Friday 22 August 2014

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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.

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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 [...]

Maladministration in the European Medicines Agency?

Posted by on 05/06/14

The latest version of the EMA transparency policy gives significant weight to copyright law and intellectual property rights (IPR). In responding to the Ombudsman’s concerns about changes in its transparency policy, the agency cited a “clear message” from the Commission of the requirement to respect intellectual property rights That requirement, whatever it is, is also one of the subjects in “ongoing discussions” with the Commission on access to documents in the agency.

A few days ago, the American Chamber of Commerce published a report strongly critical of the proposed new transparency policy of the EMA (and of the EU more generally). Much of its opposition relied on arguments in relation to IPR.

Clearly, the EMA must carefully assess what precise obligations it may, or may not, have under copyright and IPR law. The way it is going about it does not inspire trust or confidence.

We don’t know precisely what conclusions the agency has come to about copyright law, we don’t know what the Commission said to the agency about copyright and IPR law and we don’t know what is being said about copyright and IPR in the ongoing discussions between the agency and the Commission about access to documents. (We don’t know either if the Management Board of the agency will have access to all the background documents when it meets to discuss the new transparency policy on 12th June.)

The new Head of Legal at the agency is Mr. Stefano Marino, who came from a long career at senior level in the industry, including seven years as Chairman of the Trademark Committee and thirteen years a member of the Intellectual Property Protection Committee of EFPIA, the pharmaceutical industry association. I’ve said before and I repeat here that I do not imply any personal impropriety or the slightest lack of integrity on Mr. Marino’s part, but there is an issue of public policy here. Has the EMA’s chief legal adviser played an important role in shaping the agency’s response to industry arguments about copyright, TRIPS and IPR – arguments that presumably he helped to shape over many years as a senior IPR expert in the industry association?

Is the EMA’s handling of this issue to date likely to increase public confidence in the agency? Emphatically not, in my opinion.

In my view, the agency should seek (and publish) independent external advice on the implications for transparency of copyright law and IPR law generally. This is no reflection on Mr. Marino – in private practice, lawyers who change employers are usually precluded for a time from dealing with issues in which they were previously involved for another interest. Something similar should be done here.

Secondly the agency should publish the advice it receives from any source, including the “clear message” from the Commission. On such a crucial and important issue, there must be full public scrutiny.

For the reasons outlined above, the Management Committee of the agency should not approve the recent changes in policy next Thursday. (A further reason is that the Ombudsman is still examining the recent practices of the agency here.)

The legal opinions and interpretations of complex law that form the basis of the agency’s new policy on transparency are not disclosed or subject to public scrutiny. This is bizarre and, to put it bluntly, mal-administration.

The current discussions behind closed doors will have wider effects. The same considerations of copyright and IPR will clearly feed into other, distinct, policy areas including access to documents, and the implementation of the new regulation on clinical trials. All the more reason for transparency. END

Health-2-Market e-learning – New chapters are now available

Posted by on 04/06/14

The Health-2-Market e-learning has been developed to boost the entrepreneurial skills of health and life sciences researchers. The e-learning offers interactive learning environment for interested participants in starting their own business. The e-learning can be used as a standalone course or as a supplementary training to the face-to-face events.

 

 

The Health-2-Market e-learning has been launched in September 2013 since then more than 500 participants registered for the e-learning service. Our service is not only a traditional e-learning. Chapters offer self assessment quizzes, additional documents, and from this autumn Real Time discussion sessions will be organized in the most popular topics. By using the Classmate function the participants can contact each other and discuss common issues, questions.

In addition to the presentations of the three courses: Entrepreneurship and Business Planning, (SKEMA Business School, France); Business Ventures & Marketing (IE University, Spain); Intellectual Property & Ethics (University of Gothenburg) several case studies have been uploaded recently. The case studies, presenting real life case examples will help the participants applying the knowledge gained from the e-learning presentations. The case studies are discussing a number of topics, such as establishing a marketing strategy, utilizing early stage research result through intellectual asset portfolio management, business planning, etc.

If you are interested in receiving a unique interactive training from the professionals of the Health-2-Market consortium, please visit our website http://elearning.health2market.eu/ and sign up for our e-learning services.

 

Honey won’t sweeten the opposition

Posted by on 03/06/14

A move by the Commission to amend the law on honey won’t buy off opposition from the anti-GMO lobby.

The European Commission has today published Directive (EU) 66/2014 amending Council Directive 2001/110/EC relating to honey. This new piece of legislation constitutes a review of the Honey Directive that was triggered by a ruling of the European Court of Justice from September 2011 (case C-442/09), which stated that legislation on genetically modified organisms (GMOs) applies to honey and that pollen in honey is an ingredient.

