EMA Patients’ and Consumers’ Working Party
In the last Patients’ and Consumers’ Working Party meeting that took place in London on September 16, EFA, represented by Lina Buzermaniene, was pleased to witness that the European Medicines Agency (EMA) will involve patients into the Committee for Medicinal Products for Human Use (CHMP) work after several formal requests from patient organisations. For the time being, patients involvement into the CHMP will be pilot, as they will be invited to CHMP meetings on a case by case basis. During the meeting, EMA also presented two other pilot projects currently ongoing. The first, Adaptive licencing project, is a new approach to the authorisation of human medicines - early authorisation of a medicine in a restricted patient population under restricted conditions, followed by phases of evidence-gathering and the adaptation of the marketing authorisation to allow broader patient populations to access the medicine. This is particularly relevant for medicines with the potential to treat serious conditions where there is an unmet medical need.The second, EU collaboration on patient registries, is not evolutioning as expected as common protocols for data sharing are missing, as well as scientific methods and data structures; there is a lack of data sharing and transparency, difficult to assess the validity of results from individual PRs, on-going national and EU initiatives on registries are not well coordinated and sustainability remains uncertain. The good news is that a task force to develop and test an EU collaborative framework on patient registries will include patients’ representatives. Finally, pandemic preparedness was dicussed, with specific emphasis on the influenza quality model guidelines published in May, the non-clinical/clinical module published for consultation in July, and the procedural guidelines that will be open until the end of 2014 for consultation.
EUPATI Roundtable
On Friday the 12th of September, EFA participated at the European Patients Academy on Therapeutic Information (EUPATI) round table in Brussels to discuss best practice guidelines of interaction between patient representatives and ethics committees. 
The meeting served to share best practices from both the patients’ and ethics experts’ side, to inform participants on different existing ways for patient involvement in ethical reviews. Patients’ contributions to ethical reviews are considered as very positive although limits remain to patients’ participation, regarding the expertise required and the technical knowledge. By exploring different models existing throughout Europe, participants discussed the principles that should apply to ensure patients’ involvement in national ethical bodies with views to implementing the new clinical trial regulation. Given the scope, complexity and specificity of certain procedures regarding ethics, further debate is needed to determine clear opportunities and guidelines for national-level patient involvement in national committees.
Innovative Medicines Initiative 2 Open Info Day
On 30th of September, EFA attended the Innovative Medicines Initiative 2 (IMI2) Open Info Day in Brussels. During the morning session European Commission officials and industry and representatives provided their perspective on the current focus trends in medical research; the move from scientific challenges and publications towards health-related challenges and unmet medical needs. The Commission clearly emphasized the importance of (societal) impact, which can be reflected in IMI 2 calls. This was followed by clarifications on the IMI2 call procedures.
Other meetings
Susanna Palkonen also attended the EPF board meeting and funding partners meeting in Brussels.