Memorandum by Mr Paul Flynn, MP (PI 38)
This Memorandum is relevant to the following
terms of reference:
The Committee's decision to undertake this inquiry
is warmly welcomed. This brief report is intended to add to and
to support fully the submissions to the Committee by MIND and
Charles Medawar.
The focus of this memorandum is the relationship
between pharmaceutical companies and patients' organisations and
lack of regulation of this relationship. These relationships have
developed partly as a consequence of legislation preventing "direct-to-consumer"
advertising and need of pharmaceutical companies to find other
means of marketing medicines. They are driven by the demand for
profits in an increasingly competitive sector. The ban on "direct-to-consumer"
advertising should remain in place.
While on the surface this relationship
appears to be "win-win" for both parties, the power
undoubtedly lies with the pharmaceutical companies, who according
to the Association of the British Pharmaceutical Industry (ABPI),
are worth almost as much as North Sea oil to the UK economy.[1]
There are very serious concerns that pharmaceutical
companies are using patient's organisations as conduits to promote
their products in a subtle form of marketing. There is a complete
lack of transparency in the regulation of these relationships
and few formal legal requirements. Instead of representing the
interests of patients, groups in some cases have become marketing
tools for the pharmaceutical companies and this raises serious
concerns about their credibility.
PATIENTS ORGANISATIONS
The Consumers' Association estimates that there
are more than 200 national patient organisations and support groups
in the UK.[2]
Medical research charities and groups representing particular
medical conditions receive around 25% of total donations made
each year from all donors.[3]
A substantial amount of this money comes from pharmaceutical companies
and is used for a number of purposes including the funding of
leaflets and sponsorship of campaigns. Patients' organisations
perform many roles including providing information to the general
public and representing those who suffer from a particular medical
condition. Increasingly they are campaigning bodies, fighting
for access to a particular drug. Naturally this coincides with
the interests of the producers of drugs.
A survey[4]
carried out to illustrate this memorandum gives a snapshot of
the extent of this relationship and how the money is used. Many
of the groups contacted provide support for All-Party Groups within
the House of Commons, which is another area of concern within
this broader topic. The groups supporting APPGs do not have to
declare their interests and given that many of them have links
with pharmaceutical companies, there is a danger that it is an
indirect form of lobbying for those companies.
The survey revealed a number of concerns about
this financial relationship and the way it is regulated or rather
the way it is not regulated. Each organisation was asked for details
of the funds it received.
|
| Organisation | Receipt of funding from pharmaceutical companies
|
|
| Stroke Association | Yes
|
| National Osteoporosis Society | Yes
|
| Arthritis Care | Yes
|
| Alzheimer's Society | Yes
|
| Sane | Yes
|
| Backcare | Yes
|
| MS Society | Yes
|
| Migraine Action | Yes
|
| Alcohol Concern | No
|
| Cancer BACUP | Yes
|
| British Lung Foundation | Yes
|
| Breakthrough Breast Cancer | Yes
|
| Motor Neurone Disease Association | Yes
|
| Haemophilia Society | Yes
|
| Action for ME | No
|
| Diabetes UK | Yes
|
| National Kidney Federation | Yes
|
| Crusaid | Yes
|
| Muscular Dystrophy Campaign | No
|
| Young Minds | No
|
| MIND | No |
| Depression Alliance | Yes
|
| National Autistic Society | No
|
| British Heart Foundation | Yes
|
|
The vast majority of organisations do receive donations of
varying amounts, although a handful did not accept donations from
pharmaceutical companies.[5]
In its response, Young Minds, a charity supporting young people
with mental problems stated, "It is YoungMinds policy not
to enter into financial partnerships with Pharmaceutical companies.
This enables the organisation to maintain its independence and
avoid any possible instances of compromise."
A similar survey carried out by Patient View for HSC News
found that 76% of EU-based patient groups received funding from
pharmaceutical companies to pay for occasional projects.[6]
Many organisations who declare funding from pharmaceutical
companies do so along side a policy document governing the relationship.
