored studies may be published in a journal of the health professional’s choice but should acknowledge the support of the sponsoring

healthcare company. The company should not seek to influence the results of the study.



Medical staff should follow the guidance (Research: The role and responsibilities of doctors) issued by the General Medical Council. See also Trust policies.

Pharmaceutical companies must not be given access to unpublished research findings

or audit results unless this has previously been agreed as part of research governance processes. See Appendix 5 for additional detail.

4.11 Purchasing Decisions

Purchasing decisions, including those concerning pharmaceuticals and appliances, should always be taken on the basis of best clinical practice and value for money.

Such decisions should take into account their impact on other parts of the health care system, for example, products dispensed in hospital which are likely to be required by

patients regularly at home. When making purchasing decisions on products which originate from NHS intellectual

property, ethical standards must ensure that the standard is based on the best clinical practice and not on whether royalties will accrue to an NHS body. If there is competition in the market place, a tendering process shall be undertaken as defined by the standing financial instructions of the Trust.

4.12 Charitable Funding

Trustees should take steps to remove any non-charitable items within charitable trust fund accounts. Examples include drug trials undertaken directly by a consultant and supported by funding from non-official sources (i.e. not part of the Research and

Development programme managed by the provider). Not all consultant drug trials are non-charitable (see NHS Charitable Funds: A Guide, published by the Charity

Commission), but, where they do not have charitable status, they should be removed from the charitable trust fund accounts. If the drug trial contract is made between industry and the Trust, then the transaction should be recorded as a normal income

generation scheme. In other cases, the Trust should consider other options including the transfer of responsibility back to the consultant concerned. 5.0 Procedures connected to this Policy

There are currently no Standard Operating Procedures connected to this policy.

6.0 Links to Relevant Legislation

Public Contracts Regulations 2015

The Public Contracts Regulations 2015, which implement domestically the EU Public

Procurement Directive, came into force on 26 February 2015. The Regulations are of great importance for all NHS organisations which will have to comply with them when

purchasing goods and services. The Regulations bring important changes which will help NHS bodies to buy more

smartly and efficiently. In particular, they will broaden the possibilities for NHS bodies to conduct negotiations with bidders during the procurement process, in addition to

clarifying how to conduct market consultation prior to the launch of the tender. These changes will help NHS bodies to buy products and services better adapted to their needs and to achieve better commercial outcomes.

http://www.legislation.gov.uk/uksi/2015/102/contents/made



Bribery Act 2010

The Act creates a new offence under section 7 which can be committed by commercial organisations1 which fail to prevent persons associated with them from committing

bribery on their behalf. It is a full defence for an organisation to prove that despite a particular case of bribery it nevertheless had adequate procedures in place to prevent persons associated with it from bribing. Section 9 of the Act requires the Secretary of

State to publish guidance about procedures which commercial organisations can put in place to prevent persons associated with them from bribing. This document sets out

that guidance. Medicines (Advertising) Regulations 2012

Part 14 of these regulations (Advertising) Implements Title 8 of Directive 2001/83/EC and consolidates the Medicines (Advertising) Regulations 1994 (SI 1994/1932) and

the Medicines (Monitoring of Advertising) Regulations 1994 (SI 1994/1933). It contains a variety of prohibitions on advertising, including those relating to unlicensed medicines, prescription medicines, recommendations by scientists, and

advertisements aimed at children. In addition, it sets out the information that needs to be included in advertisements and establishes rules for sampling, the promotion of

medicinal products by medical sale representatives, and hospitality at meetings. It also contains a chapter called ‘Monitoring of Advertising’, which creates a process by which Ministers can determine whether an advertisement breaches these requirements, and

in certain circumstances require that corrective action is taken. Finally, it requires Ministers to consider complaints about advertisements and permits Ministers to apply

to a court for an injunction prohibiting a particular advertisement. See Appendix 4 for further details.

