CODE OF PRACTICE ON INTERESTS
FOR CHAIRMEN AND MEMBERS OF
THE BRITISH PHARMACOPOEIA
COMMISSION
Contents
1. Introduction
2. Scope
3. Definitions
4. Interests which need to be declared
Personal
interests
Non-personal
interests
Other
relevant interests
Attendance
at conferences, scientific meetings &
similar
Discretionary
fund
5. Experts attending for the day and other experts
called to advise
6. Declaration of interests
Annual
declaration
Declarations
at meetings
7. Participation in discussions when interest has been
declared
Personal
interests
Non-personal
interests
Other
interests
Rival
products
8. Record of interests
9. Publication of interests
CODE OF PRACTICE FOR CHAIRMEN AND MEMBERS OF THE BRITISH PHARMACOPOEIA COMMISSION
1.
INTRODUCTION
Purpose
of the Code
1.1
This Code of Practice sets out the rules to be followed
by chairmen and members of the British Pharmacopoeia Commission (BPC) holding
and declaring interests in the pharmaceutical industry. The Code of Practice
also provides guidance on holding and declaring other relevant interests, and
on how interests that have been declared will be managed. Separate rules apply
to chairmen and members of all the statutory committees and Expert Advisory
Groups (EAGs) established to give advice to the Licensing Authority and
Ministers on the regulation of medicines available on the
Importance
of impartiality
1.2 Ministers expect the advice they receive on matters relating to the regulation of medicines to be impartial. Ministers also expect to be able to seek such advice from a wide range of highly skilled professionals who are senior and well regarded in their respective fields. Many experts in the field of medicines have, or have had, connections with the pharmaceutical industry and other commercial organisations whose business may be considered relevant to their work on the advisory bodies but may have an impact on their impartiality. For example, the University department for which an individual is responsible may have received a research grant from industry, or the individual may have shareholdings from previous industry employment.
1.3 To reassure Ministers and the public that the advice on which decisions about medicines is based is impartial, it is important to have in place a robust policy governing the declaration and management of relevant interests. In the interests of transparency and accountability, this Code of Practice, the declarations made by chairmen and members of the BPC, and the actions taken to manage potential conflicts of interest are made public. In addition, where an individual has declared in advance of a meeting an interest that would disqualify him or her from the relevant discussions, this information will be used by the secretariat to ensure that, wherever possible, the relevant committee papers are not sent to that individual.
2. SCOPE
Committees
to which the Codes apply
2.1 This Code of Practice applies to the chairman and members of the BPC, and takes account of the fact that their role and remit differs from the other committees. There is a separate Code of Practice that applies to the following committees and groups:
·
The Expert Advisory Groups (EAGs) established by the CHM and/or the Section 4
committees.
3.
DEFINITIONS
3.1 For the purposes of this Code of Practice,
the following definitions apply:
Pharmaceutical
Industry
3.2
“Pharmaceutical industry” means:
·
Companies, partnerships or individuals who are
involved with the manufacture, sale or supply of medicinal products, including
herbal medicinal products and homoeopathic products;
·
Trade associations representing companies
involved with such products;
·
Companies, partnerships or individuals who are
directly concerned with research, development or marketing of a medicinal
product, including herbal medicinal products and homoeopathic products which is
being considered by the CHM or by one of the Section 4 committees or Expert Advisory
Groups.
References
to “the pharmaceutical industry” include cases involving a single company.
Immediate
family
3.3
“Immediate family” means:
Spouse or partner and members of the family living in the same household. Members of the family include dependent children, any adult children or other relative (such as parent) living in the same household.
4.
INTERESTS WHICH NEED TO BE DECLARED
Summary
of interests that need to be declared
4.1
It is the responsibility of each individual to
identify and to declare all relevant interests. The following types of interest
must be declared by chairmen and members of the BPC:
·
Their own financial interests in the
pharmaceutical industry (financial interests are either personal or
non-personal, and, where a product is under discussion at a meeting, either
specific to that product, or non-specific);
·
Financial interests in the pharmaceutical
industry held by members of their immediate family;
·
Any other matter that could affect
their impartiality, or that could reasonably be perceived as affecting their
impartiality. Some examples of interests that are relevant in the
context of this Code of Practice, not all associated with the pharmaceutical
industry, are set out in section 4.7 below.
