Friday 30 January 2015

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Health & Consumers


A herbicide spray to keep the bio-tech industry at bay? RIP traditional European agriculture

Posted by on 15/01/15

By Kathleen Garnett

Ever since the first boff in a lab profited from fiddling around with the genetic make-up of plants European agriculture has been at the mercy of the big corporations. Not unlike the pests GMO products are said to repel the bio-tech industry has been swarming all over the treasure chest that is European agriculture determined to find a crack in the armour and squeeze in. Those holding patents to GMO seeds have launched a relentless campaign to get their products approved for use across the EU. For fifteen years the EU put up a good fight but it was clearly no match for the ants. As long as there was sugar in the chest they would find a way to get in and find it they did this week when the European Parliament approved new measures that have effectively opened up the treasure chest and allowed the pest to swarm in.

The crack in the armour? The bio-tech industry’s best tactic was always going to be to focus on science rather than on need or quality. All other arguments in favour of GMO products are weak. Very weak in fact. Few are convinced that GMO products add quality to food. Few believe that commercialising GMO products leads to diversification in agriculture. Few believe that GMO products give European farmers more autonomy over how they manage their farms. Few believe that GMO products offer gourmet tastes and experience. Most of all few really believe that Europe actually needs GMO foods. Europe has food surpluses and a Russian trade embargo.

Forget, for a moment, the whole debate about whether GMO food is or is not safe to eat, whether it will or will not destroy Europe’s eco-system or whether GMO food is more nutritious than mother nature’s bounty (even though the jury is still out on that) … the reality is Europe does not need GMO food. There is no gap in the market that needs plugging. Europe is not suffering from famine. It has other means to control pests, other than perhaps the bio-tech industry itself. It has enough traditional seed varieties that are capable of feeding the population. Nor is there a particularly strong yearning in Europe for GMO food.

In the fifteen or so years since the bio-tech industry has been lobbying Europe to get their products approved for use European consumers have not exactly been clamouring for GMO produce. Europe’s top chefs are hardly frothing at the mouth or singing with joy that the day is nigh when they can finally offer their sophisticated clients a GMO parfait. Supermarkets are not offering pre-booking for the first batch of GMO maize, tomatoes or soya beans to hit the shelves some time next year. This is because pretty much everyone in Europe has figured out what the EU has singularly failed to – no one in Europe particularly wants to eat GMO food, buy GMO food or serve GMO food to their family or friends. Few, other than some random scientists who insist they know more than the rest of us, wish to see European fields transformed into a form of mono-agriculture growing crops that are surplus to requirement.

Sadly, European decision makers – in the Commission, in the Council and in the European Parliament took none of these considerations into account and fell for the “sound” science argument hook, line and sinker. As though all decisions on food should be based on one variable and one variable only – science. Food science is an evolving science and has hardly proven itself worthy of the adjective “sound” in recent years. Other considerations barely factored in to their decision making process leading many to believe that the EU has become frigid with fright at the sight of a scientist in a white coat.

So star-struck by the sound science argument have EU decision-makers become they are even prepared to compromise one of the founding principles of the European Union – a level playing field for the single market. The new measures are a fudge that is going to lead to the weakening not the strengthening of the single European market – and all because the bio-tech industry got a certificate saying that GMO’s are “safe” to eat. This week marked the point of no return for European agriculture. The point when the ants brow-beat Europe’s decision-makers, prised open the chest and got in.

It would be refreshing if for once European decision-makes were to listen to what European consumers are saying rather than being brow beaten by the bio-industry. This week’s development does not auger well for the TTIP and the regulatory convergence in food safety. Expect European food and agriculture to become even more dumbed down within the coming months. As with GMO so with the TTIP. Many in Europe have made is clear that they do not want regulatory convergence of food but based on this week’s development it is unlikely anyone in Brussels is listening to ordinary consumers anyway.

Last summer’s flourishing fields may well be the last anyone remembers when European soil was truly free from commercial GMO crops – unless that it someone can develop a herbicide capable of repelling the bio-tech industry from European soil.


