Personally Speaking

When I was asked that question I thought they were talking about the rose-cheeked girl on the Swiss Alps. I answered yes whilst trying to figure out in my head what Heidi has to do with health.

Plenty I found out. HEIDI is the acronym for Health in Europe - Information and Data Interface. It is an internet based tool, which offers patients, health professionals and anyone who is interested, the latest up-to-date data and information on health issues at European level. It allows experts to share and compare the latest sets of data in real time, across the whole of Europe. Health experts will be granted access to write in text and add comments, graphs and other information sources. It contains data on health status, determinants, diseases, health systems, trends, institutional and policy aspects - and much more.

And why is it important? The answer is simple. HEIDI brings data, comparable across Europe, to the fingertips of the people that matter. It serves to develop policies based on evidence, policies which improve the health of us all.

There is also a similarity with the fictional Heidi. In Johanna Spyri's book, she nursed her friend Clara back to health. Our own HEIDI can help us do the same, this time improving the health of all Europeans.

• https://webgate.ec.europa.eu/sanco/heidi/index.php/Main_Page

The Commission is preparing a proposal for the revision of the Clinical Trials Directive for later this year. Clinical trials are crucial to many people! They provide hope for patients and relatives; essential testing for researchers and industry to develop new medicines and treatments; are key for the creation of growth and jobs in the public health sector and; play a major role in R&D accounting for investments of over €20 billion per year in the EU.

Authorisation for approximately 4400 new clinical trials is given each year and, at any point in time, some 12 000 clinical trials are ongoing in Europe. But, worryingly, there has been almost a 15% decline in trials in the EU in recent years. Costs - resources and bureaucracy - have doubled and delays have increased by 90%. It is immensely important that we facilitate multinational clinical trials in Europe - 25% of EU trials take place in more than one Member State - not only to keep this innovative research in Europe but to guarantee state of the art cures.

There are several factors contributing to the decline of clinical trials in the EU, such as the commitment of industry to R&D, the relationship between industry and academic research, availability of investment or return on that investment. However, the bureaucracy of the process is clearly also one important factor.

So what can I as Commissioner for Health do to help? To start, the Commission can and will improve the regulatory framework and address concerns that have been voiced. We can do this by:

• Creating a simpler single portal for submission of clinical trials applications;
• Developing a faster, lighter system for assessments while maintaining patients' rights and safety and;
• Increasing cooperation between Member States.

• Ultimately, what guides us in our revision of the Directive is the best interest of patients! And, as parents, brothers, sisters or friends, this is of significance to us all.

For more information, please see the Clinical Trials page of the Directorate General for Health and Consumers:

http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm

On 11 October 2011, the European Commission adopted revised proposals on information to patients about prescription-only medicines. These proposals put the patient first. It is about their right to information. It is also about ensuring better, clearer, reliable and unbiased information. And information, as we all know, leads to empowerment!

The proposals set out for the industry exactly what and how information should be provided:

• The strict ban of any direct-to-consumer advertising is maintained and clarified. That means e.g. that industry must not use television, radio or general print magazines to push information to the patients.
• Industry will be obliged to publish certain information that is particularly important for patients, such as the labelling and the package leaflet;
• Other information can only be published after it has been approved by the responsible authority.

The proposals also provided me with an opportunity to strengthen the rules on pharmacovigilance - the monitoring of the safety of medicines on the market. These changes include:

• The automatic triggering of an examination at EU-level when a Member State takes action on a medicine due to serious safety concerns. This will ensure equal safety for patients throughout the European Union.
• When a company voluntarily withdraws a medicine from the market it must explain the reason. This is to ensure appropriate follow-up and to avoid that a withdrawal is not disguised as a commercial related action when it is in fact due to safety concerns.
• Authorised medicines that require special supervision by national authorities will be included in a publicly-available list of medicines.

The proposals will now be debated once more by both the European Parliament and by the Council of Ministers. I believe in these proposals and am confident that European patients - who will benefit from the changes - will too!

As consumers, what we eat is an important concern for EU citizens. It is crucial therefore to clarify – for consumers and for producers – the situation with regard to cloned animals and food production.

