APPENDIX 26
Memorandum by Mel Read (PI 100)
EVIDENCE FOR
CONSIDERATION FOR
THE HOUSE
OF COMMONS
COMMITTEE INQUIRY
INTO THE
INFLUENCE OF
THE PHARMACEUTICAL
INDUSTRY
Background
I was a Labour Member of the European Parliament
from 1989-2004 and during that time served on the Industry Committee
of the Parliament. I come from a trade union background and my
union, now Amicus, represents a range of professional workers
in the health service, and also has a substantial membership in
the pharmaceutical and medical devices industries.
I attach a CV which will give the Committee
some indication of the sort of work I've been involved in over
the last 15 years.[103]
Since my retirement I have taken up two unpaid positions; President
of the European Cervical Cancer Association (partly funded by
the pharmaceutical industry) and Chairman of Health First Europe,
an organisation newly set up by Eucomed, the umbrella organisation
representing the medical devices industry.
I have been lobbied by the pharmaceutical industry
over a range of issues during my time in the European Parliament.
The most recent was the European Commission proposal concerning
the placing on the market of pharmaceutical products. This was
a major Commission proposal and generated a substantial interest
both in the Parliament and in the various sections of the industry.
I attach a list of organisations who lobbied me on this particular
dossier. The reason for their lobby was that I drew up the Opinion
(attached) for the Industry, Trade, Research & Energy Committee
on the Commission proposal.
Normally, drawing up an Opinion is a comparatively
minor matter and the Environment and Public Health Committee had
the main responsibility for this dossier. However, because it
was so important for the industry, what would normally be a comparatively
minor piece of work was precisely the opposite. There was such
an intense lobby on this matter that I had to make an early decision
that I could only see each organisation once. There was just not
time physically to see people for a second time. From 1999-2004
I represented the East Midlands which contains, among many other
pharmaceutical interests, Astra Zeneca at Loughborough and Boots
in Nottingham, for whom I therefore felt a special responsibility,
and to whom I listened with particular care.
The issues were briefly these:
— The period concerning data exclusivity
— The balance between national and
central (ie European) authorisations
— New proposals from the Commission
concerning direct consumer advertising
— Parallel submissions concerning the
placing on the market of veterinary medicines
— Introduction of a BOLAR provision
There have been other Directives over the years
which interested the pharma industry over which there has been
a vigorous lobby for example:
— Directives concerning advertising
— Directives concerning labelling of
pharmaceutical products and patient information TRIPS
— Rare Diseases and Orphan Drugs Directive
— The Sixth Framework Research Programme
— REACH (proposals concerning the safety
of chemicals)
The way that the pharma industry has operated
in the European Parliament has changed quite dramatically during
my 15 years. Originally the lobby, as with many others, was broad
ranging and took the form of a meeting or lunch or social event
of some kind to which a large number of MEPs were invited. This
changed very rapidly and the pharma industry soon realised that
they needed to target particular MEPs who were either on the relevant
Committees or had been appointed as Rapporteurs (where a particular
MEP takes responsibility for steering a piece of legislation through
its various stages). Pharma companies would contact a particular
MEP, ask to visit them, produce a breakdown of a Commission proposal
with an indication of how various parts of the proposal adversely
or otherwise affected that particular section of the industry.
These position papers are extremely useful—so much so that
have declared them in my Declaration of Interest. The position
paper which was presented would usually contain suggested draft
new amendments which were more to the taste of the industry. I
must stress that this was all done properly and openly and I have
had no experience of subterfuge or an organisation not making
it absolutely clear who they were and how they were funded.
As well as this sections of the industry have
held various functions over the years in the Parliament, usually,
but not always, timed to coincide with the passing through of
legislation relevant to the pharma industry. This would usually
be sponsored by a particular MEP and indeed I have done this several
times over the last years. For example a pharma company would
book a room in the Parliament, organise a lunch and the lunch
would be led with speakers, discussion, questions, comment, argument
etc.
The Association of British Pharmaceuticals Industries
used to hold a regular supper club in Strasbourg three or four
times a year. This was most definitely not aimed at particular
pieces of legislation but was designed to foster links between
the industry and MEPs across the political spectrum and from the
UK. These were well attended, and I found them useful and interesting.