4.2 The following paragraphs describe in more detail the types of interests that must be declared. The procedures for handling interests that have been declared are described in Section 7.
Personal
interests
4.3
A personal interest in the context of this
Code, involves the payment, in any form, to an individual personally, by a
pharmaceutical company whose business may be directly affected by the advice of
the advisory body. At a meeting, personal interests must be declared as specific
(that is, payment relates to a particular product under consideration), or as non-specific
(that is, not related to the particular product under discussion). The following main examples of interests to be
declared should not be regarded as a definitive list, and the Medicines and
Healthcare products Regulatory Agency (MHRA) secretariat to each committee will
advise if a chairman or member is in any doubt.
Consultancies:
any consultancy, directorship, position in or work for
the pharmaceutical industry which attracts regular or occasional payments in
cash or kind;
Fee-paid
work: any work
commissioned by the pharmaceutical industry for which the individual is paid in
cash or kind;
Shareholdings: any
shareholding in or other beneficial interest in the pharmaceutical industry.
This does not include shareholdings through unit trusts or similar arrangements
where the individual has no influence on financial management;
Expenses/hospitality
provided by a pharmaceutical company: special rules apply
to attendance at conferences or similar events. These are covered in paragraphs
4.8 et seq. below;
Unit
trusts and similar: Assets over which chairmen and members and/or their
immediate family have no financial control (such as holdings in a wide share
portfolio - Unit Trust or similar - where the Fund Manager has full discretion
over the composition of the portfolio) do not need to be declared. However,
funds held in a portfolio in which chairmen and members and/or their immediate
family have the ability to instruct the Fund Manager as to the composition of
the fund must be declared.
Pension entitlement Accrued pension rights from earlier employment in
the pharmaceutical industry do not need to be declared.
Personal interests - special rules applicable to the BPC
4.4
The BPC does not advise on licensing matters but advises
on the publication of the British Pharmacopoeia and on British Approved Names.
Its members are not prohibited from holding personal interests in the
pharmaceutical industry, but they must comply with this Code of Practice in
respect of declaring personal interests. Where such an interest is declared,
members will be permitted to take part in discussions at the chairman’s
discretion and following advice from the MHRA secretariat where appropriate.
4.5
The chairman of the BPC is not permitted to hold any
current personal interests in the pharmaceutical industry. He or she is
required to make a declaration on appointment that he/she is disposing /have
disposed of any such current personal interests.
4.6
The chairman has three months from the date of
appointment to dispose of any current personal interests in the pharmaceutical
industry. During this period, he/she is required to declare any relevant
current personal interests at meetings and should not take part in any
consideration or discussion of the relevant product(s) or any vote in relation
to the product(s).
4.7
A non-personal interest in the context of this
Code, involves payment that benefits a department for which an individual is
responsible, but is not received by the member personally. As with personal
interests, non-personal interests at a meeting must be specific or non-specific. The
main examples that follow should not be regarded as a definitive list, and the
advice of the committee secretariat provided by the MHRA should be sought if a
chairman or member is in any doubt.
Fellowships:
the holding of a fellowship endowed by the
pharmaceutical industry or any other relevant industry;
Support
by the pharmaceutical industry or any other relevant industry: any
payment, other support or sponsorship by the pharmaceutical or other industry
that does not convey any pecuniary or material benefit to the individual
personally but that benefits his/her position or department;
Grants
from a company: for example, for the running of a unit or
department for which an individual is responsible;
Grants
or fellowships to sponsor a post or staff member in the unit for which the
individual is responsible: this does not include
financial assistance given to individual students;
Commissioning
of research or other work or advice from staff who work in a unit for which the
individual is responsible.