Deutschlands Krankenhausreform

Posted by on 07/12/14

Auf dem Papier ist die Krankenhausreform wirklich gelungen. Die Ziele, überflüssige Betten abzubauen, unnötige Operationen zu vermeiden und im Dienst der Patient mehr Qualität ins System zu bringen, sind selbstverständlich richtig. Mehr noch: überfällig. Auch der Ansatz, dass eine Umstrukturierung nur gelingen kann, wenn man in das Neue investiert, gehört bei politischen Reformen nicht immer zur Selbstverständlichkeit. Immerhin soll eine Milliarde Euro in neue Strukturen fließen. Das Problem der mangelnden Krankenhausinvestitionen durch die Länder aber bleibt bestehen. Wie gut der Plan wirklich ist, wird sich erst bei der Umsetzung zeigen. Der Widerstand der Kliniken gegen die Bezahlung nach Qualität ist enorm. Dass man bei der Qualitätsbeurteilung ähnlich wie bei der Verteilung der Gelder an Krankenkassen das Alter und den Krankheitszustand der Patienten berücksichtigt, ist ein schwieriges Unterfangen. Die Gefahr, dass die Kliniken ihre Patienten dennoch nach Risiken selektieren, bleibt groß. Und dann wären wieder einmal die Schwächsten im System die Verlierer.

New study warns of sugar content in children’s juice drinks

Posted by on 24/11/14

Political Consultant Sam Blainey highlights a new report on sugar levels in children’s drinks.

To read Sam’s article, please click here.

The Whitehouse Consultancy is one of Europe’s leading public affairs and communications agencies.

Access to Documents – Another Thrilling Episode

Posted by on 27/10/14
By Jim I requested access to documents on the dealings between DG Enterprise and pharmaceutical industry associations. I was not told that they could disclose the documents in part by removing any bit that meets any of the exceptions for disclosure such as the protection of privacy. This is a route I have taken in the appeal.

It’s Not All Bad News

Posted by on 24/10/14

In telling the Parliament on Wednesday that the units on medicines and pharmaceutical products will stay with DG Sanco Mr Juncker added “..I agree with you that medicines are not goods like any other”. I couldn’t have put it better myself.

This is good news and thanks to those who worked to achieve it, especially the European Parliament.

The new “DG Enterprise” will play an important role in internal discussions in the Commission on policies on food safety, medicines and medical devices because of its responsibility for industrial policy in these areas. There is nothing inherently wrong in this. I have spent a lot of time opposing the views of DG Enterprise on specific points but at national and EU level it is right  to take industrial policy (and the views of industry) into account in overall policy making. What is important is to achieve the right balance, and that would have been impossible if the same DG had been responsible for medicines and for promoting the pharmaceutical industry. In my opinion, that balance was skewed in the past when the two responsibilities were combined – I’m talking about you, Mr Bangemann.

In speaking to the Parliament Mr Juncker went on to say “ The relevant policy will be developed jointly by Vytenis Andriukaitis and by Elżbieta Bieńkowska, who showed her incredible talents in her hearing”. The word “jointly’ may mean, as I hope it does, simply a continuation of the a long standing agreement for close coordination on medicines (and food) policy between the two DGs.

There will, however, be a “gatekeeper’ in the new Commission in the form of the First Vice-President, Mr Timmermans, with responsibility for Better Regulation. There is also a strong political tide in favour of a less “interventionist” Commission. The merits of that can be debated but whatever happens it is still better that medicines and medical devices stay within the Health DG.

By the way, some members of DG Enterprise felt that my blogs were accusing them of favouring the industry over patient safety, but I meant nothing of the sort. Faced with a choice between the safety of a medicine and the demands of a pharmaceutical company I am sure they would all opt for safety. My concern was for achieving the right balance in the overall policy on medicines and health. There are important decisions to be made on such issues as transparency, relations between industry and health care providers, the evidence base for clinical decisions, and TTIP, to name just a few. It is too much to expect that the right balance can be achieved on such issues by giving one DG responsibility for medicines and for promoting the pharmaceutical industry.

