Friday 25 April 2014

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Health & Consumers

 

EU health research: the vision of the European virtual institutes of health

Posted by on 23/04/14

In 2001, concerns about the competitiveness of Europe’s pharmaceutical industry led the European Commission to form a small, high-level group to investigate. The group, known as G10, chaired by two EU Commissioners and composed of major industry and governmental health stakeholders published its final report in May 2002. A few months ago, the European Federation of Pharmaceutical Industries and Associations (EFPIA) asked me to assess the progress

In particular, I looked at European initiatives aimed at creating a more cohesive biomedical research strategy across the continent. One of the G10’s main recommendations in this regard was the formation of a network of European virtual Institutes of Health, analogous to the US National Institutes of Health, linking centers of fundamental and clinical research to better integrate research across national borders. The G10 group could not itself form policy, but the European Institutions have adopted constructive legislation paving the way for the creation of the institutes of health.

I spoke to leading figures in EU health research projects and found that a number of significant initiatives in European health and medical research have been set up in the past decade. These include the European and Developing Countries Clinical Trials Partnership (EDCTP), the Innovative Medicines Initiative (IMI), and the Joint Programming Initiatives on Alzheimer’s and neurodegenerative diseases (JPND) and antimicrobial resistance (JPIAMR).

According to Ruxandra Draghia-Akli, Director at the European Commission (DG RTD), Europe is moving slowly to the goal of Virtual Institutes of Health and the European Commission has undertook a large amount of work into in this sense with high level meetings with stakeholders; bringing on the table the question of the appropriateness of developing a virtual structure that could be seen as like the National Institutes of Health (NIH) in the US.

Philippe Amouyel, chair of the management board of the JPND believes that European health research needs to achieve the level of integration developed in the JPI on neurodegenerative diseases. We need to avoid unnecessary duplication and waist of money in the different EU Member States.  Moreover, you have only the results of the research of your own country without any competitive and comparative interaction with the rest of Europe. A higher level of European cooperation, would raise the level of research excellence, and virtual institutes may be a step in the right direction, he says.

The suggested virtual institutes, however, have not been realized. And in general, duplication of effort, fragmentation and complexity are still major health-research issues for Europe in 2014. Over 90 per cent of public research and innovation funding in Europe is at a national level, and national health research systems still work along separate tracks. In comparison with other structural policy areas, such as competition, trade or industry, research remains less integrated and coordinated.

This lack of coordination stems from competing national priorities and a lack of political will. Michel Goldman, the executive director of IMI points out that there is no consensus among the different EU Member States to integrate more the national health research policies, although interesting efforts were made through the Joint Programming Initiatives. Member States remain keen to keep control on most of the health research, he adds.

Despite its skilled people and excellent research, bio-medicine in the EU is seen as less efficient compared with other major players such as the United States, Japan and South Korea. The existence of an EU equivalent of the US NIH would help to ensure adequate funding for European research into the development of new pharmaceutical products. It would also reduce duplication and fragmentation, and lead to a sustainable EU health research with major benefits for patients and public health.

A new development was last November’s announcement that Horizon2020 – the biggest EU Research and Innovation programme ever with nearly €80 billion of funding available over 7 years (2014 to 2020) – will include a Scientific Panel for Health. This researcher-led stakeholder platform will elaborate scientific input and provide a coherent scientific focused analysis of research and innovation bottlenecks and opportunities, related to the societal challenges of health, demographic change and well-being prioritized by Horizon 2020.

The panel results partly from advocacy by the BioMed Alliance, a non-profit association representing research-oriented medical societies. Julio Celis, the alliance’s vice-president, believes that the scientific community and the pharmaceutical sector are by and large ready for increased integration but that Member States are less willing. Researchers, clinicians, industry and SMEs, patients and regulatory bodies, really need to work together, in order to find a solution for sustainable research and deal with regulatory issues.There is need to incentive Member States to enter into collaboration and we must promote academia-industry collaboration, he says.

