EMA adopts implementation plan for its 'Road map to 2015'

The management board of the European Medicines Agency (EMA) has adopted a new document entitled "Implementing the European Medicines Agency's Road map to 2015: The Agency's contribution to Science, Medicines, Health; From Vision to Reality". The implementation plan follows the adoption in December 2010 of the EMA Road map to 2015, and sets out how this is expected to be developed. Both the Road map and its newly adopted implementation plan focus on optimising EMA's performance in 3 strategic areas: addressing public health needs, facilitating access to medicines, and optimising their safe and rational use. To tackle the first area - public health needs - gaps in medicine development will be looked at, as well as how best to respond to new and emerging scientific developments, among other things. The second aim of facilitating access to medicines will be achieved through actions which include increasing the focus on medicine development processes. Finally, the goal of optimising the safe and rational use of medicines is to be achieved by increasing the focus on patient safety, and improving information and communication tools for stakeholders.

EZINE ARCHIVE

January 2012 eZine

HAPPY NEW YEAR from the whole EFA team! Landmark development in EU policy: Council adopts conclusions on chronic respiratory diseases in children The Council of the European Union, which represents EU Member States, has unanimously adopted conclusions at ministerial level on "prevention, early diagnosis and treatment of chronic respiratory diseases in children". These conclusions are now translated in all the 23 official languages of the European Union and available here, by following the link and selecting the language required. Although the conclusions are not legally binding they represent a political milestone for the recognition of chronic respiratory diseases as a crucial health problem. This political recognition at the EU level of the burden caused by chronic obstructive diseases is of fundamental importance for EFA. By inviting MSs to take into consideration chronic obstructive diseases in national, regional and/or local health programmes and with the objective of increasing public awareness, these draft conclusions address EFA's concerns and will help to achieve its aims. The draft conclusions are a consequence of the experts' conference organised by the EU Polish Presidency on the "prevention and control of children asthma and allergy in EU from public health point of view: urgent need to fill the gap," held in Warsaw-Ossa (Poland) on the 21st-22nd of September 2011. For further information, please contact Roberta Savli, EFA EU Policy and Project Officer This email address is being protected from spambots. You need JavaScript enabled to view it. Council of the European Union, which represents EU Member States, has unanimously adopted conclusions at ministerial level on "prevention, early diagnosis and treatment of chronic respiratory diseases in children". These conclusions are now translated in all the 23 official languages of the European Union and available here, by following the link and selecting the language required. EFA News: Launch of EFA Respiratory Allergy Book at European Parliament On the 22 of November, EFA marked the launch of its new book on respiratory allergies. The event took place at the European Parliament in Brussels. EFA News: Launch of EFA Respiratory Allergy Book at European Parliament On the 22 of November, EFA marked the launch of its new book on respiratory allergies. The event took place at the European Parliament in Brussels. The aim of the EFA respiratory allergy book is to draw attention to the dramatic increase in allergies that is taking place. Approximately 20%-30% of the world's population are affected by some form of allergic reaction. Respiratory allergies are the most common allergies both in Europe and worldwide and it is estimated that by 2015 1 in every 2 Europeans will suffer from an allergy. Despite this, awareness of the issue remains low and patients are often the first to ignore their condition. The new EFA book has gathered a wealth of information on the state of allergies across the EU. It reveals the urgent need for increased awareness of respiratory allergies, and highlights the loopholes and inequalities which are affecting many European patients. The book includes a Call to Action asking governments and the EU to recognise allergy as a real and serious disease, promote national programmes to raise awareness, prioritise the prevention, management and control of allergy, encourage training of healthcare professionals, adapt healthcare and reimbursement policies for patients and improve air quality. Proactive allergy programmes which take the above into account will reduce the burden of the disease, financial and otherwise, on individuals and society. The event gathered MEPs, EU officials, representatives of the Polish Presidency of the EU and patient and medical representatives to address this major health challenge, and was particularly supported by MEP Ms Elisabetta Gardini, who hosted the event. EFA warmly welcomes its member to sign the EFA Call to Action, and is currently collecting signatures. For more information contact This email address is being protected from spambots. You need JavaScript enabled to view it. Press release EFA News: 2nd EFA COPD Workshop held and policy recommendations launched