Of course the pharmaceutical industry is a major employer in the
UK, and almost every MEP had a direct interest in fostering this
relationship, as well as having strong links with universities
and research establishments.
To revert to the most recent review, the issues
between the in-patent section of the industry and the generics
section revolved around data exclusivity and the BOLAR provisions.
All sections of the industry were anxious to stress to us that
there was a real issue surrounding the future location of the
pharma industry and huge incentives (not always clearly spelled
out) for the industry to gravitate towards to the United States
of America. For all sorts of reasons I and many other MEPs feel
very strongly that it is important to have the research sector
of the pharma industry within the European Union and we listen
very carefully to any question that proposals that the Commission
come up with and or proposals that the Parliament come up with
are detrimental to the final location of the industry.
There really is something of a Catch 22 situation
with the pharma industry in the EU. They are for profit organisations
whose profits come largely from the public purse, either directly
or indirectly. There is little or no single market in the pharmaceutical
industry and the price of products which have been authorised
to be placed on the market are agreed on varies from country to
country. Indeed pharma products which have been given authorisation
are not necessarily placed on the market at all in some EU countries.
The differences in prices has meant the encouragement of parallel
trading and indeed the parallel trade association was one which
lobbied me. There was considerable irritation about the existence
of parallel trade by the in-patent section of the pharma industry
but in fact this did seem to me to be a legitimate business opportunity,
whose legitimacy has been upheld by the ECJ and is indeed of considerable
benefit to our own National Health Service. I have no data to
substantiate this but my own experience and that of others indicates
that hospital pharmacies are heavy users of parallel traded products.
Unless we can create a climate where the research section of the
pharma industry has incentives to invest money in new drugs then
there will be no generic industry. Indeed this is the argument
of the in-patent section, that the generic industry rides on the
back of research funded by the in-patent section. However, the
whole question of access to medicines which is shown at its most
stark in the controversy between the drug companies and the Government
in South Africa is an issue also in the European Union. The growth
of e-pharmacies is an illustration of how we may get a single
market by the backdoor as computer literate, usually middle-class
patients, look to the internet for pharma products and other medical
treatment. The Commission have recently come up with proposal
about patient mobility which the European Parliament is soon to
consider.
What was most interesting about the lobby on
the recent review of authorisations was the controversy surrounding
the Commission proposals on direct consumer advertising (the Commission
were unhappy about it being described thus but in fact that's
what it was). The Commission in their proposal chose three diseases—asthma,
diabetes and HIV/AIDS as pilots.
The argument was that these were three diseases
for which it was unlikely that patients would choose to take drugs
unless they were necessary ie they wouldn't be encouraged by advertising
to demand particular drugs. I was not entirely convinced by this
argument but I could see some logic in it. In fact to allow a
pilot over 10 years on just three diseases was extremely unlikely
to help in deciding whether this form of patient information could
be extended. I had many representations from patients' organisations,
all of them fully or partly funded by the pharmaceutical industry,
saying that they approved of the Commission proposals and wanted
to have more information available as patients. To be fair, the
pharma industry did have an argument, as did the Commission, in
saying that computer literate, English speaking patients already
had access to information about pharmaceutical products. But the
counter argument from the European Parliament went that if patients
were to have information, it should not be just about one company's
pharmaceutical product but about a range and it should also be
about providing information about other options (changes in lifestyle,
doing nothing, surgery whatever). In the end, and I was instrumental
in this, the Parliament voted to refer this whole matter back
to the Commission to see whether the Commission could find ways
to provide information and validate ways in which patients could
get information. I would be happy to expand on this matter verbally
if the Committee so require.
Overall, the pharma industry lobby is probably
the most effective and professional on the Russell's lobbying
scene. I have no experience of any deceit or malpractice at all,
indeed the industry is scrupulous about these matters. But this
is not to conclude that this influence is entirely without flaw.
The gap, and it is a huge gap, is that the public health lobby
has a tiny influence on policy, and that there is a conflict between
the health objectives of the EU and the Internal Market objectives.
If the way in which the pharma industry funds patients groups
is factored in, then the gaps are even wider.
103 Not printed. Back
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