4.8
It is not only financial interests in the
pharmaceutical industry that are relevant. A wide range of other matters may
also be considered to be relevant, depending on the circumstances and matters
under consideration by a committee on which an individual serves, and could
include non-financial interests. There are no hard and fast rules concerning “other” interests that need to
be declared. The legal rule against bias in the decisions and proceedings of
public bodies can be stated as follows: if a fair-minded and informed observer
would conclude, in all the circumstances, that there is a real possibility of
bias, the member should not take part in proceedings. It is therefore not
relevant that the member himself believes that he is unbiased, impartial or has
an open mind. In considering whether an interest is relevant and should be declared,
the guiding principle must be whether the matter might reasonably be perceived
as possibly affecting a member’s impartiality. Some examples of matters that might fall under this
heading are set out below. These are not exhaustive and individuals should
always seek advice from the MHRA Secretariat if they are in any doubt about
whether or not a matter is relevant:
Attendance at conferences, scientific meetings and similar
4.9 Government recognises that it is usual for conferences, scientific meetings and other events associated with healthcare, medicines or related matters to receive some form of sponsorship either directly, or indirectly via a special fund, from the pharmaceutical industry. Government also recognises the importance of being able to receive advice from leading experts who are able to keep themselves up to date with developments at the cutting edge of science, and that this is mainly done through attendance at educational and scientific events and meetings. It is therefore essential to set out rules for attendance at these and similar events as questions may be legitimately raised as to whether participation in the event, or even mere attendance, will compromise their impartiality in any way.
4.10 The nature of the events that fall within the scope of this Code of Practice and the industry sponsorship received can vary widely from, at one extreme, a conference sponsored by a single company to launch a product to, at the other extreme, a scientific meeting organised by a learned society that has received some financial support from a number of companies paid into a dedicated meeting fund. Between these extremes there are many variations in events and funding that may occur.
4.11 Ministers have established a discretionary fund to meet the reasonable expenses (e.g. travel and accommodation costs) incurred in the attendance by committee chairmen and members who are not permitted to hold personal interests in the pharmaceutical industry. It is therefore also available to the chairman of the BPC. The MHRA committee secretariat will administer the fund, and the chairman must make an application in good time to enable appropriate travel and other arrangements to be made. The fund will cover educational events that are relevant to maintaining his/her expertise, where acceptance of financial support from industry (for example a single pharmaceutical company) would not be appropriate. Separate guidance on the allocation of resources from the fund has been developed for use by the MHRA secretariat.
4.12 In some cases it will be permissible for the BPC chairman to attend events sponsored by the pharmaceutical industry (and accept the payment of expenses) without recourse to the MHRA discretionary fund. For example, where a learned society holds an international conference that is funded by a number of different pharmaceutical companies, it will generally be acceptable for the chairman to accept such an invitation and to receive payment of expenses, although in such instances declaration of attendance and receipt of funding must be declared in the normal way. On the other hand, it would not be acceptable for him to receive payment in relation to a conference wholly funded by the pharmaceutical industry and where its primary purpose was to promote a product or a particular class of products.
4.13
If funding and/or expenses are paid specifically for
his/her attendance but nevertheless paid to his/her department rather than the
individual himself, it will not normally be acceptable for the individual to
attend.
4.14 Benefits
of this nature paid to an immediate family member that also benefit the BPC
chairman (e.g. a company pays his or her flight costs so that he or she can
attend a conference with a family member) must be declared as the individual’s
own interest. However, there
is no requirement to declare educational conferences and similar events
attended by immediate family members.
4.15 The rules for holding personal interests in the pharmaceutical industry do not apply to members of the BPC, and for the reasons set out in paragraph 4.4 above. Therefore, these experts may attend meetings sponsored by the pharmaceutical industry and accept funding of expenses, but these must be declared.
4.16 Attendance at conferences, scientific meetings and other events relevant to this Code must be declared as soon as practicable and not later than the first meeting of the committee after the event has taken place. This declaration may affect an individual’s participation in discussions over the subsequent months. The declarations will be published annually in the report of the work of the committees.
4.17
The situations described are
not exhaustive and individuals should always seek advice from the MHRA
Secretariat if they are in any doubt about whether or not they should attend,
or whether, having attended, they need to declare attendance as an interest.