6.1 Links to Relevant National Standards

MHRA Guidance – Advertising and Promoting Medicines (Blue Guide)

This guidance introduces the provisions and requirements laid down in the legislation

on medicines advertising in the UK and provide background information on the development of the Blue Guide. It also provides a general introduction to the regulation

of medicines in the UK. ABPI Guidance - Code of Practice for the Pharmaceutical Industry 2016

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. GMC Guidance - Financial and commercial arrangements and conflicts of

interest (2013)

This guidance explains how the principles in Good medical practice apply for doctors when considering their responsibilities in financial and commercial arrangements and

conflicts of interest. It develops the duties and principles set out in Good medical practice and other explanatory guidance. Doctors must follow all our guidance: serious

or persistent failure to do so will put their registration at risk.

https://www.gov.uk/government/publications/blue-guide-advertising-and-promoting-medicines

http://www.abpi.org.uk/our-work/library/guidelines/Documents/code_of_practice_2016.pdf

http://www.gmc-uk.org/guidance/ethical_guidance/21161.asp

http://www.gmc-uk.org/guidance/ethical_guidance/21161.asp



The Prescription Medicines Code of Practice Authority (PMCPA)

The Prescription Medicines Code of Practice Authority (PMCPA) was established by

The Association of the British Pharmaceutical Industry (ABPI) to operate the ABPI Code of Practice for the Pharmaceutical Industry, independently of the ABPI.

The ABPI Code covers the promotion of medicines for prescribing to health professionals and other relevant decision makers. The Code also sets standards for

information made available to the public about prescription only medicine. Advertising or promoting prescription only medicines to the public is prohibited under the ABPI

Code and the UK law. 6.2 Links to other Key Policies

Identifying Potential Participants for Research Studies Policy

The purpose of this policy is to ensure that a systematic and structured approach is taken by approved researchers when identifying potential participants for research studies.

Anti-Fraud, Bribery and Corruption Policy

The aim of this policy is to set out clearly for staff, the framework and controls in place for dealing with all forms of detected or suspected fraud, bribery and corruption.

Standards of Business Conduct Policy

The purpose of this policy is to ensure exemplary standards of conduct are adhered to

by all employees of the Trust and that staff are aware of their individual responsibilities to maintain strict ethical standards in the conduct of NHS business.

Standing Financial Instructions

These Standing Financial Instructions detail the financial responsibilities, policies and

procedures adopted by the Trust. They are designed to ensure that the Trust's financial transactions are carried out in accordance with the law and with Government policy in order to achieve probity, accuracy, economy, efficiency and effectiveness. 6.3 References

Department of Health. The new NHS: Modern and dependable. Cm 3807. London: Stationery Office; 1997

Commercial Sponsorship: Ethical standards for the NHS (2000)

The Medicines (Advertising) Regulations 1994(SI 1994 No 1932)

General Medical Council. Research: The role and responsibilities of doctors. The

Council: 2002

Royal Pharmaceutical Society’s Guidance for Pharmacists (on working with the

pharmaceutical industry); 2000

Association of the British Pharmaceutical Industry. Code of Practice for the

Pharmaceutical Industry. London:; PMCPA 2014, 2016

Prescription Medicines Code of Practice Authority (PMCPA) – ABPI; 1993

Nursing and Midwifery Council. The NMC code of professional conduct:

Standards for conduct, performance and ethics. NMC 2008, updated 2014, London.

The protection and use of patient information. HSG (96)18. Leeds: NHS Executive; 1996.

Corporate governance in the NHS: code of conduct; code of accountability. London: Department of Health; 1994

http://www.pmcpa.org.uk/Pages/default.aspx



Standards of Business Conduct for NHS Staff (HSG(93)5)

NHS Charitable Funds: A Guide – published by the Charity Commission

Report from the Royal College of Physicians (RCP) “The relationship between physicians and the biomedical industries”, Bennett J & Collins J, Clinical

Medicine 2002 2:320-322.