Horizon 2020 could offer a chance to do better. Current initiatives could be more integrated, building on the vision of the JPIs and the legal backbone of EDCTP. This would augment the existing efforts of the EU and the BioMed Alliance existing efforts, creating new public-public partnerships and combining EU, national, and in some cases industrial, funding.

This stronger integration of research infrastructures would in turn encourage an EU-wide restructuring of research capacities, based on scientific capacities and major health and societal challenges. It is essential to find a health challenge that all Member States consider as a high priority, around which the first European Virtual Institute of Health could be created. Once the first institute is in place, the rest will follow.

UK Government agency lacks resources to do its basic job

Posted by on 17/04/14
By Chris Whitehouse Staffing crises and soaring workloads at a UK Government Agency have forced it to throw up its hands in bureaucratic despair, a bizarre email acknowledgment suggests. Two main causes come straight to my mind...

My advice to the crop protection industry

Posted by on 10/04/14
The Risk-Monger recently spoke at a crop protection industry conference on how to prepare data requirements for implementing the new pesticides legislation. I am not sure they liked my main point: that the data they will generate does not matter ... at all. Still, they were polite.

Why eCommerce is under attack

Posted by on 10/04/14

Why eCommerce is under attack

May I start with a question? What do you think is one of the most innovative businesses in mankind? Commerce. To sell and buy is a business started from peer-to-peer business to mobile business today. Especially in the last two hundred years commerce developed the way to shop from flying merchants to marketplaces to shops to supermarkets to shopping malls to eCommerce and to Mobile-Commerce.  Millions of people like to shop online and use several innovative ways of commerce. The consumer decides how they want to shop, not governments and not enterprises.

But, eCommerce like we know it is under attack.

 

A growing number of brands and manufacturers are restricting Internet trade, for example using contract terms to stop sellers from selling goods on Online-Shops and online marketplaces.

 

What happened? Speaking with Online Sellers for many years now one topic is coming up louder and louder year by year. Platform Bans. After Adidas made it public mid 2012 that they are restricting sellers from selling online and via online marketplaces, this topic seems to be the biggest issue for Online-Trade. To be clear on that, platform bans mean that brand owners prohibit to sell on platforms and marketplaces like Allegro, Amazon, eBay, Priceminister, Rakuten and so on.

 

In my point of view manufactures and brands act against SMEs, cross-border trade, online and consumers. And this is not a gut feeling – EU Parliament is saying it as well.

 

At the study „Discrimination of Consumers in the Digital Single Market“ you can find the statement „From the consumer’s perspective, the distorted access to goods or services means discrimination within the internal market.”

 

But how does this discrimination works? Platform bans and other online restrictions mean that there is less Intrabrand and Interbrand competition. (Inter-brand competition is the competition between manufactures who are selling different brands of the same or equivalent goods. Intra-brand competition is competition among retailers of the same brand.) From this it follows less selection because brands only want new models on sell, less convenience because not each seller is able to run an app, less channels mean consumers cannot buy where they are used to buy, less availability because of less sellers, less information because of missing reviews and test reports. And all ends in higher prices.

 

We asked thousands of European SME Merchants if this is true. First thing we did was running a petition to see how important this topic is. Unexpected more than 14,000 small and medium businesses signed this petition, cross Europe and cross verticals.

The list of all SMEs who signed the petition was handed over to the Vice-President Olli Rehn in December last year.

 

To understand the status quo of online restrictions we ran a survey. Now we have input from more than 2,000 Online Sellers, all over Europe, all verticals and most are SMEs.

Close to 60% of business sellers are affected by platform bans, 15.3% more sellers than last year. The highest increase over last 4 years!

And more than 5% of European Business Sellers fear insolvency because of online restrictions by brands.

 

Next thing we asked for was the impact. And these numbers are remarkable, too.

More than 60% of the Business Online Sellers said that the amount of Online-Sellers will decline, Manufactures will obtain monopoly, diversity of supply will decrease and prices for consumer will increase.

