APRIL 2010

World Asthma Day 4th of May is approaching...

EFA involved in U-BIOPRED project on understanding severe asthma better. EFA is a partner in an EU research project on severe asthma the U-BIOPRED (Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes). The five year project is part of the so-called Innovative Medicines Initiative (IMI), a public-private partnership between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA), which funds projects withthe aim of combating causes of delay in development of medicines. U-BIOPRED brings together patients organisations, bio-pharmaceuticals enterprises, small and medium enterprises, the European Medicine Agency, and academic institutions. It aims at improving understanding of severe asthma, its diversity, and the history and progression of the disease. Better understanding will help to develop more targeted treatments for people with severe asthma, which fits perfectly with the global theme of WAD: launch of a campaign by Global Initiative of Asthma to reduce asthma hospitalizations by 50%.

EFA is contributing to U-BIOPRED and representing patients within this project together with Asthma UK and Netherlands Asthma Foundation through involvement in consensus, ethics and dissemination and training work packages and by giving opportunities for members involvement in providing patient perspective. Stay tune on the progress in this newsletter and the Project website will be available this spring.
Breda Flood, EFA leader in U-BIOPRED
Link to World Asthma Day: http://www.ginasthma.org/WADIndex.asp

EFA becomes a full member of European Medicines Agency Patients and Consumers Working Party

In March 2010 EFA became full member of the Patients and Consumers Working Party (PCWP) at the European Medicines Agency (EMA). The EMA is a decentralised body of the European Union responsible for the scientific evaluation of applications and safety monitoring for European marketing authorisation for medicinal products. The Agency also plays a role in stimulating innovation and research in the pharmaceutical sector and gives scientific advice to companies for the development of new medicinal products.

The Patients and Consumers Working Party (PCWP) was created to provide recommendations to the EMA on all matters of interest to patients in relation to medicinal products. The PCWP contributes in helping adapting information provided by EMA to the needs of patients and consumers. It helps to develop appropriate communication tools between the agency and patients and consumers, contributes to increase awareness of patients in relation to the good use of medicines. It also gives general advice in relation to product specific matters – experts from relevant organizations take part in Scientific Advisory Groups meetings when requested. In this framework EFA has delegated experts for the quality review of Patient Information Leaflets of medicines (PILs) and European Public Assessment report (EPARS are documents which provide a summary of the grounds for the EMA scientific opinion on granting a marketing authorisation for a medicine.)
Lina Buzermaniene, EFA EMA Coordinator and representative at EMA PCWP.
For more information: http://www.ema.europa.eu/Patients/PCWP.htm

EFA at the WHO Europe " Fifth Ministerial Conference on Environment and Health 10-12 March

The theme of the Conference was “Protecting children’s health in a changing environment”. Health and environment ministers from 53 countries, and the European Commissioner for health and consumer policy, Mr John Dalli were present.EFA was represented by Sandra Frateiacci and Giorgio Salerni from FEDERASMA, within the group of the Health and Environment Alliance (HEAL) participants. They attended a seminar on ‘Indoor air quality in Europe-Preventing and reducing respiratory disease’, as well as the Plenary Session.

The Parma Declaration on environment and health was adopted. It sets targets for the member countries of the WHO on access to safer water and sanitation, for physical activity and healthy diet in order to fight obesity. They also committed to ensure improved outdoor and indoor air quality.Mr Dalli also mentioned allergy and asthma, and said that "we need to act".

To read Giorgio Salerni’s full report on the Conference: click here.
To read a report on the Conference by HEAL: click here.
To access WHO Europe Parma Conference website: click here.
Giorgio Salerni, FEDERASMA, www.federasma.org

Know your air for health website: Available in two more languages!

The joint EFA and Health and Environment Alliance (HEAL) “Know your air for health” websiteis now available in Frenchand Czechin addition to English, Finnish, Italian and Lithuanian. It gives information on national and local air pollution, as well as on health effects, and on European legislation related to air quality. It is aimed at raising awareness about air pollution and its effect on health, and providing targeted information for people with respiratory diseases. We are looking for experienced volunteers to translate the Website in further languages. Please contact info@efanet.org. Warm thank you goes to EFA members who have helped us thus far.

EU food allergen labelling update: EFA's actions, and vote in ENVI committee

Following our article on this topic in March issue of this e-zine, EFA sent a policy brief on “the Commission proposal on provision of food information to consumers” for members and an explanatory document on the issues for people with food allergy and hypersensitivity, testimony and a letter to the members of the European Parliament (MEPs) of the Environment and Public Health and Food Safety Committee (ENVI). Our objective was to raise awareness about food allergies, and express concern about the risk of watering down the proposal. EFA also advocated for a regulation of precautionary “may contain” labelling and for the necessity of putting in place a safety chain for food allergens, just as is currently in place for hygiene. The letter also called for clear labelling of non pre-packed food and of changes of recipe in case of allergens.