EFSA has confirmed that there is no evidence of food safety concerns regarding foods from cloned animals or their offspring. But there are other issues such as animal welfare that demand our attention. For example, cloned animals experience a number of health issues and a high death rate. Of course, these may disappear as cloning techniques improve over time. Notwithstanding, cloning plays an important role in preserving endangered species, in the production of medicines and for research.

Let me be clear. There is no cloning for food production in the European Union.

In the case of the offspring of cloned animals which are bred under the same conditions as sexually produced stock, there are no safety or animal welfare reasons to justify banning from the market place food originating from them.

Nevertheless, there are other issues which deserve examination such as the traceability of reproductive material (semen and embryos).

Therefore, the Commission has presented a proposal to temporarily suspend for five years:

• the use of the cloning technique in the EU for farming purposes;
• the imports of clones; and
• the marketing of foods from clones.

The proposal also recommends the setting up of a system to track the import of semen and embryos which would include information such as whether they stem from cloned animals or not. We will need to amend related zootechnical and animal health legislation which will allow farmers and industry to set up data banks.

Any decision we take in the future will have to be science-based and balanced and the suspension period will allow us the time to consider properly these issues. In parallel, advances will continue to take place in cloning techniques and the science available to us will continue to develop. This is good for consumers, good for science and last, but not least, good for the welfare of cloned animals.

I have participated for the first time in the well-known annual Gastein Conference where I had the opportunity to meet a wide range of health advocates, policy makers, as well as young researchers and industry representatives.

I was particularly keen to speak about "Health in Europe – Are we ready for the future?" and to exchange views on what Europe is doing today to ensure that our future generations enjoy health and benefit from the best possible healthcare.

I have my own ideal - or what you might call dream scenario - for the future of health. My ideal includes healthy ageing, less suffering from disease, healthcare for all….to name but a few. Probably the same dream that each and every EU citizen has. Of course, the difficult question is how do we get there? I believe prevention and innovation are the answers.

If Europe wants its citizens to be healthy, it must invest in innovation and technology for better diagnosis and care. E-Health for example, has the potential to save lives and provide access to diagnosis and care that would otherwise not be available. It has the potential to increase patient comfort and safety whilst at the same time making the delivery of health care more efficient and more sustainable.

We must however take the responsibility for our future into our own hands. No amount of technology will save us pain and suffering unless we make the right choices about what we eat and drink. We have the responsibility to instil this philosophy not only upon our own generation but upon future generations. Our youth need to realise that they cannot lead an unhealthy life and then expect to go on to enjoy a long and healthy retirement.

We certainly can't ignore the effects of smoking and obesity for example. Think about the illness and suffering they cause for individuals and the cost in healthcare spending for our governments. So, should we watch and do nothing? Or should we rather invest our efforts to dissuade people from smoking in the first place? The answer to these questions is clear. Investment in a smoke free today will show its return in a healthy tomorrow.

Our priority is to prevent diseases so that people live and age in good health; so that elderly citizens can be active and independent.

I am determined to do all I can to see a healthy future for all citizens, no matter where they live or how much they earn. The rewards are too high and too many to ignore: a better quality of life, a positive impact on our workforce and the competitiveness of Europe's health industry.

This is my dream for the future of healthcare in Europe and I am convinced that prevention is our best means of securing it.

• Speech: Towards a healthier future for all European citizens european health forum Gastein, 8th October 2010

On 28 September, I opened the Plant Health Conference in Brussels together with the Belgium Minister for Agriculture, Mme. Laruelle. The event was organised by the Belgian Council Presidency and the Commission, and is an important element for our reflection on the future of EU plant health legislation.

Protecting Europe's plants – our forests, gardens, trees and the landscape we know – is not an easy task and requires a variety of measures: strict controls to prevent insects and fungi for example from entering Europe from other continents; rapid action to limit outbreaks; the use of plant protection products and; resistant varieties of plants etc.

The challenge increases as pests and germs adapt and become resistant and plant protection products are phased out as we learn more and rework our policies according to new information on food safety and environmental concerns.

To give you an example, some recent threats from non-native insects include the outbreak of long-horned beetles from Asia which is threatening our maple trees and other broad-leaved trees and the arrival of Red Palm Weevil in Mediterranean Members States which is affecting palm trees.

The potential impact is not only economical but environmental as native trees are devastated changing the face of our landscape for the future.