Classing pollen as an ingredient of honey would have seen a number of additional compulsory labelling requirements imposed on honey producers, including that of indicating the presence of  any genetically modified pollen. However, the new Directive clarifies that pollen is not an ingredient but a natural constituent of honey. While this does not mean exemption from GMO labelling rules for honey, only products which contain genetically modified pollen in a proportion which exceeds 0.9% of the total honey will have to be labelled as being “food (partially) produced from a GMO.”

As often with the sensitive subject of GMOs, the new piece of legislation has already attracted considerable controversy with anti-GMO campaigners denouncing it as a ‘significant weakening of the EU’s protection against GMO contamination’. On the other hand, the new Directive represents a positive development for the industry, which will see the burden of labelling and bureaucratic procedures reduced.

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.

Where next for tobacco control in Europe?

Posted by on 02/06/14
Guest blogpost by Catherine Castledine of Cancer Research UK. Like any milestone, World No Tobacco Day (WNTD) presents a chance to both take stock and look to the future. Where next for tobacco control? What are the challenges we face? How can we do more to prevent tobacco harm? As WNTD draws to a close for another [...]

Food sector: Legislative and regulatory developments after the elections

Posted by on 02/06/14

The European Union exists to regulate, and therefore it regulates, as Descartes would have said; and in no area is that more true than in that of food law argue food law experts Kasia Wilk & Chris Whitehouse.

The European Union is not particularly popular at the moment, and many would like to repatriate a good number of powers – if not leave the Union once and for all. Food law is one of those areas that has been quite extensively dominated by the EU legislators in the past decade. Clearly not all the rules adopted at the EU level have done a great job, but many would argue that the internal market has been overall quite positive for both EU consumers and food businesses alike. Food products are traded extensively across the continent, and harmonised rules, if proportionate and balanced, can help to ensure costs are minimised for businesses while providing better consumer protection.

Constant Regulation

The past ten years have seen some significant legislative developments: from the recent reforms of the common agricultural policy, new rules on nutrition and health claims, new food information/labelling requirements, new legislation covering foods for specific groups or recent proposals to reform novel foods legislation, official controls along the whole food chain, organic production/labelling; not to mention the establishment of union lists of additives or flavourings. The last few years have certainly not been quiet for food businesses, who have had to continuously adapt to new requirements. This is unlikely to change over the next legislature, despite the political turmoil currently taking place, as work will continue on many of the initiatives already on the table.

Nutrition & Health Claims

The Regulation on nutrition and health claims made on foods, adopted in 2006, is still being implemented and is a serious headache for all concerned. This includes the regulators who still have to implement some of its requirements, but who have decided to place many issues – such as botanical health claims or nutrient profiles – on hold due to unforeseen complications; the enforcement authorities who are struggling with uniform interpretation and enforcement of the rules; and in particular food business operators who are trying to survive through this regulatory storm. This Regulation or rather its implementation has been quite extensively criticised, threatening a number of sectors, with the notable example of ‘probiotics’ or ‘botanical supplements’. There have been calls to change the European Food Safety Authority’s (EFSA) health claims assessment process, compared by some to a ‘pharma-style’ model, and it remains to be seen how regulators and the industry will cope with the next steps of this legislation, quite significantly delayed already.

Information to Consumers

Industry will also have to deal this year with the new labelling requirements of the Regulation on food information to consumers which will apply from 13th December 2014. There is still some uncertainty regarding the interpretation of certain provisions, and guidance development is a long process. Some implementing/delegated act still needs to be adopted, and issues such as country of origin labelling for certain product such as meat or milk, on which reports have been foreseen, are likely to be brought forward in light of last year’s horsemeat scandal.

Infant, Medical & Slimming Foods

The next two years will also see the implementation of the Regulation on foods for specific groups covering foods for infants and young children, medical foods and slimming foods. This Regulation revises the whole framework currently covering dietetic foods and will also have an impact on other foods which were previously in a regulatory limbo, including sports foods, gluten-free / lactose-free foods or foods for diabetics. Whilst EU legislation is often criticised for being burdensome, this Regulation is clearly an attempt by EU regulators to reduce red tape. The European Safety Authority and the Commission are currently working on the detail of the delegated measures provided for by the Regulation; and businesses concerned should not miss this opportunity to engage.

Protecting the Food Chain

Work in the European Parliament and the Council will continue on the Commission’s proposed package of measures designed to strengthen the enforcement of health and safety standards for the whole agri-food chain. The package of reform cuts the current body of EU legislation covering the food chain down to five pieces of legislation – dealing with the areas of official controls; animal health; plant health; and plant reproductive material. This package, which has already been debated by the Parliament at first reading, is now awaiting Council’s first reading position.