BMJ issue 7400: “Time to untangle doctors from drug companies” various articles

(May 2003)



7.0 Roles and Responsibilities for this Policy

Title Role Key Responsibilities

All Healthcare

Professionals

Adherence - Comply with this policy

- Ensure any training required is attended and kept up to date

- Ensure any competencies required are maintained

- Cooperate with the development and implementation of policies as part of their normal duties and responsibilities

- Identify the need for a change in policy as a result of becoming aware of changes in practice, changes to statutory

requirements, revised professional or clinical standards and local/national directives, and advising their line manager

accordingly

- Identify training needs in respect of policies

Ward Managers/ Team

Leaders

Operational - Bring to the attention of their staff the publication of this document

- Ensure that the document has been cascaded within their team or department

- Ensure this document is effectively implemented

- Ensure that staff have the knowledge and skills to implement the policy and provide training where gaps are identified

Service Managers Implementation - Implement this policy into practice within their service areas and take appropriate action should any breach of this policy

arise

Medicines Management

Committee chair

Responsible - Compile Declarations of interest form MMC annually

- Review MMC Declarations of interest Annually

Chief Executive Accountable - Ensure the provision of high quality, safe and effective services within the Trust

8.0 Training

What aspect(s)

of this policy will require staff

training?

Which staff groups require this training?

Is this training covered in the Trust’s Mandatory and Risk Management Training Needs

Analysis document?

If no, how will the training be delivered?

Who will deliver the training?

How often will staff require training

Who will ensure and monitor that staff have this training?

No training

necessary for this

policy, further

advice can be

sought from the

pharmacy team if

necessary

n/a n/a n/a n/a n/a n/a



9.0 Equality Impact Assessment

Black Country Partnership NHS Foundation Trust is committed to ensuring that the way we provide services and the way we recruit and treat staff reflects individual needs, promotes equality and does not discriminate unfairly against any particular individual or group. The Equality Impact Assessment for this policy has been completed and is readily available on the Intranet. If you require this in a different fo rmat e.g. larger print,

Braille, different languages or audio tape, please contact the Equali ty & Diversity Team on Ext. 8067 or email [email protected] 10.0 Data Protection and Freedom of Information

This statement reflects legal requirements incorporated within the Data Protection Act and Freedom of Information Act that apply to staff who work within the public sector. All staff have a responsibility to ensure that they do not disclose information about the Trust’s activities in respect of service

users in its care to unauthorised individuals. This responsibility applies whether you are currently employed or after your employment ends and in certain aspects of your personal life e.g. use of social networking sites etc. The Trust seeks to ensure a high level of transparency in all its business

activities but reserves the right not to disclose information where relevant legislation applies. 11.0 Monitoring this Policy is Working in Practice

What key elements will be

monitored? (measurable policy objectives)

Where

described in policy?

How will they be

monitored? (method + sample size)

Who will

undertake this monitoring?

How Frequently?

Group/Committee

that will receive and review results

Group/Committee

to ensure actions are completed

Evidence

this has happened

Annual Declarations of

Interest of Medicines

Management Committee

(MMC) Members

4.2 Declarations

of Interest

Completed Declaration

of Interest Form

collated with MMC

Members

Chair of MMC Annually Medicines

Management

Committee

Medicines

Management

Committee

Minutes of

meeting



Appendix 1

Potential Gains for Both Parties

For the Trust

This list includes skills and expertise in:

Project management and planning

Change management

Marketing

Health economics

Training and development

Team building and development

Data gathering, analysis and interpretation

The industry can also provide:

Shared care guidelines for use of their medicines

Updates on their product range and early information on new medicines for budget planning processes

Literature searches

Sponsorship of NHS training

Financial support for specialist health professional posts For the Pharmaceutical Industry:

Greater understanding of the way the NHS works including:

Spheres of influence Financial controls

Accountability Policy/strategy

Development of good working relationships with NHS colleagues

Improved understanding of patient care from those directly involved

Improved access to primary care

In the longer term, increased sales and therefore profits from products which have been properly tested and evaluated and proved to be effective



Appendix 2

Values and Definitions

There are three crucial public service values which underpin the work of the health service (Code of Conduct for NHS Boards (Authorities and Trusts) 1994): 1. Accountability

Everything done by those who work for the NHS must be able to stand the test of

parliamentary scrutiny, public judgements of propriety and professional codes of conduct 2. Probity (Honesty and Integrity)

There should be an absolute standard of honesty in dealing with the assets of the NHS; integrity should be the hallmark of all personal conduct in decisions affecting patients, staff and suppliers, and in the use of information acquired in the course of

NHS duties 3. Openness

There should be sufficient transparency about NHS activities to promote confidence

between the NHS Authority or Trust and its staff, patients and the public.