The extent to which these organisations revealed the identity
of the donors varied a great deal. Some merely printed their names
and donations were recorded as a total. There was only one case
where the individual donations of each company recorded.[7]
One organisation, SANE, was "reluctant to provide company
names due to the Data Protection Act,"[8]
and another explained why it did not publish detailed accounts
by saying, "this would embarrass the smaller supporting companies
by way of comparison."[9]
Interestingly, the HSC News survey recorded that 14% of EU-based
groups declared using revenue from pharmaceutical companies for
core costs, which suggests the survival of groups is not dependent
on the support of these companies.[10]
There would therefore be no disadvantage in fully declaring funding
or perhaps being more circumspect in accepting it in the first
place.
While the mere act of receiving money from a company does
not necessarily lead to a group being used by a pharmaceutical
company or having questionable independence, there are examples
of groups who have not been critical of their sponsors when products
have been found to be ineffective. A major part of the problem
is that many of the links are not clear.
— The Alzheimer's Society, which campaigned strongly
for access a drug called Aricept and cost the NHS £39 million
a year. A study paid for by the NHS found the drugs to be ineffective.
In response to this, a statement was released by the drugs' companies
which went out in the name of the Society. The Society does receive
funding from these companies.[11]
— The Impotence Association, which campaigns for
wider availability of impotence treatments. It receives funding
from Pfizer, the makers of Viagra, for its website, which makes
no statement of editorial independence.[12]
— A public relations agency called Phase IV contacted
me via e-mail in July 2004 asking for my views on a campaign they
were putting together to increase funding for anti-TNF drugs used
for the treatment of arthritis. The campaign proposal included
plans to contact patient groups to demonstrate the worth of anti-TNF
drugs. It later transpired that the agency would be seeking support
for this from pharmaceutical companies and had already approached
the National Rheumatoid Arthritis Society. Regardless of the fact
that doubts surround the effectiveness of anti-TNF drugs, this
highlights the role of PR agencies in acting as a third party
for pharmaceutical companies, adding a further shade of grey to
an already unclear situation.
— There is world wide alarm because of the effects
of the Selective Serotonin Uptake Inhibitors and allegations that
information from clinical trials has been suppressed. A courageous
leading campaign has been pursued by MIND who receives no contributions
from any pharmaceutical company. There has been silence from SANE
and Depression Alliance who accept donations. I have been in contact
with all three organisations. There are grounds for suspicion
that, at best, donations may have an inhibiting effect on the
two latter groups. This may explain why they have failed to add
to the concerns eloquently expressed by MIND.
— Following the suicide of a constituent who was
using the drug Roaccutane for persistent acne, I investigated
the alleged link with the use of the drug and other suicides.
While no causal links have been established there is widespread
international concern. A newspaper alleged that an Acne patients
group failed to act on behalf on their clients to investigate
any possible link. They also alleged that the group received a
substantial annual grant from the company that produces Roaccutane.
Some groups have been critical of their sponsors, although
examples are few and far between. The National Kidney Federation,
in response to the survey detailed on page, reported that it had
been critical of some of its sponsors and supported the introduction
of generic drugs, which would have a serious effect on the market
share of those sponsors.[13]
PROBLEMS WITH
EXISTING REGULATION
The regulation of charities with regards their relationship
with pharmaceutical companies lacks transparency and is fundamentally
flawed.
While the Charities Act 1992 charges trustees with the responsibility
of deciding whether donations are in the charities' interests,
this specifically relates to the financial position of the charity.
Patient's organisations share the same interests of pharmaceutical
companies, so in general refusing funding would be difficult.
Although charities with an income of over £10,000 per
annum are required to submit accounts to the Charity Commission
in a defined format, a representative of the Commission confirmed
that "the requirements to provide information on the source
of donations are less stringent than those relating to the expenditure
of the charity."[14]
There is no requirement to publish the names of all donors
and how much they have contributed as was noted on page 3. "Under
the charity accounting regulations (SORP) there is no general
requirement for charities to disclose the sources of their donations."[15]
Transparency is lacking because there is no legal requirement
for it. The Charity Commission and other similar bodies can only
really contribute in an advisory role to how this relationship
is regulated.