 

To be clear, these points of impact describes the impact consumer will see. That means the consumer gets only goods brands want them to find like newest season models but cannot find the goods they are looking for and when they find it they have to pay much more because there is no free and no fair market anymore.

 

Last but not least more than 50% of the sellers said that innovation in Online-Trade will be reduced. And as you know innovation is the base for growth and employment.

These numbers show how important this issue of platform ban is for sellers. And this is the reason why so many sellers signed the petition.

 

What does it mean? Our claim isn’t complicated:

  • All parties should sit at a table and discuss the way how to run a successful eCommerce business
  • Policymakers and authorities must deal with restrictions and discriminations
  • We need more clearance on the legal side
  • And we need guidelines how to understand the legal rules

 

Let´s Stop Platform Ban and discrimination in Online-Trade. See you on http://www.choice-in-ecommerce.org

Oliver Prothmann

President of Bundesverband Onlinehandel e.V. (BVOH; German Federal Association of Online-Trade)

Founder of Choice in eCommerce – Initiative for Choice and Innovation in Online-Trade

 

 

Error in legislation kept in place for four years as no alternative could be found!

Posted by on 09/04/14

It seems common sense that, if an error is found in legislation, then this law should be immediately amended; at the very least, the erroneous provision should not be allowed to influence the course of a related court proceeding. This is not, however, how some EU Member States seem to view such a scenario.

Three years ago a company called me up with quite a technical problem relating to import duties on whey protein products. In essence, this company was being faced with a very large demand of back duty from the UK tax authority, Her Majesty’s Revenue and Customs, based on the results of a test for milk fat provided in EU legislation. It rapidly became apparent that this test was faulty and gave wrong results when applied to whey protein products – this placed the products in a category for which higher duty was demanded.

This should have been an easy case to solve: since the test had been proven to throw up results that were wrong, the UK authority should have withdrawn its demand, whilst asking the European Commission to amend its legislation.

Instead, however, the case escalated to the tax tribunal and ultimately required a three year long lobbying campaign just to ensure that a responsible company was not penalised on the basis of an erroneous provision. Who is to blame is hard to say, as all authorities involved had their reasons – some reasonable, some less so.

The UK tax authority was bound to apply EU legislation (even if erroneous); the European Commission could only amend the rules on the basis of an independent scientific analysis (itself quite time consuming), and any resulting amending legislation could only be adopted if approved – or a at least not opposed – by the EU Member States (who, for their own reasons, didn’t support the solutions presented by the Commission).

The issue was a drain on the time and effort of virtually everyone involved. Without the assistance of Members of the European Parliament, national Parliamentarians, the US authorities and a strong EU wide public affairs campaign continually pressing for action form all involved, the issue could still have dragged on into the next European Parliament, requiring even more time and effort to brief new MEPs.

We are now hopefully only a couple of weeks away from a provisional solution that will ensure that a responsible business is not penalised until an alternative scientific test for milk fat is proposed and adopted at the EU level. The Commission now needs to formally adopt its proposed amendment that was debated – at length – by the then 28 EU Member States, who all had different views as to how the issue is to be tackled.

This issue has not shown the European Union at its most dynamic, even despite the Commission being very helpful and proactive. What the three-year-long saga has shown, however, is the value of a consistent and informed lobbying campaign. Only a campaign that harnesses specialist knowledge of the European decision-making process and the bodies involved can give one company a chance, in the face of institutional sluggishness, of fairly resolving a complicated tax case such to nearly everybody’s satisfaction.

Chris Whitehouse is Chairman of leading public affairs consultancy ww.whitehouseconsulting.co.uk whose Food Regulation Team advise many organisations and businesses in the specialist food product sector. He is also Director of Strategy of consumer organisation Consumers for Health Choice www.consumersforhealthchoice.com and of the European Specialist Sports Nutrition Alliance www.essna.com.