These are four of the Seven Principles of Public Life as defined by the Nolan Committee. The other 3 are:

Selflessness

Leadership

Objectivity

Ref: First Report of the Committee on Standards in Public Life, Cm. 2850-1, 1995



Appendix 3

Examples of Potential Conflict

It may be helpful to give some examples of the sorts of situation you could encounter

and how they could be dealt with. These are given below:

1) Offer from a company to provide for training of staff

The Trust should be careful to ensure that staff are not pressurised by sponsors of training, to alter their own activity to accord with sponsors' wishes,

where these are not backed up by appropriate evidence. Training provided by industry may be above board if it is unbiased and has mutual benefit for both the Trust and the sponsoring company, is evidence based and the hospitality

is appropriate. However participants should assess whether they may be influenced unduly and also bear in mind what benefits the company might

derive (e.g. exposure to NHS, professional contacts, potential allies to use later, names of who to influence, often without the participants realising).

2) A manufacturer of specialist equipment or medicinal product offers to

sponsor a nurse post in the Trust

The Trust should not accept the sponsorship if it would require the nurse to recommend the sponsor's in preference to other clinically appropriate appliances, nor if it requires the Trust to recommend patients to use a

particular dispensing service or withhold information about other products.

3) A manufacturer of a particular type of Nicotine Replacement Therapy offers to provide their product at a reduced rate within the Trust This arrangement is acceptable provided that there is a clear clinical view

that these products are appropriate to particular patients and there is no

obligation to also prescribe these products to other patients for whom an

alternative product would be at least as beneficial.

4) A pharmaceutical company offers to provide starter packs at a

discounted price

This type of sponsorship is acceptable, but should always be declared in order

to avoid any suspicion that subsequent prescribing might be inappropriate and linked to the provision of starter packs.

5) High tech home health care provider offers to supply equipment at

reduced rate in return for business linked to a specific product

The Trust commissioning team shall advise the company that any contract will not prejudice the provision of the most appropriate service to patients, and will not bear any relation to other contracts.

6) A manufacturer offers to pay the travelling costs or accommodation

costs for clinicians invited to a conference to view medical products

Only clinicians with a specific interest in the products should attend and the travel costs incurred should be paid for by the Trust, unless the Chief

Executive or Director of Finance and Performance gives approval for the potential supplier to take responsibility for the costs. Such decisions should be

taken at least to Director of Finance level. Reference: Commercial Sponsorship – Ethical Standards for the NHS, DoH, November 2000



Appendix 4

Extract From the Medicines (Advertising) Regulations 1994

Inducements and Hospitality

(1) Subject to paragraphs (2) and (4), where relevant medicinal products are being

promoted to persons qualified to prescribe or supply relevant medicinal

products, no person shall supply, offer or promise to such persons any gift, pecuniary advantage or benefit in kind, unless it is inexpensive and relevant to

the practice of medicine or pharmacy. (2) The provisions of paragraph (1) shall not prevent any person offering hospitality

(including the payment of travelling or accommodation expenses) at events for purely professional or scientific purposes to persons qualified to prescribe or

supply relevant medicinal products, provided that:

such hospitality is at a reasonable level;

it is subordinate to the main scientific objective of the meeting; and

it is offered only to health professionals

(3) Subject to paragraph (4), no person shall offer hospitality (including the payment of travelling or accommodation expenses) at a meeting or event held

for the promotion of relevant medicinal products unless:

such hospitality is reasonable in level;

it is subordinate to the main purpose of the meeting or event; and

the person to whom it is offered is a health professional

(4) Nothing in this regulation shall affect measures or trade practices relating to prices, margins or discounts which were in existence on 1st January 1993.

