Monday 22 September 2014

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The pharmaceutical industry against patients, doctors and pharmacists

Posted by on 18/09/14

Joint letters with like-minded organisations are never easy to write, even among friends. Each organisation wants to add its own nuance.Different organisations may have different rules for sign-off on final drafts, and amendments can ping-pong from one to the other. I’ve been there.

Sometimes, however, an issue is so important and clear that a joint position is agreed and action taken in a very short time – as in the case of the 30 health-care organisations that have written to Mr Juncker to oppose the proposal to transfer responsibility for medicines, medical devices and health technology from DG Sanco to DG Enterprise.

And not just any organisations: the signatories include the European representative associations of national organisations of doctors, pharmacists, hospital physicians, hospital pharmacists, health mutuals and health insurance funds, hospital associations, social security funds, cancer leagues, heart foundations, medical bulletins, patients, the elderly, consumers and many others. Offhand, I cannot think of any major European healthcare representative voice that has not signed up – well, the pharmaceutical industry, perhaps, but they have their own agenda.

The editor-in-chief of the British Medical Journal, Fiona Godlee, has also written a joint letter with the review Prescrire, in the same sense.

I don’t think I have ever seen such a wide and immediate agreement between such a diverse range of professionals, patients and consumers on one issue. This is the united voice of the European healthcare sector. Will Mr Juncker listen?

The decision to make the transfer from health to the industry DG seems to have been at the demand of the European pharmaceutical industry. According to an article in Scrip on 12th September:
EFPIA said that commission president-elect Jean-Claude Juncker had “taken on our views and put together all units that are relevant for our business in Europe”. These, it said, were previously spread over three directorates general, SANCO (health), MARKT (internal market) and ENTR.

So now we know. We have the industry on one side on this issue and on the other side the entire health care sector – doctors, pharmacists, patients, hospitals, mutualities, sickness and social security funds, consumers etc. The industry claims to play an important role in healthcare and indeed it does but that role is not always positive. END

A bad start for the New Commission

Posted by on 10/09/14

Some years ago, DG Sanco, the health directorate for public health, took over the lead role for medicines and medical devices from DG Enterprise the industry DG, which was responsible for promoting industry, including the pharmaceutical industry. The change was a good one, enabling a clearer focus within the Commission on medicines as an essential element of health policy.

Now in his line-up for the new Commission, Mr Juncker has announced that the units dealing with medicines, medical devices, and health technology will be moved back to DG Enterprise!

In the new Commission, DG Enterprise will be responsible for promoting the European pharmaceutical industry and for Commission policy on medicines and medical devices. Other DGs will have a say, of course, but DG Enterprise will take the lead and will be the main interlocutor with the industry on medicines and medical devices. This is a good day for the pharmaceutical industry, but a bad day for public health. The industry has great influence across a wide range of government policies but typically rather more influence on industry departments – and this is not to imply any impropriety on the part of DG Enterprise.

One DG should not combine the lead role for medicines policy with the lead role for the promotion of the pharmaceutical industry. This is not the way to achieve clarity in public health policy. The difficult task of balancing the interests of public health and the (legitimate) interests of the pharmaceutical industry should not take place within the one DG (and should not be well hidden from public scrutiny) .

There is also the difficulty of ensuring the right mix of skills within the one unit or DG – combining specialists on public health with expertise on industrial promotion.

This was how the change was announced:

Units SANCO B2 (Health Technology and Cosmetics), SANCO D5 (Medicinal Products – Authorisations, European Medicines Agency) and SANCO D6 (Medical Products – Quality, Safety and Efficacy) move from DG Health and Consumers (SANCO) to DG ENTR.

You can see the full announcement here.

The Commissioner–designate for Health and Food Safety is Vytenis Andriukaitis a former Minister for Health in Lithuania – and a surgeon, but he will not have responsibility for medicines, medical devices or health technology. That will be the task of Elżbieta Bieńkowska, a former Deputy Prime Minister of Poland, who is the Commissioner–designate for Internal Market, Industry, Entrepreneurship and SMEs, to give her full title.

The new Commission-designate must be approved by the European Parliament and I hope there will be strong voices there who think that medicines should be seen first and foremost as a matter of public health policy.

There is still time for the Commission to re-think this appalling decision. END

TTIP: threat or opportunity to public health?

Posted by on 03/09/14
Guest blogpost by By Sascha Marschang, Policy Manager for Health Systems of the European Public Health Alliance (EPHA). It has already been one year since the European Union and the United States began negotiating the “Transatlantic Trade and Investment Partnership” (TTIP) and international agreement sets out to simplify and enlarge trade between the world’s two biggest [...]