5. SPECIAL
POSITION OF EXPERTS ATTENDING FOR THE DAY AND EXPERTS CALLED TO ADVISE THE
COMMITTEE ON SPECIFIC ISSUES
5.1
Experts
who are invited to attend committees for the day, for example if a regular
member cannot be available or cannot participate in discussions because of his
or her interests, are known as “Experts for the Day”. They are co-opted as full
members of the committee for that day, may participate fully in all discussions
and may vote. They are therefore required to make a full declaration of
interests in the same way as is required of a full member of that committee. In addition, experts may be invited to advise
the committee on particular issues, without being co-opted as members. Such
experts should not hold personal interests in the issue under discussion.
6.
DECLARATION OF INTERESTS
6.1 Chairmen and members are required to make a full declaration of interests on appointment and annually. They must also inform the MHRA secretariat promptly of any changes or updates to the terms of their declaration during the year. This includes reporting promptly attendance at events described in paragraphs 4.8 – 4.17. If an individual is uncertain as to whether or not an interest should be declared, he or she must seek guidance from the MHRA secretariat. The Chairman and members are also required to make further declarations of relevant interests at meetings when they will be advised as to the procedure that will apply.
Annual declaration
6.2 The annual declaration must include all the financial (personal and non-personal) interests in the pharmaceutical industry of the chairman and members currently held or held in the last 12 months and financial interests in the pharmaceutical industry that they know of that are held by their immediate family. Members and the chairman are also required to include in the annual declaration details of any other matter which could reasonably be regarded as affecting their impartiality.
6.3 The declaration of certain interests will not be restricted to the last 12 months.
6.4 The chairman and members’ declaration of their own interests will identify them with the interests declared, but the interests declared do not need to be quantified. For example, in declaring a grant received by a department for which the individual is responsible, only the company name is required, not the value of the grant.
6.5 When the annual declaration includes matters relating to other persons, names are not required, nor do the interests declared need to be quantified. For example, in declaring shareholdings only the company name is required, not the numbers or values of shares held. Family members should be referred to simply as: “immediate family member” and closely connected persons as “other person”. In nearly all circumstances this will protect the anonymity of those whose interests must be declared by the serving committee member, although we recognise that in very exceptional circumstances it may be possible for that individual to be identified.
6.6 The annual declaration made
by the chairman and members of the BPC will be published each year in the
Annual Report of the Advisory Bodies.
6.7 The chairman and members are required to declare relevant interests
at meetings, whether or not those interests have previously been declared to
MHRA. The type of interest must be declared, that is, whether it is personal or
non-personal, specific or non-specific or other.
6.8 If an issue arises for discussion and an
individual is concerned about a matter that could be regarded as affecting his
or her impartiality and this matter has not already been declared, he or she
must raise this with the MHRA secretariat in advance of the meeting if
possible. This will enable the secretariat, wherever possible, to ensure that a
member is not sent any papers concerning matters in which he or she has an
interest that would disqualify them from proceedings. Where it has not been
possible to identify such issues in advance, the individual must raise the
issue with the MHRA secretariat or the chairman as early as possible before the
meeting takes place, and in any event before discussion of the relevant agenda
item. The chairman of the committee is responsible for taking the decision on
how declared interests should be handled.
7. PARTICIPATION IN
DISCUSSIONS WHEN AN INTEREST HAS BEEN DECLARED
7.1
“Taking part in discussions”
means speaking at meetings or voting. Where an individual is not to take part
in a discussion, he or she should leave the room before the discussion
commences, and return only when that agenda item is complete.
7.2
The following paragraphs
describe, for each category of interests declared, the actions to be taken.
Personal Interests
7.3 A member must declare a personal specific interest
if an individual has worked on the product under consideration and is receiving
or has received payment for that work. As a general rule, the individual will
normally not be allowed to take part in discussions as they relate to that
product, except where the Chairman exercises his discretion (which will be
rarely exercised) to answer questions from other members. A significant
involvement in the development of a product will usually debar an individual
from ever participating in discussion on that product. A less significant
involvement, or less specific work with or on a product, may not permanently
debar an individual, but such decisions will need to be taken on a case by case
basis, taking account of the nature of the involvement, its specificity and
when the work was undertaken.