Once new pests arrive and settle, there is often no way back. The EU plant health regime was developed in the 1970s and still is the cornerstone for agriculture, food security and environmental protection. Any new legislation will have to take account of climate change and the effect this will have on the spread of pests. This and other concerns for the future compel us to recognise that the current framework may not provide us with the optimum level of protection which is why, in 2009, an evaluation of the current regime was launched.

Events such as the Plant Health Conference are invaluable to the Commission and to me as they provide a direct source of input from stakeholders and Member State authorities. These contacts and the results of the evaluation provide a blueprint for a new EU plant health law which we will be developing over the next two years.

It is not only our duty but in our best interests to protect and guarantee the health of our plants. We have a lot of work to do but I am confident that with the support and cooperation of stakeholders, citizens and Member State authorities we will do a good job.

• http://ec.europa.eu/food/plant/index_en.htm

Last week I announced the results of the EU-wide sweeps on websites selling electronic goods. I am very proud as these results represent a success for the EU network of national enforcement authorities that carried out the sweeps, for European consumers and the business community alike. Overall, of 369 websites originally checked, 310 sites (84%) now comply with EU-wide consumer rules, compared with only 163 sites (44%) when these websites were first checked in May 2009. This means that consumers can now more safely operate on-line on these websites with the confidence that their rights are respected. I am looking forward to announcing equally good results next year when the sweeps on websites selling tickets for cultural and sporting events will be concluded.

As you may know, sweeps are enforcement actions led by the EU and carried out by national enforcement authorities. All Member States carry out simultaneous, coordinated checks for breaches in consumer law in a particular sector. After this initial check the national authorities contact the operators about the suspected irregularities and ask them to take corrective action. When necessary, the national authorities can also impose sanctions. The European Commission does not carry out the sweeps itself but plays a pivotal coordinating role.

The aspects on which websites can fall short of consumers' expectations often concern the presence of unfair contract terms, the provision of information about consumer rights, about prices, or about the contact details of the trader.

Thanks to the sweeps carried out by the enforcement authorities in the Member States, both consumers and businesses become more and more aware of EU consumer protection rules and the on-line environment improves to the benefit of all.

I am just back from Moscow, where on 13/09/10 I agreed, together with the World Health Organisation (WHO), on a joint Declaration committing the European Commission and the WHO to strengthening co-operation. I believe now more than ever, the time has come for the WHO and the Commission to join forces to address the many health challenges facing Europe today, in particular bridging health inequalities and fostering active and healthy ageing.

As the first European Commissioner to participate in such a gathering of the 53 WHO Europe countries, I am pleased to see that there is political will across the wider Europe to increasingly focus on prevention and on investing in health. I believe prevention of health problems is the pillar on which we need to build our health policy. We need to invest in prevention now. Prevention is our reserve for future delivery of healthcare.

The Declaration will enable us to plan, work together, share resources and deliver together on a joint agenda of innovation in health, fighting health threats, bridging inequalities and investing in health. I am convinced this will avoid duplication of efforts, create synergies and lead to more effective results.

I also met the Russian Health Minister to discuss co-operation between the EU and Russia on food safety and health. I have taken this opportunity to underline that the Commission is keen to deliver on the health aspects of the EU-Russia agreement and to raise two concerns. I expressed upon the Minister the need to ensure the flow of food products between the EU and Russia. In this context I stressed that a solution must be found to address difficulties for European dairy products and frozen poultry to be exported to Russia because of technical standards, which could be replaced by mutual recognition. I have also discussed with the Minister concerns related with the Russian law on pharmaceuticals, in particular as regards the level of protection of data submitted by a pharmaceutical company when requesting a market authorisation, and requirements on clinical trials.

I am convinced that my visit to Moscow has helped to foster a closer dialogue between Russia and the European Commission on food safety and public health which I intend to pursue actively in the coming years.

On 29 June I met an impressive gathering of over 500 health stakeholders from all over Europe and beyond. I had invited them to come to Brussels under the motto "Together for Health" to get their views and expertise on how to ensure that all policies play their part in improving citizens' health. My objective is to improve Health for all in Europe. To do this, many players and many policies need to work closely together.

Building synergies between policies and players is particularly important now that Europe is fighting a financial crisis. I believe investment in health means investment for sustainable economic growth. A population in good health means a strong workforce, long working lives and fewer healthcare costs. This is why the decisions we make now – on health action, on health budgets - will impact upon the health and welfare of our future generations. This is particularly important in the context of population ageing, which places even greater pressure on our health systems struggling to remain sustainable.