 

Die Rentenpolitik in Europa

Posted by on 04/04/14

Klar, es ist ein Entwurf. Und das er aus der Beratung im Parlament nicht so herauskommt wie die Arbeitsministerin ihn dort heute hineingegeben hat, ist gewiss. Gerade in der Rentenpolitik hat sich das Parlament selten als Abnicker von Regierungsentwürfen erwiesen. Hinzu kommt, dass Andrea Nahles schon selbst Nachbesserungsbedarf angemeldet hat; sie hofft am Ende auf einen Weg, den Missbrauch der Frühverrentungen verfassungssicher zu gestalten.

Das mag juristisch gelingen – ordnungspolitisch sauber wird es aber wohl nicht werden. Denn der Rentenpolitik fehlt schon seit Jahren ein Maßstab. Die aktuellen Entscheidungen um die abschlagsfreie Rente mit 63 und die Finanzierung der Mütterrente verstärken den Eindruck, Rentenpolitik werde vor allem nach Kassenlage gemacht: Geht es gut, wie jetzt, gibt es spendable Ideen; geht es schlecht, wird die Rentenformel geändert, zum Beispiel von der Brutto auf die niedrigere Nettoanpassung der Renten.

Im aktuellen Fall könnten die Beitragsjahre der Maßstab sein. Dann gäbe es keinen Krach und viel Rechtsicherheit. Wer eine Mindestzeit Beiträge eingezahlt hat, hat einen äquivalenten Anspruch auf Rente. So wie jetzt diskutiert wird, denke ich an meinen Volksschulkumpel Manfred: Der verließ mit 15 die Schule und lernte Automechaniker. Wenn er das immer noch macht, hat er jetzt, mit 62 Jahren 47 Jahre gearbeitet und Beiträge gezahlt. Er erhält aber keine abschlagsfreie Rente, weil er erst 62 ist. Anders bei meinem Kommilitonen Volker: Er hat erst mit 27 begonnen versicherungspflichtig zu arbeiten, wird aber, wenn er die Rente mit 67 abschlagsfrei bekommt, nur 40 Jahre Beiträge gezahlt haben. Mit welchem Argument kann man Manfred nach 47 Jahren die abschlagsfreie Rente verwehren, sie aber Volker nach 40 Beitragsjahren zugestehen?

Die Antwort ist: Die staatliche Versicherung ist keine Versicherung. Die Regierungen haben die ursprünglich stärker an Versicherungsgrundsätzen ausgerichtete Sozialversicherungen immer mehr zum Versorgungssystem umgebaut. Erworbene Rechte werden darin nicht wie Eigentum behandelt. Passt es einer politischen Mehrheit, Müttern eine höhere Rente zuzubilligen, zahlt sie dafür nicht etwa selbst. Nein, sie greift erst einmal in die Beitragskasse, die Versicherte und ihre Arbeitgeber gefüllt haben. Gesetze, die bei gut gefüllter Kasse niedrigere Beiträge vorschreiben, werden kassiert. Was gut gemeint ist, muss nicht gut ausgehen: Eine Rentenversicherung, der die Maßstäbe von Leistung und Gegenleistung abhanden kommen, kann auf Dauer nicht sicher und vertrauenswürdig sein.

Studie “European Hospital Rating Report

Posted by on 04/04/14

Fast die Hälfte (46 Prozent) der europäischen Krankenhäuser ist in einer wirtschaftlichen Schieflage und nahezu jedes fünfte hat ein stark erhöhtes Insolvenzrisiko. Zu diesem Ergebnis kommt die Studie “European Hospital Rating Report” des Managementberatungs-, Technologie- und Outsourcing-Dienstleisters Accenture in Zusammenarbeit mit dem Rheinisch-Westfälischen Instituts für Wirtschaftsforschung (RWI). Die Ergebnisse zeigen eine starke paneuropäische Streuung: Während in Portugal fast 60 Prozent der Krankenhäuser finanziell angeschlagen sind, diagnostiziert der Report in Deutschland und der Schweiz bis zu 80 Prozent gesunde Krankenhäuser.