The Commission will do better with a strong and well resourced internal voice for health.  With the units on medicines and medical devices working alongside its other health units, DG Sanco can be that voice, and I hope it will.END

Report highlights Vitamin D deficiency among children

Posted by on 23/10/14

A report published by the charity Vitamin D Mission earlier this week revealed that, alarmingly, the number of children with vitamin D deficiency has soared by more than 200% in the past five years, with 4,638 under-16s admitted to hospital with vitamin D deficiency and rickets. The cause of this has been attributed to the lack of awareness amongst parents of the importance of vitamin D in ensuring good health. We also heard this week that a similar lack of awareness amongst parents was said to be a contributory factor toward levels of childhood obesity, with some parents apparently oblivious to the fact that their children are overweight and unaware of the importance of encouraging their child to have a balanced diet and adequate exercise.

Upon reading these reports, your initial reaction may be similar to mine – how on earth could parents not realise something which, when set out so logically in a newspaper article, appears so obvious? But then, I would ask any of you to consider the last time you just stopped and thought about the need to take vitamin D supplements or – again, independent of the media’s influence – whether you are of a healthy weight?

The truth is, we all have busy lives. On top of that, many of us may live or have grown up in an environment where health issues such as being overweight are the norm. External guidance is important in helping to remind and educate us – and our families -  about issues that may otherwise not cross our minds. Even simply raising awareness of what is a healthy weight or what vitamins children need when growing up can be very effective.

National Obesity Awareness Week (NOAW), which the Whitehouse Consultancy assists in running, had a huge impact in this, its first year, highlighting the gravity of the obesity epidemic which will escalate if we don’t do more to tackle how children and adult live increasingly unhealthy lives.

Moreover, the messages disseminated in dedicated awareness raising campaigns like NOAW can have multiple benefits; a greater uptake of physical activity among children would not only tackle obesity but also do much to ensure children are getting a greater amount of natural vitamin D from sunlight.

What is clear is that the lack of awareness around these and other public health issues appears to be the common theme underlying widespread incidences of poor public health. The important role of awareness raising campaigns in addressing this cannot be overstated.

The Whitehouse Consultancy is one of Europe’s leading public affairs and communications agencies, providing support to NOAW for the past few years. Its range of specialist services for the food sector can be found here.

Personal and Private? Correspondence between DG Enterprise and the Pharmaceutical Industry.

Posted by on 19/10/14

Citing Regulation (EC) 1049/2001, I asked last month for access to the following documents:

All communications in any form, and notes or records in any form of communications between DG Enterprise and any pharmaceutical Industry association concerning the policy, draft policy or decision making process of the European Medicines Agency on the issue of access to clinical trial results, after the closing of a public consultation on that issue on 30th September 2013 and before 21st May 2014’

I got a reply on 17th October with a copy of just 6 (yes, six) documents.

Three of the documents were requests to individual officials in DG Enterprise to fill in survey questionnaires relating to access to clinical trial data – one survey with five questions, and one with seven questions sent to two different officials on the same day. The questions and the answers, if any, were not included.

The fourth and fifth documents were a copy of an invitation to join an EFPIA webinar on access to clinical trial data, and a summary of the discussions at the webinar.

The sixth was an e-mail to DG Enterprise dated 10th March 2014. It contained (part of) a letter from the US and EU pharmaceutical associations to four DGs, the EMA, FDA, and US Trade Representative. The letter contained detailed suggestions for the EMA transparency policy and argued that the same principles be applied when implementing the regulation revising the Clinical Trials Directives. The letter also requested the Commission’s assistance in interpreting transparency Recital 20A of the new regulation in the light of other provisions dealing with commercial confidentiality.

