Select Committee on Health Written Evidence


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:

    —  patent rules

    —  Directives concerning advertising

    —  Directives concerning labelling of pharmaceutical products and patient information TRIPS

    —  Current WTO round

    —  Rare Diseases and Orphan Drugs Directive

    —  The Sixth Framework Research Programme

    —  REACH (proposals concerning the safety of chemicals)

    —  Cosmetics legislation

  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.





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