Für den europaweiten Vergleich hat Accenture mit Hilfe des RWI über 1.500 Jahresabschlüsse von Krankenhäusern aus neun Ländern untersucht, die rund 30 Prozent des Krankenhausmarkts der untersuchten Länder abdecken. Im Fokus stand die Finanzkraft der Krankenhäuser aus Belgien, Deutschland, Frankreich, Italien, Norwegen, Österreich, Portugal, Spanien und der Schweiz. Portugal und Frankreich stehen mit ihrem Krankenhauswesen insgesamt im insolvenzgefährdeten Bereich. Nur in Deutschland, der Schweiz und Belgien befindet sich die große Mehrheit der Krankenhäuser im wirtschaftlich gesunden Spektrum. Da ein Klassifikationsmodell verwendet wurde, das einen internationalen Vergleich erlaubt, weichen die Ergebnisse für Deutschland von denen des Krankenhaus Rating Report 2013 ab.

“Auch wenn die deutschen Krankenhäuser im Vergleich zu anderen europäischen Ländern zu den Klassenbesten gehören, ist das kein Grund zur Entwarnung. Denn die Kluft zwischen finanziell erfolgreichen und finanziell schlecht aufgestellten Kliniken wächst rasant”, erklärt Dr. med. Sebastian Krolop, Leiter Accenture Strategy im Geschäftsbereich Healthcare bei Accenture Deutschland und Autor der Studie. So hat sich die Profitabilität der wirtschaftlich erfolgreichsten Kliniken zwischen 2008 und 2011 kontinuierlich verbessert und die der unwirtschaftlichsten kontinuierlich verschlechtert. Die Studie zeigt auch, dass 33 Prozent der europäischen Klinken 2011 rote Zahlen geschrieben haben.

“Die Situation im Krankenhauswesen hat sich für Deutschland, aber insbesondere für unsere südlichen Nachbarn, seither nicht verbessert”, sagt Sebastian Krolop. Unabhängig von der Bonität können Krankenhäuser auch mit einer höheren Profitabilität über den operativen Cash Flow Investitionen tätigen. Die Profitabilität der deutschen Krankenhäuser ist mit 8,5 Prozent überdurchschnittlich und lediglich 19 Prozent der Krankenhäuser befinden sich im finanziellen Risikobereich. Im europäischen Vergleich weisen italienische Krankenhäuser mit 12,1 Prozent die höchste Profitabilität auf, diese ist viermal so hoch wie diejenige der Schweiz.

“Die finanzielle Schräglage vieler Krankenhäuser in Europa ist häufig strukturbedingt. Diese Krankenhäuser müssen nun gezielt ihr Verbesserungspotential ermitteln, um wettbewerbsfähig zu werden. Spezialisierung, Verbundbildung und Qualität sind die wichtigsten Erfolgsfaktoren. Unsere Studie zeigt, dass die europäischen Gesundheitssysteme dringend die Fragen bezüglich adäquater Finanzierung, Krankenhausstruktur und Qualität beantworten müssen. Ansonsten besteht die Gefahr, dass sich diese beunruhigende Situation zu einer Krise entwickelt”, erklärt Sebastian Krolop.

Anders als im deutschen Krankenhaus Rating Report 2013 (Krankenhausversorgung zwischen Euro-Krise und Schuldenbremse. medhochzwei. Heidelberg) werden die Mittel aus dem Krankenhausfinanzierungsgesetz (KHG Mittel, auch Sonderposten) als Eigenkapital gewertet. Hierdurch ist die durchschnittliche Ausfallwahrscheinlichkeit (Probability of Default. PD) für Deutschland in dem European Hospital Rating Report mit 0,6 Prozent niedriger als in dem deutschen Krankenhaus Rating Report mit 1,2 Prozent. Somit ergibt sich eine Abweichung in der Methodologie, welche auf die Datenstruktur der ORBIS Datenbank zurückzuführen ist. Aus Gründen der Vergleichbarkeit wurde für alle Länder eine identische Vorgehensweise bei der Ermittlung der Ausfallwahrscheinlichkeit angewendet. Wenn man für die Stichprobe der Krankenhäuser des deutschen Krankenhaus Rating Report diese Methodologie adaptiert, erhält man die gleiche durchschnittliche Ausfallwahrscheinlichkeit für deutsche Krankenhäuser (0,6 Prozent). Die Addition der Sonderposten zum Eigenkapital wirkt sich zudem auf die EBITDA Marge aus. Die durchschnittliche EBITDA Marge für deutsche Krankenhäuser ist durch den Effekt im European Hospital Rating Report mit 8,5 Prozent höher als in dem deutschen Krankenhaus Rating Report, welcher eine durchschnittliche EBITDA Marge von 5,2 Prozent ausweist.