And that’s it. According to the letter from DG Enterprise, disclosure of all other dealings between DG Enterprise and the pharmaceutical industry “would undermine the privacy and the integrity of the individual” and was therefore subject to the exceptions in Regulation 1049/2001. This applies across the board, it seems, even to things that DG Enterprise might have said to the industry. No documents at all from DG Enterprise were released – apart from a list of the six documents that were released.

In refusing access to these documents DG Enterprise made no reference to Article 4.6 of Regulation 1049/2001, which states “If only parts of the requested document are covered by any of the exceptions, the remaining parts of the document shall be released”.

In response to requests in other areas, correspondence between industry and commission has been released. What is so different about the dealings between DG Enterprise and the pharma industry? Does DG Enterprise have its own interpretation of Regulation 1049/2001? Do most dealings between DG Enterprise and the industry over an eight month period contain such private or personal information that they cannot be disclosed? Can DG Enterprise not tell us even one thing they might have said to the industry over that period? Is this good administrative practice?

DG Enterprise did invite me to put forward arguments that disclosure of these documents, which I have not seen, would NOT undermine the privacy and integrity of (unnamed) individuals. Not an easy task.

Regulation 1049/2001 is part of EU law and confers certain rights on citizens and others. Those rights must be respected, and the regulation must be applied faithfully, by all EU institutions.

This case isn’t over yet.END

Ebola: Scary? Yes! Significant? No!

Posted by on 13/10/14
While the latest outbreak of Ebola is certainly a tragedy, its use by the media and political activists is sadly opportunistic. This crisis should provide the opportunity for us to consider fast-tracking development programmes in these poor West African countries.

Dalligate: Barroso to the exit, with a toxic legacy

Posted by on 13/10/14
Guest blog post by Bart Staes and José Bové October 16th will be the sad and second, silent birthday of the day the European Commission president José Manuel Barroso gave in to manipulations of the Tobacco Industry by sacking Commissioner for Public Health, John Dalli. 700.000 Europeans that die every year of smoking in the EU and one sacked European Commissioner is enough.

Europa Media launches a web platform on EU-China animal health research and cooperation

Posted by on 06/10/14

No matter how distant your professional expertise might be from transboundary animal diseases (TADs), such words as Ebola, Swine Influenza (pig flu), or Avian Influenza (bird flu) periodically circulate daily news across the globe.

Whether it raises (mostly unjustified) concerns and fears among regional communities, or contributes to increased research and vaccine development funding, it is evident that the subject of diseases that can be transmitted from animals to humans is of high significance for all countries.



Urbanization and settling in previously unexplored areas result in closer contacts with animals and emergence of new transmittable viruses. In addition, globalization may cause rapid and wide spread of diseases. Therefore, cooperation across borders is crucial for disease prevention and control and most importantly for raising awareness regarding risks and treatment of infectious animal diseases and zoonoses[1].

Europa Media is a partner in the LinkTADs project – Linking Epidemiology and Laboratory Research on Transboundary Animal Diseases and Zoonoses in EU and China – co-financed under the Seventh Framework Programme of the European Union. The project is aimed at coordinating research on disease control cycle between experts in Europe and China. Coordinated by the Food and Agriculture Organization of the United Nations (FAO), the LinkTADs consortium includes major scientific institutions in the field of animal health, and consists of five European and five Chinese partners.

Within the framework of the LinkTADs project, Europa Media has recently launched the LinkTADs platform – a web platform dedicated specifically to the EU-China animal health research and cooperation. The LinkTADs platform will serve as a bridge for European and Chinese researchers and is aimed at providing an opportunity and common space for international experts to generate new ideas, discuss ongoing initiatives and start joint collaboration.

We are now encouraging all international researchers studying animal diseases to register on the LinkTADs platform in order to discover cooperation and funding opportunities within ongoing projects and existing initiatives, and contribute to discussions on scientific achievements, discoveries or existing gaps in order to jointly elaborate new project ideas in the field of veterinary research.

