Friday, September 15, 2006

New Labour Lobbyist caught in the breach

David Earnshaw is the MD of Burson Marsteller in Brussels.

He does this part time (3 days a week), otherwise he lectures at the college of Europe etc on European Politics, His public CV mentions that he is a former '99 New Labour MEP candidate, but doesn't mention that he is a former chair of Brussels labour etc. (he is also the co author of UKIP watch thus I have a personal animus against him, not relevant to this but hey I'm political)

"2002 - Burson Marsteller, Brussels (part time)- Managing Director,
directing and providing EU healthcare and pharmaceutical-related policy consultancy for several ,major pharmaceutical companies, trade associations and professional/medical organisations".

He was taken on as an independent expert by the European Parliament, (nothing wrong with that per se of course) and won a contract to write an independent study on what is called the Regulation for Advanced therapy medicinal products. If passed this would mean that the use of medicines that have been created through the use of gene therapy, embryo research etc would be legal across the EU. (Personally I have no problem with this, but for example the Polish have voted against it in their Parliament. The net result is that if a pole with a disease that has some medicine created this way wanted to be treated in Poland, they would be refused. Then they would, with Biotech Pharma industry support be able to take a case to the European Court of Justice that would be in a position to overrule the democratically stated opposition of a member state - much to the good of pharma's profit line)

This commission was worth 4000 euros. As a matter of interest do you believe that the MD of a major PR firm would write a 29 page technical brief for 3000 quid? His hire out rate would use up that sort of cash in 2 hours tops. More likely in my opinion is he would send the brief to one of his clients and get them to write it. Now I have absolutely no evidence to suggest he did such a thing but it does beg the question.

His study was straight down the line pro- pharma

However according to his own code of conduct,

“In their dealing with the EU institutions, public affairs consultants shall:
a) identify themselves by name and by company;
b) declare the interest represented; .....

Failure to comply with the code of conduct or the internal transparency rules will be treated as a disciplinary offence".

So when on his study See page 2, he gives his address as;

David Earnshaw
164 rue Victor Hugo,

he is, at least in my mind, in clear breach of his own transparency code.

In the last 6 months I have dug up from PR Week the following pharma links with BM Brussels

Feb 2006 BMS Bristol-Myers Squibb used speciffically in EMEA
Jan 2006 GSK GlaxoSmithKline´s for its global Seretide account.
Coorporate relationship between Merck and B-M, especailly on Vioxx promotion
B-M is on a UK and European brief for Rotarix

Then again on the BM website we have
Jan 2006
With Novartis(please note that they are a key player in this particular industry p.2) and Pfizer, (note page sponsor)

and Jan 2005
With GSK (of whom Mr Earnshaw is a former Head of EU political Affairs) and Novatis

and a bit of previous dodgy BM dealings in Biotech lobbying.

What happened this week

Kathy Sinnott MEP / Irish, Independent, in the same group as UKIP in the European Parliament stood up in committe during the debate on the subject and demanded to know how it was that a lobbyist was providing independent expert advice. Consternation and muttering in Committee, but no firm answers. She was chased out of the room by the Commission official demanding to know what was going on.

Earnshaw wrote to her that evening, copying it to the senior officials on the Environment Committee, This letter is long but I include it in its entirety to make sure there can be no claims that I am misrepresenting his position.

164 rue Victor Hugo,



Tel: 0475 654854

Fax: 02 732 8534

Ms Kathy Sinnott, MEP,

European Parliament



13 September 2006

Dear Ms Sinnott,

Several Members have contacted me today to let me know that you referred to me and the report I drafted for Parliament on the advanced therapies proposal during this morning’s meeting of the Environment Committee. I understand that you inferred that this was some kind of clandestine lobbying.

These are the facts:

I was appointed as an expert health and pharmaceutical policy adviser to the Environment committee earlier this year. This followed an open call for tenders (on the internet) and the submission of my full curriculum vitae, list of publications, and other details about my professional experience, including my current working commitments. I would be delighted to provide you with a copy of my credentials as submitted to Parliament. Alternatively, you or any Member can ask Parliament’s secretariat for this.

My report on the advanced therapies proposal was completed at the end of March 2006, and appeared on the committee website subsequently. It is available for anyone to read, as is a second report on the same proposal produced by another expert.