Ombudsman Publishes Commission/EMA Correspondence on Transparency – Part 1

Posted by on 01/09/14

As I mentioned previously the Ombudsman had, on her own initiative, looked into the apparent change of policy on transparency in the European Medicines Agency. She has now published on her website copies of correspondence between the Commission and the EMA on the subject. For those of us who can sometimes get excited about such things, this is exciting and very interesting. You can see the correspondence here.

As readers know, I have complained to the Ombudsman about the refusal of the EMA to give me access to correspondence between the agency and the Commission. I don’t know yet if the documents just published by the Ombudsman would meet the full terms of that request – there is a lot of material here – but I will check.
I also asked for copies of correspondence between the EMA and pharmaceutical industry associations and have complained to the Ombudsman about the refusal to grant me such access.

If we can see correspondence with pharmaceutical industry associations, in addition to the material just published by the Ombudsman, we may have a better understanding of the reasons behind the change of policy in the EMA. END

Lifting the veil in the European Medicines Agency – Part 2

Posted by on 01/09/14

In my previous blog, I covered the apparent change of policy on transparency in the EMA and told how I requested access to various documents in the agency. You can see their letter of refusal again here.

So, I appealed the refusal at some length (see here ). The response (attached) came within the time prescribed for such things but was again negative.

More reasons were given this time, including an explanation of why, in the EMA’s view, release of the documents at that time would undermine their decision making procedures, as in the following extract:

The disclosure of such information prior to the finalisation of the Policy may lead to unnecessary external pressure from various stakeholders that might compromise the final steps of the process and all Agency’s efforts made in the last 12 months to strike a balance between proactive data disclosure,the absolute need to protect personal data and the concerns relating to the protection of commercially confidential information..

The agency also referred to the administrative and other problems involved in disclosing the more than a thousand responses to the earlier public consultation on transparency.

Well, I did not ask for access to every submission but only to communications to and from the Commission and to and from pharmaceutical industry associations. I assume there were a lot less than a thousand of these.

Anyway, why not publish all responses to public consultations? There would be little administrative burden attached to putting in place a policy of publishing on a website a copy of all submissions on matters of public policy as soon as they are received (subject to limited exceptions for personal privacy and genuine commercial confidentiality).

More to the point I could not accept the argument that disclosure of the documents I requested would “seriously undermine” the decision-making process of the agency.

I have referred the refusal to the Ombudsman, and she will now consider it under the rules and principles that guide her work. More later… END

In praise of Anne Glover

Posted by on 26/08/14
As activists along the halls of the Mundo-B building smell blood and put their PR machines into high gear, a bit of rationality should be restored to the question of the role of the Chief Scientific Adviser to the President of the European Commission. It is high time to acknowledge the great work that Dr Anne Glover has done. In short, high-level advice must be given to the president in confidence by a single individual.

Life with Disability: “I am not Feeble-minded, I just Can’t Hear You Well”

Posted by on 20/07/14

Article by: Jelena Đorić, Hrvoje Nimac, Haris Dedović
Edited by: Ana Alibegova & Stefan Alijevikj

“When I go to the counter in some institution, I have to read the lips of the officer behind the counter because I cannot hear the voice through the glass. Sometimes I do not understand so I have to ask same things several times. Then this person becomes upset and starts yelling at me saying word by word, as if I am feeble-minded. Then I have to tell them: Sorry, I’m not stupid, I just can’t hear very well”.  This is how Sandra Peshevska-Mickovska, a passionate painter and a member of  the Association of Students and Youth with Disabilities portrays an unusual situation from the everyday life of a person with disability in Macedonia. Together with Daniela Stojanovska – Djingovska, the President of the Association of Students and Youth with Dissabilities, they present their organizational activities, explain the challenges they are facing, discuss the inclusion of the disabled people in Macedonia, and send a message that being disabled does not require a special treatment or over-emotionalizing, but equal rights as any other citizen of the country.

M!: Tell us something about your association. What are the activities you work on?

Daniela: Our association started working in 2002 and at the beginning was registered as an “association of students”, however, some time later, we re-registered and became “youth association”, being able to also include other young people with physical difficulties. The association has around 150 members and while most of them are people with disabilities, we also have 10-20 per cent of people without disabilities as we are an inclusive organization.

Regarding activities, first, there is the promotion and implementation of inclusion of people with disabilities, but in addition, we are working on the realization of rights, equality and on the correction of system errors that we have in Macedonia. Essentially, we are trying to remove all barriers  for people with disabilities, in order to engage them more easily in the educational processes.

M!: Do you cooperate with the authorities in Macedonia?