The draft report was adopted by the ENVI Committee after considering 800 amendments. It recommends giving up the 3mm minimum font size that EFA supports. For non prepacked food, an amendment proposes that a sign will be placed in the sale area to indicate that food allergen information is available on demand but unfortunately also warning that cross contamination cannot be avoided. However another amendment proposes to make it compulsory to indicate food allergen on the package for food chains serving standardized food. The report of the ENVI committee is now scheduled to be discussed in plenary session at the European Parliament at the end of May 2010 and EFA together with our Food Allergy Working Group of Members will follow up.
Link toEFA letter to Members of the European Parliament of the Environment and Public Health and Food Safety Committee
Link to testimony of a patient with severe food allergy

EFA member news: Italian COPD Patient Association, events and activities in May 2010

In May, Associazione Italiana Pazienti BPCO is organising ‘Breathe Day’ - Festa del Respiro, a local initiative of their member associations in Manziana and Frascati in Rome. The objective is to improve respiratory health by offering free breathing test for the Public.
www.pazientibpco.it

EFA member news: FFAAIR Walking Race against COPD

The national campaign “walking Race against COPD” has been launched on the 31st of January in Marseille, France. The aim is to call public attention to COPD and to explain the meaning of this term and the burden of COPD. Each month during 2010theFFAAIRcaravan will go to a different French city for one day. The caravan proposes to measure the respiratory function and the pulmonary age and to take part in the northern walking race. Around 300 persons have measured the age of their lungs and 6 sessions of northern walking have been organized in Parc Borely in Marseille. This campaign had the same success in Grenoble on 28th of March. We are sure that this campaign will raise awareness of COPD and improve the possibilities of prevention and diagnosis.  http://www.ffaair.org/

European Medicines Agency launches Public consultation on its Road Map to 2015

In January 2010 the European Medicine Agency (EMA) made available the draft of its road map “The Agency’s Contribution to Science, Medicines and Health” for a public consultation which will last until the 30th of April. It sets out the Agency’s long term strategy taking into consideration the main drivers for change and the future challenges. The three strategic priority areas proposed are:  addressing public health needs, facilitating access to medicines, and optimising the safe use of medicines. It sets objectives for future action, notably taking into account patient experience to improve decision-making through and the safe use of medicines involving patient organisations. The EMA also intend to take into account the demands for more transparency through giving more information targeted for users such as patients.
After the consultation the EMA will publish a new document “From vision to reality”, taking into account responses. EFA is going to respond to the consultation, and members will have an opportunity give feedback.
For more information:http://www.ema.europa.eu/htms/general/direct/roadmap/roadmapintro.htm

Information to patients and the EU update

In 2008 the Commission made a proposal on information to patients/public on prescription-only medicines. The proposal aims at 'improving and harmonizing provision of non promotional high quality information on prescription only medicines' to European patients. Rapporteur Christian Felljner drafted two reports that are to be discussed in June in the Environment, public health and food safety (ENVI) committee of the European Parliament. Essentially he proposes to shift the focus on giving industry the right to provide information into patients’ right to have access to information and for patient groups to have a firm role in this.

The European Patients Forum (EPF), of which EFA is member, worked regularly on this topic from the consultation process to call for a proper comprehensive “information to patients” strategy, including access to quality information on medicines by the European Union. This request is now proposed by Fjellner to be included. EPF documents on this topic including consultation answers and position papers can be found here.

In addition, the European Medicine Agency launched a public consultation on the 23 of February on the revision of the product information for medicines’ package information leaflets for patients. It aims at making the leaflet requirements more flexible and to improve information for example on the balance of benefits and risks. The proposal and template for consultation can be found here.  

Europe 2020: a new economic strategy for smart, sustainable and inclusive growth

On the 3rd of March the European Commission launched the Europe 2020 strategy proposal. It aims at getting Europe out of the economic crisis, and at preparing the economy for the next decade through 3 key drivers and seven flagship initiatives. The first objective is “Smart growth through fostering innovation, enhancing performance of European education system, and making Europe a digital society. Secondly it puts green growth and competitiveness at the heart of the strategy with “Sustainable growth” as a priority. The last key driver is “inclusive growth”, with two proposed initiatives: an agenda for new skills and jobs aimed at modernizing European labour market, and a “European platform against poverty” to ensure more social cohesion, including reducing health inequalities.

To measure progress, the strategy sets 5 headline quantitative targets at EU level: 75 % of the population aged 20-64 should be employed (instead of current 69%), 3% of the EU's GDP should be invested in research and development, meeting the so-called "20/20/20" EU climate/energy targets,  reduce the percentage of early school leavers under 10% while increasing the percentage of young adult with diploma to 40%, and  lifting 20 millions of European out of poverty. Member States will be asked to translate them into national targets. Health is invisible and unfortunately not identified as a key driver.
Source: European Commission press release.

World No Tobacco day 31st of May 2010

In 2010 the theme will be “Gender and tobacco with an emphasis on marketing to woman”. Indeed, as the number of men smoking is peaking, the rate of women smoking is on the rise, as well as the prevalence of tobacco use among girls. Therefore the WHO will call on governments to make particular efforts to protect women from marketing campaign aimed at luring them into smoking, and will reassert the WHO framework convention’s recognition of the need for  gender specific measure in tobacco prevention, as well as for full participation of women in policy making and implementation related to tobacco control.

The World No Tobacco day is a yearly celebration created in 1987 by the Word Health Organization, and it is aimed at informing the public of the dangers of tobacco and at drawing attention to the epidemic and its preventable lethal consequences. It also promotes adherence to the WHO Framework Convention on Tobacco control.
Source: WHO smoke free initiative webpage                                               http://www.who.int/tobacco/wntd/2010/announcement/en/index.html
To register your World no Tobacco day event 2010:
http://www.who.int/tobacco/wntd/2010/registration_form/en/index.hrml

EFA in meetings in March

Since our last eZine, EFA was represented in the following conferences and meetings: A conference organized by the European Generic Medicines Association on “How a sustainable Generic Medicine industry provides Long Term Healthcare Solution”, the European Network for Smoking Prevention’s General Assembly, the meeting of the EMA Working Party of Patient and Consumer Organisations and another ad hoq meeting at the EMA. EFA Board Member Lina Buzermaniene spoke at Innovative Market Access Strategies for Medical Devices & Technologies Conference in Budapest on ‘EFA advocacy on clear and equal reimbursement decisions in Europe’.

EFA Conference is approaching and its not too late to sign up!

To view the Programme click here,
To register click here,
For Local information on the city of Vilnius click here.