One way to improve healthcare and stem the rising healthcare costs in the long term is to use healthcare technology in a smart and responsible manner. e-Health applications for example, can help prevent diseases, increase patient safety and improve the efficiency of health systems. Medical devices also play a key role in the diagnosis, prevention, monitoring and treatment of diseases. New and emerging technologies and therapies, such as personalised medicines, can bring considerable benefits. I am convinced that Health technology can save lives and greatly improve healthcare. And this is the reason why we need to encourage responsible innovation in Health - which pays proper regard to efficacy, safety and risk, and benefits society.

However, what I would really like to see is a Europe where citizens are so healthy that they do not need that much healthcare in the first place. Many diseases which affect people are linked to what they eat and drink, and to whether or not they exercise or smoke. Europe needs to invest more – more time, more efforts, more money - in promoting good health. Promoting good health is not just about "convincing people" to take up healthy lifestyles or about awareness-raising campaigns. It is about ensuring that people can actually make healthy choices. And this is where the need for a wide range of policies to serve health concerns comes in.

For example, we may well advise people to exercise; but if there are no parks, no walking spaces, no bicycle lanes, people do not have the choice to exercise. We can only succeed in encouraging people to exercise if there are safe and clean spaces for them to do so. For this we need healthy urban planning and transport policies. Likewise, if we want our children to develop healthy eating habits, we need education policies that include nutrition in the school curricula; and we need schools that serve healthy meals. To be healthy, our citizens need to live in healthy conditions.

Therefore Health policy is also social policy; it is environment policy; it is transport policy; it is education policy; it is research policy; it is digital policy; and many other policies. That is why we need to work, truly, together for health.

On 12 March 2010 I visited the European Food Safety Authority (EFSA) in Parma, Italy. It was my first visit to EFSA since I took over the Health and Consumer Policy portfolio on February 10th.

I met with EFSA's management and with experts from the Authority's Scientific Committee. During the meeting I was briefed about EFSA's work and recent activities on a series of ongoing, and often complex, issues that concern European consumers – issues such as GMOs, cloning, nutrition labelling (such as health claims) and nanotechnologies. I highlighted the importance of co-operation between the Authority and the competent Commission services and the scientific co-operation between EFSA and the Member States.

I firmly believe that safety is the most important ingredient in food and must continue to be our guiding and pervasive principle. I am also proud to note that Europe enjoys the finest and most comprehensive food safety system in the world.

EFSA is an integral partner in our efforts to ensure food safety and has now established itself as a well-respected authority, recognised for the quality of its scientific work.

• Commissioner Dalli delivers speech at the WHO Fifth Ministerial Conference on environment and health
• Commissioner Dalli visits the European Food Safety Authority (EFSA)

Last Friday I went to Parma in Italy to participate in the WHO Environment and Health Conference. I attach great importance to this environment and health process which brought together so many Ministers, officials and civil society to Parma. Let me tell you why.

Environmental factors can have a significant effect on citizen's health and the development of diseases. And vulnerable groups, such as children and socially disadvantaged people, can be particularly affected by such factors. This is why developing healthy environments for all our citizens must be at the heart of all our policies. We need to act to reverse the negative impact of the environment on citizens' health.

I fully welcome the key priorities agreed at this conference in the areas of climate change and socioeconomic and gender inequalities. I am particularly pleased that the Conference Declaration agreed in Parma focuses on the most vulnerable groups in society. I believe the Declaration will guide us in our efforts to progress on environment and health in Europe for the years to come. And the challenges to tackle are many. Let me give you just one example: the incidence of asthma and allergy is increasing in Europe. Some 80 million Europeans suffer from allergies; 30 million from asthma. One in every 5 children now suffers from a chronic respiratory condition. This means more suffering for those children, and more need for healthcare. We need to act.

At EU level, I will continue to tackle environment and health challenges through the Action Plan on environment and health. At global level the European Commission is fully committed to working with governments, civil society and international organisations, in particular the World Health Organization, to support the goals set out in the Parma Declaration.

• Commissioner Dalli delivers speech at the WHO Fifth Ministerial Conference on environment and health