New leaders of the European Institutions
We left you before the summer break with updates on the composition of the new European Parliament coming out from the elections of May 2014. As from July, interesting developments took place at the European Parliament. 
Martin Shultz (Socialists and Democrats, Germany) was re-elected as the European Parliament’s President for the next 2.5 years. In addition, 20 Committees were formed and their chairs elected. The info graphic on who is who at the EP can be found here. Taking into account EFA’s activity sector, one of the most important influence groups is the Committee on the Environment, Public Health and Food Safety (ENVI). Formed by 69 members (the full list of members can be found here), ENVI will be chaired by: Giovanni la Via – chair (European Pepople’s Party, Italy) Benedek Javor – vice-chair (Greens, Hungary) Daciana Octavia Sarbu – vice-chair (Socialists and Democrats, Romania) Pavel Poc – vice-chair (Socialists and Democrats, Czech Republic) Gilles Pargneaux – vice-chair (Socialists and Democrats, France) Meanwhile, Jean-Claude Junker (European People’s Party, Luxembourg) was elected by the European Parliament as the next European Commission President. Moreover, Member States have started to nominate the Commissioners for the new college to be voted in October 2014, and although negotiations are still ongoing, the final college might look like this.
EFA response to mobile health (mHealth) consultation
From April to July 2014, the European Commission held a public consultation on mHealth to obtain insight, support and basis for the implementation of mHealth policies in the EU that is planned to be announced in 2015. EFA took part in the consultation to make sure that the interests of asthma, allergy and COPD patients are taken into account for the development of EU mHealth policies. In our contribution we highlighted that while mHealth has a great potential to empower patients and to reduce healthcare costs, there are key issues that need to be resolved before a standardised implementation of mHealth solutions:
(1) data used in mHealth apps is personal and sensitive, therefore its use should be regulated by advanced legislation; (2) mHealth applications should be monitored by competent authorities to make sure that they are safe to use; (3) research and tests of mHealth applications should involve patients to maximise these apps’ usefulness. The complete response is available here. The results of the consultation and the feedback report will be issued by the Commission in the fourth quarter of 2014.
EFA response to the European Commission consultation on food allergy
From May to August 2014, the European Food Safety Authority (EFSA) conducted a public consultation on the draft Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes. This document updates previous EFSA opinions on food ingredients and substance with known allergenic potential mentioned in Annex IIIa of the Directive 2003/89/EC (future Annex II of Regulation (EU) 1169/2011, set to enter into force as for December 2014). The draft Scientific Opinion includes information on the following topics:
- prevalence of food allergy in unselected populations;
- proteins identified as food allergens;
- cross-reactivities;
- effects of allergenic food processing on allergenicity of foods and ingredients;
- methods for allergens and allergenic foods detection;
- doses observed to trigger adverse reactions in sensitive individuals;
- approaches which have been used to differentiate individual and population thresholds for selected allergenic foods. Despite the fact that motivations behind the request of the draft Scientific Opinion were very positive, EFA suggested that some other developments are still necessary to make it more advanced and corresponding with food allergy patients’ needs.
The developments proposed in EFA’s contribution to the consultation are the following: (1) Usage of the most recent research data, as some studies underpinning the opinion are old and outdated; (2) Greater focus on food allergy patients, as the opinion does not considers patients’ requests and does not focus on the quality of life aspect, thus it does not result in policy change; (3) Proposal of clear definitions on thresholds, foods safety, risk and benefits of unintended ingredients label, and severity of possible allergic reactions; (4) Consideration of allergens labelling as a crucial aspect for a good management of food allergies, as it allows allergy patients to be fully aware of the choices they make; (5) Official specification of the relevant method of analysis for detecting each allergen in food. Currently, the methods of detection vary from actor to actor, which leads to the risk of getting different results. Consequently, if methods are clearly defined, this risk is diminished and consumers feel more protected; (6) In a short term, precautionary labelling could possibly be used only as an ultimate solution after the implementation of best-practices to avoid cross-contamination (e.g.: allergen management as part of hygiene/safety manual, responsibility of food business operators at each step of the distribution chain). In the long term, EFA is aimed to abolish precautionary labelling as it often leads to unnecessary consumers’ confusion and restrictive diets; (7) Establishment of thresholds to maximise consumers’ safety.