LinkTADs platform will also be interesting for anyone, who would like to learn more about TADs and zoonoses, as it includes a section of e-resources on animal health and food safety issues in the field of epidemiology and laboratory sciences in the EU and China. The e-resources section is a thematic library of scientific and analytical materials, collected from open sources. Apart from the in-depth expert analysis, many of the entries include detailed explanations of diseases and their impact on animals and humans written in a comprehensible style.

Visit to learn more about EU-China cooperation in detecting common challenges and elaborating joint methods and instruments for animal disease control and disease prevention.

[1] Any disease or infection that is naturally transmissible from vertebrate animals to humans (WHO definition)

Clearing the Air on Transparency Decisions, and on Industry Demands to the Juncker Commission

Posted by on 05/10/14

At the Ombudsman’s recent conference two points were made that seem to contradict things I’ve said here. It is nice to have a blog to answer back.

I said that the Commission had the final say on EMA’s transparency policy (Article 80 of Regulation (EC) No 726/2004 ). I was immediately contradicted by a member of the EMA, who said that the EMA Board took the final decision “with the agreement of the Commission”. Two members of DG Sanco (at least for the present) made the same point in conversation later. Here is my answer, which is based on the correspondence between EMA and Commission, as released by the Ombudsman. In each case I give the relevant page number in the (171 page) pdf document that you can download from here:

Seven weeks after the end of the public consultation on transparency last year, the EMA presented to the Commission a detailed report of the 27 main industry objections to the proposed transparency policy – under the headings of Patient Confidentiality (6 objections), Clinical Trials Format (3), Rules of Engagement (7), Analysis of Results (4), and Legal Aspects (7) – pages 15-29. This seems to have been before the same material was sent to the EMA Board.

At the EMA Board meeting in December, the representative of DG Sanco said that other commission DGs would be affected by the proposal and should be consulted – page 36

At the Board meeting in March 2014, the Commission said that some other parameters should be evaluated “such as interaction with the TRIPS Agreement and the European patent system” – page 93.

On 20-23rd May the draft policy was discussed in detail with DG Sanco – page 127.

On 28th May Dr Rasi wrote to Director General of DG Sanco requesting the Commission’s agreement to the draft new transparency policy that was to be submitted to the EMA Board – page 146.

The draft transparency policy was discussed again in a meeting in June 2014 between the EMA and DGs Sanco, Enterprise (three representatives), Trade, Research and the Legal Service – page 165.

DG Sanco wrote back on 11th June giving their agreement, subject to certain amendments and conditions – page 169.

To claim that the Board takes the final decision is formally, bureaucratically, pedantically correct but, in the real world, wrong.

Also at the Ombudsman’s conference, the Director General of EFPIA said that the industry association had not requested the transfer of responsibilities for medicines to DG Enterprise or any specific DG. Talking to me later, he said that they had asked that the three Commission units dealing with medicines should be brought together into one, but had never specified into which DG they should be put.

So, where did the industry expect the new medicines unit to end up – in DG Fish? In fact they clearly did not have to specify which DG they had in mind.

The industry clearly asked the new Commission to put together the unit dealing with medicines and medicines safety and the unit charged with promoting the pharmaceutical industry. This is exactly what the entire health sector opposes. No one unit or DG should have responsibility for medicines safety/transparency AND responsibility for strengthening the European pharmaceutical industry. Member states do not normally assign responsibility for medicines to the industry ministry and this should not be done at EU level either. END

‘Save the Bees’ Ban: Who is to Blame?

Posted by on 29/09/14
The recent precautionary ban on neonicotinoid pesticides to save the bees has gone badly wrong in less than a year. Oilseed rape crops are being devastated and Member States are now allowing neonics to be used as emergency measures. Farmers and scientists had warned anyone who would listen, but no one in the European Commission was interested in dialogue. Remember the basic maxim: Never outsource policy-making to campaign-driven activists.