You will note, should you read my report, that it argues the following points, among others (for your convenience I have emphasized in bold the key aspects):

Parliament should “ensure that the privacy of patients receiving gene, cell and tissue therapy products has been sufficiently taken into account by the Commission and that the planned Commission guidelines, once adopted, will do the same.” (p. 16, para 39)
“it is surprising that the explanatory memorandum for the proposal says remarkably little (one short paragraph) about traceability and privacy. It is also remarkable that there is only one passing reference (at the end of recital 20) in the Commission’s proposal to the requirements of directive 95/46 on the protection of individuals with regard to the processing of personal data and the free movement of such data.” (p. 16, para 40)
“Parliament should consider whether it is realistic and/or desirable to establish such a publicly-run and possibly pan-European traceability system for gene, cell and tissue therapy products rather than the potentially fragmented compromise that the Commission has proposed.” (p.16, para 42)
“The proposal does not refer to what would happen to traceability data in the eventuality of a hospital, institution or private practice where the product is used closing. This should be rectified.” (p. 17, para 43)
Crucially, the report argues that “Parliament will no doubt wish to consider whether it is appropriate for access to medicinal products developed for patients with at best intractable and most often incurable illnesses to be denied in parts of the European Union, despite those products having been authorized by the EMEA and being in use elsewhere in the Union. It is one thing to enshrine this kind of restriction in the context of legislation on the quality and safety of cells (as in directive 2004/23); allowing patients in Europe to be denied access to products resulting from such technologies, whilst others benefit, is going a step further” (p. 18, para 45)
Associated with the foregoing, the report also points out that:

“Neither is it sufficient to suggest that patients may travel from one member state to another to gain access to treatment: ethically restrictive member states would presumably prevent reimbursement of such treatment also. Hence, access would be limited to those patients who were able to afford treatment themselves, those with supportive families and friends, and those able to travel. The non-Europe in bio-ethics therefore runs the risk of opening new social divisions, and of undermining the idea of social solidarity in access to healthcare.” (p. 18, para 46)
And, in paragraph 47 it is argued that

“It will be important for Parliament and Council to debate this issue again as in this case the non-Europe in ethics will cut directly across patient access to authorized medicinal products. At the very least, Parliament and Council should take political responsibility for confirming that the logic of non-Europe should apply in the case of this legislation as it does for the human cells and tissues directive.”

On xenogeneic products, the report points out that: “Some religious organizations have suggested excluding xenogeneic products entirely from this proposal. Were xenogeneic products to be excluded the current fragmentation of regulatory approaches in Europe would be perpetuated and the shared scientific and assessment resources of the EMEA would be prevented from contributing to patient safety. Nobody doubts that risks exist in the use of xenogeneic cell and tissue products. However, excluding such products from this proposal would succeed only in making their regulation and assessment less stringent and most likely lead to patients in some member states being exposed to risks that otherwise could be avoided.” (p. 19, para 51)

The report adds that “it is for Parliament and Council to review the ethical issues surrounding xenogeneic products, in particular with a view to taking political responsibility for the possibility that access to potentially life-saving therapies could be denied in parts of Europe, on the grounds of ethical unease.” (p. 19, para 52)

The issues addressed in my report for the committee are important (as demonstrated by the briefest of glances at the extracts above). You and some of your colleagues may disagree with many of the points made. That is in the nature of independent advice – and why Parliament seeks a range of independent experts. I challenge you, however, to identify in my report any of the main issues I have addressed which correspond with the lobbying efforts conducted by the pharmaceutical and biotechnology industries, NGOs or others.

In fact, as far as I can tell, industry lobbying has tended to focus on relative detail (the composition of the CAT, incentives, for example) rather than on addressing the main issues involved, namely, those related to stem cell research and the future fragmentation of Europe as a result of member state governments being able to deny patients in Europe access to new cures and treatments.

Indeed, within Parliament, it appears that the needs of European patients suffering from often incurable and intractable illnesses are being sacrificed due to an exaggerated and ultimately religious obsession to oppose stem cell and other medical research. I freely admit that I disagree with the view that religious and other transient beliefs should over-ride the needs of European patients for new treatments and new cures. My position corresponds, I believe, with the view of the large number of European patients, whose voice is frequently not heard.

While the proposal’s legal base has quite rightly been questioned, partly as a result of the issues raised in my report, neither the rapporteur nor the Environment Committee has questioned significantly the logic – or political implications - of a Europe within which some patients will have access to new cures and treatments, and others will not. This is unfortunate, to say the least.