(5) No person qualified to prescribe or supply relevant medicinal products shall

solicit or accept any gift, pecuniary advantage, benefit in kind, hospitality or

sponsorship prohibited by this regulation.

Reference: Commercial Sponsorship – Ethical Standards for the NHS, DoH, November 2000



Appendix 5

Research and Development

(1) Exceptionally, in the case of non-commercial research and development (R&D)

originated or hosted by NHS providers, commercial sponsorship may be linked to the purchase of particular products, or to supply from particular sources. This should be in accordance with the guidance at paragraph 28 of HSG(97)32

Responsibilities for meeting Patient Care Costs Associated with Research and Development in the NHS.1 Where there is industry collaboration in such

studies, companies may alternatively make a contribution towards the study’s costs, rather than supply of product.

(2) Any funding for research purposes should be transparent. There should be no incentive to prescribe more of any particular treatment or product other than in

accordance with the peer reviewed and mutually agreed protocol for the specific research intended. When considering a research proposal, whether funded in whole or part by industry, the Trust will wish to consider how the continuing

costs of any pharmaceutical or other treatment initiated during the research will be managed once the study has ended.

(3) Separate Guidelines exist for pharmaceutical company Sponsored Safety

Assessment of Market Medicines (SAMM) which remain in force.

(4) Where R&D is primarily for commercial purposes, NHS providers are expected

to recover the full cost from the commercial company on whose behalf it is carried out. (HSG (97)32, paragraph 7). An industry-sponsored trial should not commence until an indemnity agreement is in place; see the guidelines in HSC

(96)48 NHS Indemnity, Arrangements for Clinical Negligence Claims in the NHS. A standard form of indemnity agreement, agreed with ABPI, can be found

at Annex B of that guidance. (5) The NHS should benefit from commercial exploitation of intellectual property

derived from R&D that the NHS has funded, or for which it has been funded, even where the intellectual property itself is owned by people outside the NHS.

The Trust shall ensure that an agreement to this effect is included in any contracts concerning R&D. The guidelines in HSC 1998/106 Policy Framework for the Management of Intellectual Property within the NHS from R&D should be

followed.

Paragraph 28 of HSG (97)32 states: At present, industry frequently contributes to the costs of pharmaceuticals (and other products) which are the subject on non-

commercial R&D in the NHS. Although by definition such items constitute Treatment Costs, the NHS will continue, under the Partnership Arrangements, to look to

researchers and non-commercial research funders to secure such contributions before approaching the NHS for support.

Reference: Commercial Sponsorship – Ethical Standards for the NHS, DoH, November 2000



Policy Details

* For more information on the consultation process, implementation plan, equality impact assessment,

or archiving arrangements, please contact Corporate Governance

Review and Amendment History

Version Date Details of Change

1.1 Dec 2016 Minor amendments including new policy format, revised

Legislation and Policy links

1.0 Oct 2014 New policy for BCPFT following alignment of policies

Title of Policy Working with the Pharmaceutical Industry Policy

Unique Identifier for this policy BCPFT-MM-POL-06

State if policy is New or Revised Revised

Previous Policy Title where applicable Working with the Pharmaceutical Industry

Policy Category

Clinical, HR, H&S, Infection Control etc. Medicines Management

Executive Director

whose portfolio this policy comes under Chief Pharmacist

Policy Lead/Author

Job titles only Deputy Chief Pharmacist

Committee/Group responsible for the approval of this policy Medicines Management Committee

Month/year consultation process completed * November 2016

Month/year policy approved November 2016

Month/year policy ratified and issued December 2016

Next review date December 2019

Implementation Plan completed * Yes

Equality Impact Assessment completed * Yes

Previous version(s) archived * Yes

Disclosure status ‘B’ can be disclosed to patients and the public

Key Words for this policy Pharmaceutical Industry, Declarations of Interest, Pharma

Working with the Pharmaceutical Industry

Documents

Transcript of Working with the Pharmaceutical Industry