The european drug report 2014

Posted by on 28/09/14

Trends and developments presented to LIBE commmitte on the 24th of september by the Director of the EMCCDDA, Wolfgang Götz.The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) raises the attention on the emergence of both new synthetic opioids and hallucinogenic substances which are so powerful that it takes tiny quantities to produce many doses. The fact is that a part of these substances are not even illegal, since they are too new and legislators do not even know them. This challenge requires a quick answer and new funds, otherwise we lose the battle form the start.

The picture emerged from the presentation of the Director of EMCDDA is that of a reduced consumption of heroin but an increase in consumption of new psychoactive substances which were reported to the EU Early Warning System. In 2013 81 new substances were notified, leading to 350 the number of substances monitored. This year 72 new substances were reported and this poses a great pressure on the EU Early Warning System.

The new drugs (new psychoactive substances) can be synthetic or naturally occurring substances that are not controlled under international law, and which have the same effects as controlled drugs. Some of these chemicals are imported from suppliers in China or India and then packaged and sold as ‘legal highs’ in Europe.

In 2013 the EMCDDA was very active. Risk assessments were carried out on two substances in 2013, and on other four by April 2014. The result was that these substances often lead to severe toxicity and also death.

Cannabis is still polarizing the public opinion in Europe, thanks also to the regulatory changes in parts of the United States and Latin America with regard to the ways cannabis is available and controlled. In Europe its consumption is steady, even declining among young people but the situation is not homogeneous among Member States. Still, it represents an important revenue for organized crime groups.

The general European market for illegal drugs is stable: cocaine is most used in southern and western countries and amphetamine are prevalent in northern and eastern countries. Last year Europol noted the dismantling in Belgium of the two largest drug production sites ever found within the European Union, which were capable of rapidly producing large volumes of MDMA (3,4-methylenedioxy-methamphetamine). This is a good sign and EMCDDA is closely working with Europol in the fight against these networks.

Mr. Götz also pointed out the important role that internet plays in the drug market because it links manufacturers, suppliers and retailers. Website-hosting and payment processing services are usually based in different countries. There is a growing use of “dark-nets” for the sale of drugs to dealers and consumers and this represents a huge challenge. In 2013 EMCDDA managed to identify 651 websites which were selling “legal highs” to Europeans.

EMCDDA is cooperating with Europol in order to exchange information and provide joint analysis. With regard to this, a first report on the drug markets in Europe was published. They also cooperate with Cepol by providing them training on drug traffic and with many other partners, such as applicant countries to EU and third countries in general. In response to a question of Josef
Weidenholzer, Mr. Götz outlined that they also cooperate with Iran and that this country has very good researchers but cooperation on the law enforcement side is more difficult.

The drug networks do not have borders and this is an issue which concerns every country in the world, therefore there is the necessity to cooperate with everyone who is active in the fight of drug consumption and drug traffic.

In the end, the President of EMCDDA declared that the Centre needs more funds but the trend is that of cutting of funds available for it. In 2014 they experienced a 5% cut of the budget compared to the previous year. He outlined that he is aware of the economic crisis but we deal with organized crime networks which are seeing their profits growing and Europe cannot afford to reduce its efforts in fighting these criminals.

The presentation was followed by the intervention of Michał Boni who raised the problem of standardization of all sources of information, since data coming from different countries have different qualities. He also added that the Centre has to cooperate with agencies of European Commission, such as Health Agency in order to have a faster answer to all these challenges. Mr. Götz answered that there is no problem of communication with the Commission and that they hold 20 meetings per year with regard to methodology and standards and we can say that “now we speak a common language, the best you can find in the world”

Other issues were raised by different member of the Committee, such as the drug legalization and also the need for wide campaigns against drug consumption. Mr. Götz replied that legalization is not being discussed in any of the Member States now but there are some debates at the level of civil society. With regard to wide campaigns, he was very skeptical because there is no evidence that these campaigns actually work. Instead of that, he proposed targeted campaigns promoted in certain areas and within certain groups which are known to be at higher risk with regard to drug consumption.