7.4
If an individual has declared a personal non-specific interest the individual must take no part in
discussions on that agenda item, except at the Chairman’s discretion to answer
questions from other members. If the personal non-specific interest relates to
shares that have been disposed of, the individual will generally be permitted
to take part in discussions once three months have elapsed from the date of the
disposal of them If the personal non-specific interest relates to other
matters, such as a payment received from a pharmaceutical company, the
individual will generally be permitted to take part in discussions once 12
months has elapsed from the date of receipt of payment. However, in some cases
it will not be appropriate for the individual to take part even though 12
months have elapsed – for example, where he has an ongoing consultancy or other
financial relationship with the pharmaceutical company.
7.5
If the individual
has declared a personal interest in relation to a member of his or her
immediate family, he or she should similarly take no part in discussions except
at the Chairman’s discretion to answer questions from other members. Such
interests may range from a family member’s major role in the development of a
product under consideration to a family member’s shareholdings.
Non-Personal Interests
7.6
A member must declare a non-personal specific
interest if the department for which
the individual is responsible is currently receiving payment in respect of work
done on the product. The individual will generally not be able to take part in
proceedings where a department for which he has responsibility has carried out
specific work on the product under discussion.
7.7
A member must declare a non-personal, non-specific
interest if their department is currently receiving payment which does
not relate to the product under discussion. Such an interest will not normally
debar an individual from taking part in discussions, unless exceptional
circumstances arise in which it is not appropriate for them to do so.
7.8
If an individual
declares non-personal interests of an immediate family member, this will not
generally prevent him or her from taking part in discussions.
Other Interests
7.9
If an individual has declared
an interest which does not fall within one of the categories described, but
which he or she considers could be perceived as affecting his or her
impartiality, whether that individual will be permitted to take part in
discussions will depend upon the circumstances. In some cases, it will be
sufficient for the individual to declare the interest, so that others taking
part in the discussion are aware of his or her interests and can view his or
her contribution in that light. In other circumstances it may not be
appropriate for an individual to take any part in discussions, except at the
chairman’s discretion to answer questions from other members. The chairman
and/or the MHRA Secretariat will advise on these matters. The chairman of the
committee is responsible for taking the decision on how declared interests
should be handled.
Rival Products
7.10
It is important to remember
that not only the company whose product is being considered will be affected by
the advice that is given by advisory bodies – companies who make competitor
products may also be affected.
7.11
If a product is being discussed and an individual is
aware that he or she has an interest in a company which markets a rival or
competitor product, the business of which will directly benefit or suffer as a
result of the advice that is given, the individual must declare that interest
at the meeting. An example might be a change to the publication as a result of
information provided by another company, or a new monograph that would apply to
a number of a company’s products. Interests in a competitor company should be
declared as personal or non-personal and specific or non-specific, in the usual
way. Whether the individual will be permitted to take part in discussions will
depend upon the circumstances and the extent to which the business of the
competitor is likely to be affected. In relation to personal interests in a
competitor, the general guideline is that unless the potential effect of the
decision on which the committee is advising is so small as to be incapable of
influencing the member’s advice, the member should not take part in
proceedings. The final decision on whether a member may take part is for the
chairman.
7.12
There is no requirement to
carry out specific research to identify issues such as these – individuals need
only to declare interests of which they are aware.
8. RECORD OF
INTERESTS
8.1
A record is kept in the MHRA
of:
·
names
of chairmen and members who have declared interests on appointment, when an
interest first arises or through the annual declaration, and the nature of the
interest;
·
names
of chairmen and members who have declared interests at meetings of the CHM,
Section 4 Committees, including the BPC, and EAGs, giving dates, names of
relevant products and companies, details of the interest declared and whether
the individual took part in the proceedings.
9.1 Interests
declared to the MHRA by chairmen and members of all committees, including EAGs,
will be published each year in the Annual Reports of the CHM and Section 4
Committees (normally published in July).
9.2
Interests of immediate family and other closely
connected people declared by chairmen and members will be included in the
Annual Reports. This information will provide only the name of the committee
chairman or member, the source of the interest (e.g. the company name), will
not provide any financial information nor numbers (e.g. for shares) nor
identify the family member or other holding the interest by name.