on eve of World COPD Day 2012 Following the success of the 1st EFA COPD Workshop focussing on prevention and diagnosis held in June, a 2nd Workshop was held on November 9th in the European Parliament in Brussels. This time the focus was on COPD care and research needs. The event gathered COPD patients, MEPs, representatives from the European Commission and the Polish EU Presidency, as well as partnering health NGOs. It was co-hosted by MEPs Sean Kelly and Karin Kadenbach. The workshop first heard from patient and employer representatives who explained how living actively and working with COPD is possible, but depends on adequate access to therapy and health systems which support patients' (and therefore also employers') real needs. The high cost of caring for patients who experience exacerbations was highlighted, and the importance of developing individualised patient strategies to reduce exacerbation rates was therefore stressed. A Finnish health representative then described how Finland has pioneered best practice in the field, and has succeeded in lowering COPD costs and improving care through a series of awareness raising measures and better allocation of resources. More research on COPD issues was called for, particularly regarding the causes of exacerbations in patients and the under-explored link between COPD and depression and its resultant effects on patients. It was unanimously stressed that awareness of COPD remains unacceptably low. EFA President Breda Flood said she hopes that the conclusions of the two workshops will prompt concrete action in the European Parliament, specifically an 'own-initiative report' urging the European Commission to take action. The conclusions of the two workshops were launched by EFA on November 15, the eve of World COPD Day 2011. EFA called upon the EU and its member-states to implement the recommendations as soon as possible, to prevent, as it said 'an average estimate of 10 percent of Europeans from suffocating over the next decade.' EFA COPD policy recommendations EFA News: Former President of EFA speaks at World COPD conference in Shanghai The Second World Conference of COPD Patient Organisations was held in Shanghai on 6-7 of November. The conference was organised by the International COPD Coalition (ICC), a not-for-profit body composed of patient organisations from around the world working to improve the health and access to care of patients with COPD. Former EFA President Marianella Salapatas represented EFA at the conference. Throughout the 2-day event - which generated significant media attention and gathered high-level government representatives including the Chinese Minister for health - topics included the role that governments and health ministries have to play in combating COPD, the future of COPD patient organisations, lessons in advocacy, collaboration between organisations and recent medical advances in COPD. In a session entitled 'COPD Patient group advocacy: global lessons', Marianella described EFA's experience of advocating for COPD patients at EU level. Her presentation, entitled 'COPD in Europe - Past, Present, and Future', mentioned several of the initiatives EFA has taken to raise public and political awareness of COPD, including the EFA book on COPD in Europe, the Call to Action on COPD and EU projects it has taken an active role in. She stressed that the most important role of patient organisations in advocacy is to ensure patients' voices are heard. Also released at the conference was a summary of the new 'GOLD Strategy for the Diagnosis, Management and Prevention of COPD'. The document was adopted at the conference on November 7th, and GOLD, which is in charge of global COPD guidelines, indicated that the final version would be available soon on its website. EU News: Polish Presidency conference on inequalities in healthcare held On the 7-8 of November in Poznan, Poland, the Polish Presidency of the EU organised a conference entitled 'Solidarity in Health. Closing the health gap between European Union States'. The aim of the conference was to highlight the importance of solidarity in the healthcare field for European Member States, and to set out measures to decrease the inequalities that already exist between them. Differences in standards of care and treatment - for example between eastern and western Member States - are not only at odds with the values of the EU, but they take a significant financial toll which in turn serves to deepen the divide. Closing this unequal 'health gap' is one of the two main priorities of the Polish Presidency. The conference was attended by representatives of Health Ministries of EU Member States, European Commission representatives, representatives of the European Centre for Disease Prevention and Control (ECDC) and of the World Health Organisation (WHO). Breda Flood, EFA President, attended the event, which included a session on 'prevention and control of childhood asthma and allergy in EU from the public health point of view'. More information Programme EU News: EMA adopts implementation plan for its 'Road map to 2015' The management board of the European Medicines Agency (EMA) has adopted a new document entitled "Implementing the European Medicines Agency's Road map to 2015: The Agency's contribution to Science, Medicines, Health; From Vision to Reality". The implementation plan follows the adoption in December 2010 of the EMA Road map to 2015, and sets out how this is expected to be