Daniela: When it comes to financing, as an association we are not getting anything from the present government and we have not gotten anything from any of the preceding governments either. We are funded strictly by foreign donations. Since we operate as a service and we are unique in this regard, we have tried in the past to get some funding from the authorities, but it was all in vain. One thing I can commend is that we have a good cooperation with the governments regarding creation of new laws. In 2008 an Act was adopted that enabled people with disabilities to be free of fee payment for enrolling to higher educational institutions. This resulted with increased number of people with disabilities going to college. And on a local level, in the city of Skopje, the transportation for the people with movement difficulties has been solved.

The elections are over. Now what?

Posted by on 08/07/14

Whitehouse Consultancy Chairman, Chris Whitehouse, uses his column in Natural Products News to predict a big fight ahead to defend consumer access to safe and popular higher potency food supplements.

By the time this article is published an entirely new European Parliament will have met for the very first time. These are the men and women who, for the next five years, will have an enormous influence on the development of laws that affect everyday life throughout the 28 EU Member States.

As with every legislature after an election, a significant proportion of these Members of the European Parliament (MEPs) will be new to their role; indeed, given that the European Parliament tends to attract less mainstream parties and individuals, it is likely that a great number of these new MEPs will be entirely new to elected office. Smooth, experienced, cynical professional politicians they are not and this is precisely why it is crucial that the natural products industry start engaging with them now.

A few big issues will dominate the new parliament – how to solve the Eurozone crisis, for example – and on these we can expect the new MEPs to have firm, well-informed views. But, on the myriad of relatively small problems that the European Parliament must deal with, new parliamentarians are often, in the nicest possible sense, entirely clueless. They may have a philosophical position that informs their view or they may have some hazy ideas on a particular topic but much of the time they will merely follow the lead set for them by the political group to which they belong.

Here is both great danger and great opportunity for the natural products sector. The danger lies in the fact that every big business and lobbying group knows that this cohort of new MEPs are open-minded – and open to influence.

Groups such as Food Supplements Europe (FSE), the lobbying organisation funded by multinational supplement corporations, will be moving fast to press MEPs on the supposed advantages of setting low maximum permitted levels in vitamin and mineral supplements at the earliest opportunity. That this would force consumers to give up safe, well-established higher potency products is something that FSE would not of course admit to these MEPs and, as they are so new and on ground with which they are unfamiliar, it cannot be expected that MEPs would automatically know this.

But it is a time for opportunities too. The natural products sector can take the initiative themselves and it does not have to be expensive or time-consuming.

Consumers for Health Choice, the campaigning group which I serve as Director of Strategy, is starting its engagement now. Over the summer we will be encouraging our supporters to meet their newly-elected MEPs here in the UK to speak to them about why preserving consumer choice in natural health products is so important. We will be working closely with other supportive groups to ensure that small retailers in the sector are able to put their points to MEPs at the right time.

CHC will also be arranging a trip to Brussels at the first opportunity, an expensive but necessary undertaking and a worthwhile investment when it comes to engaging with new MEPs. We need your support to ensure that we can get to the heart of Europe and make sure that big business don’t have it all its own way – you can help by going to www.consumersforhealthchoice.com and donating.

Right now in Brussels there are a huge number of new MEPs with little or no knowledge of your concerns and your sector, but with enormous power to change it. Either the other side puts its spin on the natural products industry or we make that effort now. We may not get another chance – it is in your hands.

This article first appeared in Natural Products News.

The Whitehouse Consultancy is Europe’s leading public affairs agency for the specialist health product sector. The agency’s clients include Consumers for Health Choice and the European Specialist Sports Nutrition Alliance and a wide range of specialist food product manufacturers and distributors.

ESSNA Vice-Chair Martin Cheifetz interviewed by BBC Radio Kent

Posted by on 01/07/14

ESSNA Vice-Chair Martin Cheifetz has appeared on BBC Radio Kent’s Breakfast show, representing ESSNA, on Monday 30th June just after 8am. Mr Cheifetz, who was interviewed by John Warnett and appeared alongside a number of other experts, discussed the sports nutrition industry’s concerns around the industrial chemical dinitrophenol (DNP), which the radio show was able to buy as an illegal weight loss pill as part of its investigation.

Mr Cheifetz made the clear distinction between DNP and sports supplements, reiterating that DNP is not a sports nutrition product, but an industrial chemical that is not fit for human consumption, and that it is mostly sold illegally over the internet. He added that sanctions do exist for rogue traders selling the chemical illegally, and that stricter regulation is unnecessary – what is needed is for authorities to ensure that the existing rules are complied with.