Novel Foods & Cloned Animals

Novel food/ ingredients, as well as foods from cloned animals, will also give rise to an important debate. Whilst a previous Commission proposal to reform the framework has been blocked over the issue of cloning, the Commission has presented new drafts that will be discussed by the European Parliament and the Member States in the next two years.

Organics

Just before the elections, in March, the Commission also published a proposal reforming the regulatory framework covering organic products. Clarity and commitment to cut down on the sort of food fraud which can imperil the organic sector’s reputation is all welcome. But, some in the EU are uneasy that new rules may be far too burdensome and there are ominous rumblings from the two big EU powers, France and Germany, that they are particularly dissatisfied.

Sustainability & Public Health

The above legislative dossiers and foreseen initiatives are not the end of the list.  Food sustainability is also high on the political agenda with a target of reducing edible food waste by 50% by 2020. A communication from the European Commission on this issue is expected quite shortly, and many point their finger to dates of minimum durability/ ‘use by’ dates as a solution. Public health issues also add pressures on the Commission to address some pressing problems such as obesity, and debates around food taxes may therefore start again.

Transatlantic Trade Negotiations

Finally, whilst the EU continues work on strengthening consumer protection, often adding regulatory complexity, few are concerned by the Transatlantic Trade and Investment Partnership (TTIP) on which negotiations have started. The aim of this agreement is to remove trade barriers (tariffs, unnecessary regulations, restrictions on investment etc.) in a wide range of economic sectors so as to make it easier to buy and sell goods and services between the EU and the US.  How this will work out for the food sector – where regulatory approaches are often radically different – is questionable, and this certainly deserves great attention and engagement, in particular in light of the opaqueness of the negotiations being conducted.

Time to Engage

Businesses must wake up and engage. Changing and influencing the legislation is possible, and we at Whitehouse never fail to be surprised by the number of those who prefer to pay the massively bigger cost of complying with inappropriate requirements rather than engaging with the legislative process to mitigate the impact of burdensome legislation whilst that is still possible.

Authors: Kasia Wilk & Chris Whitehouse

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.

 

Transparency – Is the Commission Pulling the Strings in the EMA?

Posted by on 29/05/14

The European Medicines Agency has published its letter of reply to the Ombudsman’s concerns about changes in transparency – see my previous blog.

The letter makes the point that the new transparency policy is an initiative of the agency itself and is quite distinct from the access to documents regime under Directive 1049/2001, and also distinct from arrangements to be put in place under the new clinical trials regulation. I thought that was the case but remain concerned about the initiative itself.

In the letter the EMA offers assurances that data will be disclosed in a “user-friendly” manner to which the general public will have access, with freedom for academics to review, communicate etc. This is not the impression that I, or many other people, got from the latest targeted consultation.

However, the points in the letter that most worry me are the references to the Commission’s ‘clear message’ that the EMA must comply with “ national and international obligations that all European institutions have to comply with, including but not confined to TRIPs and copyright laws.” This is correct as a general principle, but what does it precisely mean in this case?

I know a little about these obligations in general terms but we need to know how exactly the Commission interprets them in relation to the disclosure of clinical trial results. Which if any of the more restrictive terms in the recent EMA consultation documents are there because of the Commission’s interpretation of these obligations? Can we see exactly how the Commission interprets these obligations? Did the Commission tell the (independent) agency what it could and could not do or did the agency make its own assessment of its obligations here? If it was indeed the agency which assessed these obligations, can we see that assessment?

Much more seriously, how will the Commission’s view of these obligations impact on the rules on access to documents under Directive 1049/2001, on which the EMA is having “ongoing discussions with the Commission”? The rules and procedures here seemed to be fairly well settled. Will they now be changed for the worse as a result of these ongoing discussions?

Even more seriously, how will all this affect the implementation (by the Commission) of the new clinical trials regulation, with its commitment on the part of the legislators to very much wider transparency? Does the Commission believe that the TRIPs agreements and copyright laws may frustrate the will of the legislators here, and if so how? We should be told.

The Commission position on TRIPs and copyright laws is having, and will have, a clear impact on EMA policy on transparency and access to documents, and on the future transparency of clinical trial results. If that position is not subject to full public scrutiny, I would have no confidence in the Commission and the EMA here.

The Commission must also come clean on how exactly TRIPs and copyright laws may affect or frustrate the promise of transparency implied in the new clinical trials regulation. Was the work of the Parliament in vain here? Did the Commission brief the Parliament on these issues during the trilogue? END

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