Über die Studie:

Mit dem Ziel, die finanzielle Leistungsfähigkeit des europäischen Krankenhausmarkts zu beurteilen, hat Accenture in Zusammenarbeit mit dem RWI mehr als 1.500 Jahresabschlüsse des Jahres 2011 von Krankenhäusern in neun europäischen Ländern untersucht: Belgien, Deutschland, Frankreich, Italien, Norwegen, Österreich, Portugal, Spanien und die Schweiz. Ein Accenture-Klassifikationsmodell, angelehnt an die modeFinance MORE Rating-Klassen des Bureau van Dijk, bietet eine Einschätzung der Kreditwürdigkeit dieser Krankenhäuser und beurteilt deren Ausfallwahrscheinlichkeit innerhalb eines Jahres auf der Grundlage einer Bilanz und Gewinn- und Verlustanalyse. Um einen internationalen Vergleich zu ermöglichen, weicht die hier eingesetzte Methodik von der im Krankenhaus Rating Report verwendeten ab, unter anderem wurden Sonderposten als Eigenkapital gewertet. Die Höhe der Ausfallwahrscheinlichkeit ist daher eine andere als im deutschen Krankenhaus Rating Report. Die folgenden zwei Faktoren standen bei der Analyse im Zentrum: die Ausfallwahrscheinlichkeit (die Wahrscheinlichkeit, dass eine Organisation insolvent wird) und die EBITDA Marge (Gewinn vor Zinsen, Steuern und Abschreibungen), welche die operative Leistungsfähigkeit vor Investitionsaufwand angibt.

Two days – two pieces of good news

Posted by on 03/04/14

Yesterday (2nd April) the Plenary Session of the European Parliament approved the final text of the Regulation revising the Clinical Trials Directive. The announcement from the Parliament can be seen here. Since this text was negotiated with the Commission and Council (the national governments) it will soon be agreed formally in Council.

Today (3rd April) I hear from BEUC that Abbvie are withdrawing their legal challenge to the new transparency policy of the European Medicines Agency. This may not be a coincidence since I think it would be harder for them to win their case with the passing of the new Regulation. At any rate, their decision is the right one for all kinds of reasons.

At time of writing I have no news of the position of Intermune who have launched a similar challenge against the EMA.

Attached is the text of the new Regulation as adopted by the Parliament. Strictly speaking it is a provisional text at this stage but I do not expect any significant changes.

Someone said recently that “Victory has a thousand fathers, but defeat is an orphan.” In this case I think the European Parliament has a special claim to paternity (or maternity in the case of Glenis Willmott MEP) but credit also to the European Commission (DG SANCO) and the 28 member governments in the Council.

What marathons teach us

Posted by on 03/04/14
As marathon season gets started, the Risk-Monger ponders how those with passion can go the distance, and how business leaders that don't seem to have the stamina continue to lose.

When design meets medtech: Three ideas in preventing and managing pressure ulcers

Posted by on 02/04/14
The work we do at the Helen Hamlyn Centre for Design at the Royal College of Art in London focuses on developing projects with a strong emphasis on identifying and understanding everyday situations that people have difficulty with. Our approach is inclusive: we work with many ‘users’ of a product, service or system in order [...]