The Long Term Medical Alliance (LMCA) is an umbrella body
of patient organisations. It publishes guidelines for groups to
consider in their dealings with the pharmaceutical industry. The
LMCA has no way of enforcing or monitoring this. "To make
them work, however, would need monitoring, enforcement, and sanctions,
with compliance as a condition of membership of the alliance—a
distant hope."[16]
This lack of transparency is confirmed by the findings of the
HSC News survey, which found that only 26% of UK based groups
surveyed had drawn up a "conflict-of-interest" statement.[17]
Equally, the Institute of Fundraising publishes a code for
its members, which it expects them to adhere to. It recommends
as best practice to establish a policy of working with companies
and recognises that "In this competitive age the reasons
for a company wishing to work with a charity are seldom purely
philanthropic."[18]
PHARMACEUTICAL COMPANIES
As mentioned in the opening paragraphs, pharmaceutical companies
face limits on advertising and patients' groups offer a platform
to reach members of the public. Patient groups campaigning for
disease awareness or the availability of latest drug inevitably
attract such interest. Consequently it pays to support these groups
and in some cases companies have gone as far as creating a group.
"In 1999 Biogen set up Action for Access in their effort
to get the NHS to provide interferon beta for multiple sclerosis."[19]
This promotion was stopped as it breached guidelines.
PROBLEMS WITH
EXISTING REGULATION
Pharmaceutical companies in UK are governed by, among other
things, the Medical and Healthcare Regulatory Agency. One of its
roles is to regulate the promotion of drugs, but its approach
to breaches is to seek a negotiated resolution in the majority
of cases. The emphasis is very much on self-regulation and it
is well-documented that the MHRA is populated by people with links
to pharmaceutical companies[20]
and is funded 100% by the industry. Little mention appears to
be made of patients' organisations specifically and this leads
to the suspicion that there is a gap between two different types
of bodies governed by their own codes.
The ABPI publishes a code of practice, but again the emphasis
is on self-regulation. Complaints are dealt with by a separate
body, The Prescriptions Medicines Code of Practice Authority (PMCPA).
The code governs advertising and sponsorship, but again it is
self-regulatory and has very little to say about relationships
with patients' organisations and individual donations. Out of
a board of 12, six members belong to the pharmaceutical industry.
In 1994, the Health Select Committee reported that, "We are
not convinced that the present voluntary code is being rigorously
applied."[21]
The ABPI itself recognised the value of relationships with
patients' organisations. During a campaign in 2000 to relax direct-to-consumer
advertising within the EU, it described its battle plan as "to
employ ground troops in the form of patient support groups, sympathetic
medical opinion and healthcare professionals. This will have the
effect of weakening political, ideological and professional defences."[22]
The PMCPA publishes notes of each case it considers and sent
a selection of those mentioning patient groups. They highlighted
that PMCPA only really considers advertising and sponsorship,
and does not extend to individual donations or the regulation
of relationships. A few examples can illustrate both the influence
of pharmaceutical companies and the limited role of the PMCPA.
— Case AUTH 498/2/97 Consultant Psychiatrist v Bristol-Myers
Squibb
Allegation that a booklet for Depression Alliance supported
by Bristol-Myers Squibb was a subtle advert for a drug called
Dultonin. The drug was not mentioned by name and the complaint
was dismissed. Even so, this is illustrative of the relationship
and the concern of a lack of transparency,
— Case AUTH 1455/4/03 General Practitioner v Pharmacia
Complaint that a campaign called the Public Health Education
Campaign sponsored by Pharmacia constituted direct advertising.
The campaign had the appearance of a public health campaign and
involved two patient organisations, The Continence Foundation
and Incontact. A specific drug was not mentioned, but patients
were encouraged to consult their doctor. While the complaint was
dismissed, it was noted that a phone line established as part
of the campaign failed to declare the involvement of Pharmacia
and was misleading. Again, this illustrates the problematic nature
of this relationship.
— Case AUTH 1316/5/02 Novartis v Fujisawa
Novartis complained that Fujisawa had been involved in a
promotional article in the magazine of the National Kidney Foundation.