I understand that today you also referred to Burson-Marsteller, with whom I work three days per week in addition to my other work, such as teaching at the College of Europe, Bruges. Burson-Marsteller is a leading public affairs consultancy in Brussels which complies entirely with relevant codes of conduct as well as having extremely strict internal rules which require absolute transparency in all communications with the institutions and others. In every communication Burson-Marsteller consultants make with the institutions on behalf of a client (whether face to face, in letter, e:mail or by phone), it is always declared who is the client, and the client is acknowledged in all Burson-Marsteller work.

The report I drafted for the Environment Committee is not connected with my work for Burson Marsteller. Neither is it lobbying. The report I drafted was produced for the Committee and sought to take account (as you will see when you read it) of the committee’s likely concerns (it addresses in detail, for example, commitology) based on my knowledge of the Committee, and its work on pharmaceutical policy, over the last 20 years. It is worth adding that I have never lobbied on behalf of a pharmaceutical company or other interest on this legislation and neither has Burson-Marsteller advised clients on it either.

Finally, no-one is “independent”: people work for businesses, NGOs, governments, political parties, etc. That is why it is important to be transparent, as I was, about credentials and experience, and why Members may either accept or reject my arguments, on their merits. Again, that is the reason Parliament has a range of experts to provide advice that the committee may either accept or ignore. Also, ultimately, politicians decide, not experts.

In future, I would be obliged if you would have the courtesy to contact me directly, preferably before attacking me, should you have any questions about my work.

Yours sincerely,

David Earnshaw

cc. ENVI Committee chair and Vice chairs

ENVI Coordinators

ENVI Committee Secretariat

M Mikolasik, D Roth Behrendt, F Ries, H Breyer

This letter is revealing in that it flags up where he has had influence, but also because one or two lines are priceless.

"It is worth adding that I have never lobbied on behalf of a pharmaceutical company or other interest on this legislation and neither has Burson-Marsteller advised clients on it either".

Which either means he is lying or incompetent, but looking at BM's website again on their hot topics for July we see

Advanced Therapies Regulation

The European Parliament and Council of Ministers are currently considering a Commission proposal for a Regulation on advanced therapy products referring to highly innovative medical products based on genes (gene therapy), cells (cell therapy) or tissues (tissue engineering). The objective of the Regulation is to improve patients' safe access to advanced therapies by creating a centralised authorisation system in Europe, effectively harmonising market access and ensuring the free movement for these products. Of particular interest is that the proposed Regulation would leave to the individual Member State the decision on the use or prohibition of any type of cells (such as embryonic stem cells) due to the ethical issues raised by some countries on the use of human and/or animal cells in some advanced therapy products. Industry is now recognizing that application of the “subsidiarity” principle in this way will allow some EU countries to prevent the sale, use or supply of these products thereby fragmenting the single market and casting doubt over the integrity of a single European marketing authorization. Patient groups as well are also starting to recognise that the proposal may fail to consider the needs of patients across Europe and the future potential of advanced therapies for curing illness through medical innovation. Ultimately, this is not only a clash between national and EU competency, but also a clash of values - innovation and the value of medical research versus concerns over the ethical and religious implications of some kinds of medical research. The Parliament is expected to complete its first reading by September 2006.

Suggesting that he is either fibbing or letting down his clients, and clearly rattled. After all his cv does state

"2002 - Burson Marsteller, Brussels (part time)- Managing Director,

directing and providing EU healthcare and pharmaceutical-related policy consultancy for several major pharmaceutical companies, trade associations and professional/medical organisations".

The other good bit about his letter is his comment, "I freely admit that I disagree with the view that religious and other transient beliefs should over-ride the needs of European patients for new treatments and new cures".

New Labour, his own chosen belief system is obviously non transient, whereas Christianity is just a 2000 year flash in the pan. Not sure if Bursom Marsteller really want to express views that would so inflame both Isla and Christianity,not to mention Hinduism, Shinto and Bhuddism but there you go, maybe that is their policy.

I suppose by non transient he means earning lots of cash, so maybe he has a point.

The final point is that the next day after the revelations, that is yesterday, the regulation was thrown out. Costing his clients hundreds of millions of pounds in lost revenue while the Parliament has to start all over again.

Naturally the MEPs who voted it down are not giving credit to Mrs Sinnott, as gifting any credit to the Ind/Dem Group is unacceptable in Brussels, what accept that the swivel eyed bunch can be effective, never.

However the leader of the socialist group said something that I will remember in my aged dotage. Dagmar Roth-Berendt says the Burson Marsteller angle did not influence the vote – the Socialists, who voted against the report en bloc, did not like for “ethical” reasons.

That is a first.

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