The full response of EFA and other stakeholders will be published by EFSA in the coming months. We kindly thank EFA Food Allergy Working Group members for their great contributions and support.
EFA becoming active in the Transatlantic Trade and Investment Partnership Agreement (TTIP) discussion
In June 2013, the European Commission started negotiations on the Transatlantic Trade and Investment Partnership Agreement (TTIP) with the United States (US). The agreement is aimed to remove trade barriers in a wide range of economic sectors to make it easier to buy and sell goods and services between the European Union (EU) and the US. Although this agreement may have the potential to benefit European citizens, and patients in particular (e.g. through additional harmonisation between the European Medicines Agency (EMA) and the US Food and Drug Administration), many consumer organisations, Members of the European Parliament, trade unions and health groups have expressed their concerns. From the patients’ perspective, TTIP may lead to the following issues:
- Consumer, health, and environmental regulations could be challenged as violations of “investor rights” by companies. This can be a huge deterrent, especially for smaller countries, to pass legislation to protect consumers, public health and the environment;
- Risk of harmonising by levelling down: reduction of EU higher standard to adapt to US ones, especially as regards environment (e.g.: watering down fuel efficiency standards for cars and EU rules on toxic chemicals), health (e.g.: limitation to tobacco control policies, clinical trials and medical devices regulations on transparency) and consumer protection (e.g.: import of meat/poultry treated with veterinary drugs) legislations;
- Focus on medicines: increased intellectual property right protection and enforcement resulting in danger for EMA new policy on publication of clinical trials results and the newly adopted EU regulation on clinical trials and less innovation in drugs, risk of higher prices of medicines to guarantee innovation and face global competitors, slowing down medical devices access to market.
Driven by the described concerns, EFA expressed its support to the European Public Health Alliance (EPHA) in its response to a public online consultation on investor protection in TTIP, conducted by the European Commission from March to July 2014.
New online pharmacy logo
More and more Europeans buy medicines online and at the same time the phenomenon of falsified medicines is on the increase globally, with more and more medicines now being falsified. To ensure safety of its citizens, the European Union has approved the new Directive on falsified medicines (2011/62/EU), which came into force in January 2013. The Directive aims to prevent falsified medicines entering the legal supply chain and reaching patients while strengthening current controls and introducing new measures. One of the Directive’s milestones – a new logo for online pharmacies – came into force end July 2014 and Member States have one year to prepare for its application. The logo is common for the European online pharmacies and it is used to prove retailed medicines authenticity and safety. By clicking on the logo, a costumer will be taken to his/her national regulatory authority website, which lists all legally operating online pharmacies and other legally authorised retailers of medicines. If the retailer is not listed in the list, a risk of buying falsified medicines increases. The Directive on falsified medicines also foresees that Member States conduct campaigns to raise awareness of the logo and the dangers of falsified medicines.
New EMA policy on Clinical Trials
Current EU clinical trials legislation has been criticised for being burdensome, expensive and highly divergent between the 28 EU Member States. For example, both ethnical review and regulatory authorisation of clinical trials are competencies of Member states, thus if a clinical trial is to be run in more than one country, it requires a separate assessment in each of the countries. As a result of the dissatisfaction with the existing clinical trials regime, the European Commission reported a 25% drop in the number of trials conducted in Europe from 2007 to 2011. The new regulation (Regulation 536/2014), which will become applicable in 2016 and will apply only to trials conducted in the European Union, is aimed to improve the existing clinical trials system by standardising it while maintaining high standards of patient protection. One of the greatest changes in the new rules will be in relation to clinical trials data transparency. The European Medicines Agency (EMA) has recently proposed a new policy regulating the publication of clinical trial data: by establishing a database that will store and make available information on clinical trials. The main principle is that all data will be publicly available unless there are adequate reasons to keep confidentiality (e.g. personal data protection). Possibility to download, save and print the trial data for academic and non-commercial research purposes is also foreseen in the proposal. EMA has also adopted a revised process for assessing the eligibility of patients’ and healthcare professionals’ organisations to provide them with input on general issues related to medicines. This process allows the Agency to identify the most appropriate organisations acting in the interests of European civil society. The eligibility criteria have been updated to align with increased transparency requirements, in particular on sources and level of funding and a code of conduct on their relationship with pharmaceutical industry. EFA continues to be part of these organisations and provides the perspective of patients with allergy, asthma and COPD.