Mr Cheifetz’s interview can be accessed via the link below until 7th July 2014:

http://www.bbc.co.uk/programmes/p0213fgz

The DNP feature starts at 2 hours and 7 minutes.

ESSNA is the voice of the sports nutrition industry in dialogue with regulators, policy makers, the media and consumers. Its work focuses on campaigning in favour of proportionate EU legislation which does not adversely affect the sports nutrition sector, as well as monitoring and reporting irresponsible companies which flout EU law for commercial advantage and may put consumers at potential risk from dangerous products.

ESSNA is a client of European leading specialist food sector public affairs agency, The Whitehouse Consultancy. This post first appeared on the ESSNA website.

 

Das Rauchen in der Europäischen Union

Posted by on 29/06/14

Rauchen ist ungesund. Und teuer. Es tötet jährlich hunderttausende Menschen in der Europäischen Union und belastet das Gesundheitssystem mit Milliarden Euro zusätzlich. Aber sollte der Staat deshalb eingreifen, mehr reglementieren, Tabakwerbung komplett verbieten? Nein. Er sollte darauf setzen, seine Bürger noch besser über die Gefahren des Rauchens zu informieren statt sie zu bevormunden.

In einer freiheitlichen Gesellschaft wie es sie zum Glück in Deutschland gibt, dürfen und sollen Menschen selbst entscheiden, was sie tun. Sie haben eine Wahlfreiheit. Sie können rauchen – oder nicht. Sie können trinken – oder nicht. Sie können Süßigkeiten und Fast Food essen – oder nicht. Sie können allerlei Dinge tun, die ihnen Freude bereiten, aber in gewisser Hinsicht auch schaden.

Wer Tabakwerbung verbieten will, muss dementsprechend auch so konsequent sein, Werbung für viele andere Dinge zu verbannen. Wo fängt man an, wo hört man auf? Und vor allem: Was steht am Ende? Garantiert keine freiheitliche Grundordnung mehr. Deshalb: mehr aufklären, mehr informieren und nicht nur verbieten.

Obesity in Europe – Facts & Solutions

Posted by on 27/06/14

According to WHO, obesity is one of the greatest public health challenges of the 21st century. Ever since the 1980s, the number of obese people in the WHO European Regions has been on the rise, and increasing at an alarmingly fast rate.

Excess weight causes various physical disabilities and has its fair share in the development of diseases like cancer, cardiovascular and diabetes – all of which directly impact health budgets of European countries. In the following, we present the current rates of obesity in Europe, the countries for which it’s a serious challenge and what measures are taken to cut down the obesity rate on the continent.

(more...)

Superbugs: How diagnostics can help doctors reduce over-prescription of antibiotics

Posted by on 18/06/14
  A few years ago I was attending a conference on biologics manufacturing and the keynote speaker said their industry was lagging in implementing modern microbiological tools whereas the beer industry was way ahead. I was glad there were no clinical microbiologists in the room! Molecular methods have been used for the discovery of several [...]

Obesity: a simple step for the new Commission to take

Posted by on 10/06/14

The decision by both the European and the US authorities to approve the use of the new sweetener Advantame adds a new weapon to the arsenal of those seeking to tackle obesity.

For many years now there have been sustained customer trends to choose low calorie products to the extent that for the main cola brands the low calorie product now outsells the full sugar version in some countries.

Much is made by policy-makers and nutritionists about the complexity of changing public behavior in food choices, but in this area one approach screams out for action. Health authorities and policy-makers in all 28 EU member states should give the same, clear and consistent message. If consumers are going to choose a sweetened beverage they should consider a low calorie version. This could deliver a rapid and substantial improvement in public health without the need for legislation and with almost no expenditure. All it would take is clear thinking and courage to stand by the robust risk assessment processes of the European Food Safety Authority that has concluded time and time again that key sweeteners are safe and pose no real risks for consumers.

Let’s hope the new Commissioner of DG SANCO when appointed has the commonsense to take this easy step.

The Whitehouse Consultancy is Europe’s leading public affairs agency for the specialist health product sector. The agency’s clients include Consumers for Health Choice and the European Specialist Sports Nutrition Alliance and a wide range of specialist food product manufacturers and distributors.

Letter to EMA from Glenis Willmott MEP

Posted by on 09/06/14

Good news. Glenis Willmott MEP has written an open letter to the European Medicines Agency to express her concern about changes to its transparency policy.

The medical device industry: keeping face with patients

Posted by on 06/06/14
For a 3rd year in a row PatientView has published its study on “The corporate reputation of the medical device industry – from the patient perspective”. As in the past the reputation of the medical device industry and specific companies are measured by hundreds of patient groups from all over the world. In the latest [...]

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