The article was drafted by Fujisawa's public relations agency
and no declaration of Fujisawa's involvement was made. This was
found to be a breach of the code, but the complaint itself was
dismissed.
RECOMMENDATIONS
Self-regulation of a one-sided, unbalanced relationship is
flawed. While it might be argued that philanthropy is a private
affair, the increasing role of patient organisations in providing
services and campaigning and the power of pharmaceutical companies'
demands reform. Measures should be considered to increase transparency
and accountability and guarantee a greater measure of independence
of patients' organisations. The Draft Charities Bill offers an
opportunity to clarify the regulation relating to funding relationships
where it states, "The Home Secretary would be given power
to introduce statutory regulation of fundraising if he deems self-regulation
to have failed."
— Mandatory requirement for patients groups to publish
a policy (conflict-of-interest) document detailing their approach
to relationships with corporate donors.
— Mandatory requirement for patient groups to publish
all donors and their donations.
— Codes of practice should be amalgamated and made
a compulsory requirement of registered charities. Monitoring of
this code should be carried out by an independent body, possibly
the Charity Commission.
— Require all groups who support APPGs in the House
of Commons to declare their interests.
— Mandatory requirement for pharmaceutical companies
to publish a policy document detailing their approach to relationships
with patient organisations.
— Mandatory requirement for pharmaceutical companies
to publish all donations made and recipients of those donations.
— Reform of the regulatory bodies of pharmaceutical
companies to establish them as completely independent of vested
interests and strengthen their powers and scope of responsibility
to enforce mandatory requirements set out above.
— Increase public funding for independent sources
of health information.
1
"Pharmaceutical Industry trade surplus higher than expected"
ABPI press release 19 May 2004. Back
2
"Who's injecting the cash?" Consumers' Association
April 2003. Back
3
"The eccentric world of British philanthropy" The Independent
Maxine Frith and Nigel Morris 28 May 2004. Back
4
Survey carried out through my office by writing to a selection
of patient groups chosen at random. Back
5
These included the Muscular Dystrophy Campaign, Young Minds,
Action for ME, Alcohol Concern, MIND. Back
6
"Fundraising and the growth of industry involvement."
HSC News Issue 6 April 2004 Published by Patient View p 29. Back
7
Alzheimer's Society. Back
8
Letter from Chief Executive of SANE April 2004. Back
9
E-mail from Chief Executive of National Kidney Federation June
2004. Back
10
"Fundraising and the growth of industry involvement."
HSC News Issue 6 April 2004 Published by Patient View p 26. Back
11
"Alzheimers' drugs a waste of money, says NHS study"
Sarah Boseley, The Guardian 25 June 2004. Back
12
"Who's injecting the cash?" Consumers' Association
April 2003. Back
13
E-mail from Chief Executive of National Kidney Federation June
2004. Back
14
"Funding of charities/patient groups" Dr Kate Haire
Science and Environment Section House of Commons' library. Back
15
Letter from Director of Policy and Strategy at the Charity Commission. Back
16
"Relationships between the pharmaceutical industry and patients'
organisations" Andrew Herxheimer BMJ 2003;326:1208-1210 (31
May). Back
17
"Fundraising and the growth of industry involvement."
HSC News Issue 6 April 2004 Published by Patient View p 59. Back
18
Institute of Fundraising Codes of Fundraising Practice 2004 p
16. Back
19
"Relationships between the pharmaceutical industry and patients'
organisations" Andrew Herxheimer BMJ 2003;326: 1208-1210
(31 May). Back
20
A survey of the Annual Report 2002 of the MHRA found that of
the 34 members of the main committee, 17 declare personal interests,
which include having received travel expenses, fees, employment
as consultants and the ownership of shares. 14 of the 34 declare
non-personal interests such as the receipt of research grants.
All the main pharmaceutical companies are represented, from Astra
Zeneca to Roche and the trend continues through the various sub-committees
of the CSM. Back
21
House of Commons Health Select Committee. Back
22
"The Mark of Zorro" Michael Jeffries Pharmaceutical
Marketing May 2000. Back
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