In the end there was general agreement on the fact that the European Monitoring Centre for Drugs and Drug Addiction carries out a very important task and this should not be underestimated because what is at stake here, is the health of European citizens. For this reason the problem of funding is considered a main issue but there are some positive signs for 2015, also thanks to the work of LIBE Committee.

(Ana Daniela Sanda)

To know more:

European Drug Report 2014: Trends and developments published in May2014 by EMCDDA



Classé dans:COOPERATION INTERNATIONALE, COOPERATION JUDICIAIRE POLICIERE, Lutte contre la drogue, Lutte contre le crime organisé

Making the same mistake all over again: Juncker’s reshuffling of public health portfolios

Posted by on 25/09/14
By Anniek de Ruijter With the reshuffling of the Commission portfolios by president-elect Juncker, major units for EU public health protection move from DG SANCO to DG Enterprise and Industry. The changes to the portfolios come without further explanation and after the deadline for the Parliament to ask written questions has passed. One wonders: what did we learn from the BSE crisis?

More bad news: Mr Juncker replies to concerns on medicines

Posted by on 25/09/14

Mr Juncker has replied by letter to the concerns of the health sector on the transfer of medicines from DG Sanco to DG Enterprise/Internal Market. The letter says that one of the main priorities of the new commission is to create “A Deeper and Fairer Internal Market with a Strengthened Industrial Base” and to that end to establish a new DG for legislation for internal market of products and service (apart from financial services) and including “medicinal products”.

The transfer is therefore part of a wider process to strengthen the European pharmaceutical industry. DG Enterprise will be responsible for strengthening the European pharmaceutical industry AND for medicines, medicines regulation, medicines safety, and the European Medicines Agency.

This is exactly what the health sector opposes.

There is not some large transfer of responsibility for products and services to the new DG Enterprise/Internal Market. Medicines (or “medicinal products,” as the letter describes them) are the ONLY goods for which responsibility is transferred to DG Enterprise.

Food law is a key element of internal market laws but is not transferred to the new super Enterprise DG although that DG is responsible for strengthening the European food industry. Why were medicines singled out for transfer?

(There was a time, as it happens, when DG Enterprise was responsible for much food law but the Prodi Commission transferred that task to a new DG Sanco, so as to separate responsibility for food law from responsibility for promoting the food industry. The second Barosso Commission did the same for medicines.)

General product safety is the responsibility of the new Justice/Consumers DG. This is also an important element in internal market legislation but is not transferred to DG Enterprise. Again, why only medicines?

The letter does say that all proposals for decisions on medicines will be prepared “jointly” (my emphasis) by DG Sanco and DG Enterprise. This may be significant in bureaucratic terms but less so in practical terms. At best, DG Sanco will remain the junior partner , if indeed it can be called a partner at all. With medicines assigned to DG Enterprise in the Commission internal organigramme, DG Sanco will not have the resources to build up the knowledge base, expertise, experience, research data, and ongoing daily interactions with the world of medicines to match those of DG Enterprise.

Remember Glenis Willmott’s experience as rapporteur for the regulation revising the Clinical Trials Directives;
“When I was negotiating the transparency laws for clinical trial results, it was DG Enterprise that wanted to water the rules down”. Now it is DG Enterprise which will responsible for implementing that regulation.

(On a wider level, Commission approval is required for all aspects of the transparency policy of the European Medicines and it is the Commission and not the agency that has the final decision on the authorisation of medicines.)

I can think of one excuse for this letter. When there is not a good reason for a decision, or when you do not want to admit the real reason, the only option is to put forward bad reasons.

Given that medicines are singled out for transfer to DG Enterprise, given that this is exactly and precisely what the industry demanded, given that the decision overturns a reform of only five years duration, and given that DG Enterprise is also responsible for strengthening the European pharmaceutical industry I would say something I don’t think I have ever said before. Unless this decision is reversed, patients and consumers cannot have confidence in the regulation of medicines at EU level. END