Big risk

Posted by on 27/03/14

What’s the biggest risk factor on earth – causing deaths and diseases for millions? Travel by plain or car? Alcohol and Cigarettes? Bad habits in food consumption? Wars? Sharks? No! It’s not about what’s coming initially in people’s minds. It’s the bad air, too many people are breathing. In 2012, seven million people died of air pollution exposure, according to new estimates by World Health Organization (WHO). One in eight global deaths is caused by the world’s largest health risk. CO2-emmission trading and prevention schemes like we are having in Europe are far above those problems. But the approach should be a role model for the world as Europe started itself not from a very high level. And it’s worth to spend time and financial efforts on it. It’s about nothing less than the world’s biggest risk.

Watch out for more: http://www.euractiv.com/sections/health-…

MedTech will not be wiped out by Apples or Googles – but here’s something to think about

Posted by on 27/03/14
“Nihil novi sub sole” said the Vulgate. That could not be farther from reality when it comes to the MedTech Europe blog. And I am privileged to be the first author to “lay pen to paper” and contribute to MedTech Views, an initiative by MedTech Europe to establish a true platform for dialogue about medical [...]

Food supplements under threat

Posted by on 21/03/14

Consumers are gearing up for a major battle with global food supplement companies to prevent consumer choice being sacrificed on the altar of European harmonisation.

In the EU, food supplements are regulated as foods and the vitamins and minerals they contain are regulated through harmonised rules. This rather dry statement of fact doesn’t quite catch some of the fundamental issues which characterise the sector, such as the seemingly never-ending row around the setting of maximum permitted levels of vitamins and minerals (MPLs) in food supplements per daily portion of consumption.

More than ten years have passed since the Food Supplement Directive (2002/46/EC) established that MPLs should be set at EU level. The level of consumer opposition to such a measure has been vociferous ever since, and rightly so. Across Europe, people have very different dietary patterns and nutritional requirements, and even within the same country there are wide differences between population groups. In the UK, to take one prominent example, people are used to consuming supplements with higher amounts of vitamin and minerals than those sold in other EU countries, a long-standing tradition which has seen millions of consumers safely taking higher potency supplements for decades.

As a result of this consumer opposition, progress on the implementation of MPLs has been almost non-existent, with the Commission still working on a solution today. Much of this very successful opposition has been channelled through the campaigning organisation Consumers for Health Choice (CHC), of which I have been Director of Strategy for nearly twenty years. But, it has not been an easy ride as we have had to battle against powerful commercial interests which would like to sacrifice consumer choice on the altar of harmonisation at all costs.

Over the years we have had to compete with well-funded, well-organised lobbying groups pushing for the exact opposite of what CHC and the vast majority of consumers want. Some big businesses would indeed be very happy to achieve a ban on higher- and medium-potency supplements, eliminating their small specialist rivals from the market and forcing consumers to buy their products. With harmonised levels across the EU, companies would be able to sell one product in 28 countries, so these giant corporations would be raking in the profits as well as slashing their costs.

In the past few months, yet another of these lobbying groups has been set up to campaign for the European Commission, MEPs and governments of Member States to bring forward proposals for MPLs – and fast. This group is Food Supplements Europe (FSE); they represent big, in some cases American multinational vitamin and mineral companies who want MPLs harmonised at very low levels, ignoring the dietary needs of different population groups.

I share the outrage expressed by some of my fellow CHC campaigners in recent press articles; this is a relentless attack on consumer choice, hoping in this case to exploit the upcoming political uncertainty over the next few months, with European Parliament elections in May and a new set of European Commissioners appointed in the autumn. With a new intake of inexperienced MEPs in Brussels and a new Health Commissioner, they will hope to press their arguments in favour of forced harmonisation and the setting of maximum permitted levels.

This must not happen. CHC will be in the arena, fighting hard to preserve consumer access to these safe, higher-potency supplements. Though FSE may have resources, CHC know that we have the support of millions of consumers and small businesses throughout the UK and Europe. CHC will be there, as we have been for twenty years now, to make sure that consumer voice is always heard.