developed. Both the Road map and its newly adopted implementation plan focus on optimising EMA's performance in 3 strategic areas: addressing public health needs, facilitating access to medicines, and optimising their safe and rational use. To tackle the first area - public health needs - gaps in medicine development will be looked at, as well as how best to respond to new and emerging scientific developments, among other things. The second aim of facilitating access to medicines will be achieved through actions which include increasing the focus on medicine development processes. Finally, the goal of optimising the safe and rational use of medicines is to be achieved by increasing the focus on patient safety, and improving information and communication tools for stakeholders. EU News: EFA at EMA meetings On 30th November EFA board member Lina Buzermaniene and EFA COPD advisor Michael Wilken took part in the Patients and Consumers Working Party (PCWP) meeting at the European Medicines Agency (EMA), which gathered those eligible to work with EMA. Guido Rasi, new EMA executive director, introduced himself and expressed his positive view on patient involvement in health policy. A general update on the implementation of the new pharmacovigilence legislation, which will allow patients to directly report adverse reactions, was provided. Patients and consumer organisations were consulted on the medicines which will be under additional monitoring and how this could be communicated on package leaflets. Further legislation introduced in the pharmaceutical field was also discussed, including information on the anti-falsification legislation. A WHO report in 2006 stated that globally, 10% of medicines may be falsified and 50% of falsified medicines are bought on the internet. This problem is associated with weak regulatory systems and legislative measures will be taken, like provisions for import of active substances, safety features, good distribution practise, more security for internet sales etc. A representative of the European Commission presented a proposal for legislation on information to patients, which is described below. EU News: Commission issues new proposals for public information on prescription-only medicines The European Commission has recently issued revised proposals clarifying the information that industry should make available to the public on prescription-only medicines. This follows a revision of its earlier proposals on the subject, rejected by the European Parliament in 2010. The new version attempts to incorporate Parliament's requests, and, according to the Commission, has the overall objective of empowering patients and promoting the rational use of medicines by ensuring that industry provides good quality and objective information on all prescription-only medicines. The new proposals uphold the current ban on the advertisement of prescription-only medicines. They foresee that only certain information on the medicines in question will be allowed, and that this information will only be allowed through limited channels of communication which fulfil specific quality criteria. The revised proposals also seek to further strengthen the current system for monitoring the safety of medicines, which is known as pharmacovigilance. Press release More information EU News: Stakeholder workshop on Indoor Air Quality held in Brussels In October in Brussels, Foundation Euractiv held a stakeholder workshop entitled 'The air we breathe - from regulatory patchwork to coordinated EU action?' in Brussels. The aim of the workshop was to discuss the possibility of legislating to improve the quality of indoor air in the EU. Although outdoor air quality has long been a focus of EU policy makers, Indoor Air Quality (IAQ) is only inconsistently legislated for at EU level. Nevertheless, recent research has found that a greater proportion of pollutants are now to be found in indoor environments. The urgency of acknowledging this is further increased when it is taken into account that Europeans are spending more time (on average 80%) indoors, and that the quality of indoor air has deteriorated as insulation in buildings has been reinforced in recent times. Participants at the event - who included representatives of the European Parliament and Commission, as well as health and patient associations, among others - discussed whether or not there is room at EU level for further legislation on Indoor Air Quality, and if so, what benefits and implications this could have. Susanna Palkonen, EFA Executive Officer, represented EFA at the event and stressed that the biggest issue at the moment is the lack of a coherent strategy for ensuring good Indoor Air Quality in the EU, whether this be in the form of legislation or otherwise. Video Clip Other News: News from the EFA COPD working group The EFA COPD working group held a teleconference on December 7th. All EFA members dealing with COPD are invited to become active members of this group. Contact This email address is being protected from spambots. You need JavaScript enabled to view it. Other News: Upcoming COPD partners meetings 2012 EFA will have a COPD partners meeting on January 19th, and then an all-partner meeting on March 12th. Both meetings will be held in the EFA offices in Brussels. For more information contact This email address is being protected from spambots. You need JavaScript enabled to view it.

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