Chris Whitehouse is Chairman of leading political consultancy www.whitehouseconsulting.co.uk whose Food Regulation Team advise many organisations and businesses in the specialist food product sector. He is also Director of Strategy of consumer organisation www.consumersforhealthchoice.com.

What secrets can trade have… and keep? Notes.

Posted by on 19/03/14

These are my notes for a speech I made today in the European Parliament on the proposal for a directive on trade secrets.
1 I will not say anything here about the proposal itself in terms of its principal objective but will talk about some possible indirect effects.
- in relation to journalists, whistleblowers and activists such as consumer advocates who may see, and wish to disclose, information or documents that are trade secrets as defined in the proposal.
- in relation to access to information under 1049/2001 and related measures.

2 On clinical trial results there have been two pieces of good news recently.
-The EMA announced a new policy of greater transparency, including publication of “Clinical Study Reports” received in applications for medicines approvals. In taking their initiative the EMA followed a careful analysis by the Ombudsman as to what was and was not commercially confidential information in this context. Two companies, Abbvie and Intermune, have taken legal action to block publication of the CSRs.
-In the revision of the Clinical Trials Directives the Parliament inserted an amendment to require that CSRs be placed on a central database/portal within one month of a decision on an application for a medicines approval. The Parliament also inserted a recital to the effect that CSRs should not generally be considered as commercially confidential – thereby opening the way for access to the CSRs under 1049/2001.
CSRs have scientific value and in many cases would fit the definition of trade secret in the current proposal.
Crucial to both these initiatives is the definition of commercially confidential information. If you can widen the definition from that set out by the Ombudsman you can limit access to Clinical Study Reports.
3 The industry, on both sides of the Atlantic, were strongly opposed to the requirement to publish CSRs. They argued that the TTIP should “establish harmonized list of clinical trial result data fields & agree on which may be disclosed to public (uniform protection of confidential commercial info & trade secrets)” . More generally they will seek to widen the definition of what is commercially confidential information, with the aim of restricting disclosure under 1049/2001.

4 The proposal on trade secrets explicitly states in recital 9 that disclosure under 1049/2001 or other laws on access to information “should not be considered unlawful..”. However, this still leaves open the possibility that the definition of trade secrets in the current proposal may have the effect of changing what is seen as commercially confidential information under 1049/2001 and similar measures.
5 The remedies in the proposal can clearly be used against journalists, whistleblowers and activists/advocates in certain cases — to demand the return or destruction of documents and for damages in certain cases.
However Article 4.2 requires member states to block remedies under the proposal when disclosure is
-for making legitimate use of the right of freedom of expression and information
-for revealing an applicant’s misconduct, wrongdoing, or illegal activity
-for protecting a “legitimate interest”..
Is this enough?
6 Possible Problems
In relation to journalists will the proposal reduce national protections in some (of the more progressive) member states?
Will the burden of proof be on the respondent/journalist to prove “legitimate use of the right of freedom of expression”?
Will this affect procedural law or protections in (some) member states?
What is the scope and implication of the reference to a legitimate interest?
Does it include the public interest in knowing that some medicines (or other product) do not work in certain circumstances?
Is the advancement of science, or human health, a legitimate interest – or should it be?
7 Possible amendments
Give more positive protection (an exemption is hardly possible) to journalists, whistleblowers, and activists without any commercial interest in disclosure.
No damages/compensation for disclosure in the absence of a commercial motive.
Exclude disclosure to a competent public authority.
Allow a wider public interest defence.END

I Pollute

Posted by on 18/03/14
Imagine a religion that looks at the problems in the world and concludes that it is because others sin. “If only they could be more like me!” A faith without humility and mercy is hypocritical – a congregation of zealots. As environmentalists build their beliefs into their new temple, the eco-theologians need to remind their followers of the virtue of humility – that they are not without sin.

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