This area relates to the activities undertaken by the Agency to support the scientifically sound development of advanced-therapy medicinal products (ATMPs), including gene-therapy, somatic-cell- therapy or human-tissue-engineered products, and other emerging therapies and new technologies that are not within the scope of the Advanced Therapies Regulation. The main tasks of the Committee for Advanced Therapies (CAT), established by the Regulation, are to provide in relation to advanced- therapy medicinal products: draft opinions to the CHMP on the evaluation of marketing-authorisation applications; specific expertise and advice to the EuropeanMedicinesAgency, CHMP and/or the European Commission; input on the certification of quality and non-clinical data; input on scientific recommendations on classification and on CHMP scientific advice. Other emerging therapies and new technologies that are outside the scope of the Regulation are also covered in this strategic area. The year 2010 was the second year of operation of the Agency's Committee for Advanced Therapies (CAT). The Committee deals with advanced-therapy medicinal products (ATMPs) for human use that are based on gene therapy, somatic cell therapy or tissue engineering. These innovative medicines offer groundbreaking new treatment opportunities for diseases and injuries of the human body.
• Networks are very interested in helping PDCO in prioritising therapeutic needs and candidate medicines when several compounds with similar mode of action are being developed for the same condition in a limited patient population. Patients/parents should be involved in priority discussions (and in discussions involving types of paediatric formulation).
Similarly, in March 2011 the U.K. Department of Health released a white paper detailing “what the Gov- ernment will do to support efforts to reduce tobacco use over the next five years...” . This report noted that “the Medicines and Healthcare products regula- tory agency granted an extended indication in 2010 for [pharmaceutical nicotine products] to be used for ‘harm reduction’, to assist smokers who are unwilling or unable to quit, as a safer alternative to smoking and to reduce the health hazards from secondhand smoke. ” In addition, the report stated that the government “ will work in collaboration with the public health commu- nity to consider what more can be done to help tobacco users who cannot quit, or who are unwilling to, to substitute alternative safer sources of nicotine, such as [pharmaceutical nicotine], for tobacco. In sup- port of this, [the National Institute for Health and Clinical Excellence] will produce public health gui- dance on the use of harm reduction approaches to smoking cessation (to be published in spring 2013). We will also encourage the manufacturers of safer sources of nicotine, such as [pharmaceutical nicotine], to develop new types of nicotine products that are more affordable and that have increased acceptability for use in the longer term. ”
detailed and precise account of the work and efforts devoted by the Agency to achieve the goals of the 2003 work programme. The primary objective achieved by the Agency was to guarantee a high level evaluation and control of the safety, quality and efficacy of medicines for human and veterinary use in Europe. It also took up other challenges and in particular prepared for the enlargement of the European Union with the ten new Member States, contributed in an active way to the review of pharmaceutical regulation, continued to further improve its operation and that of its scientific committees, and developed the corresponding information systems. The Agency also reinforced the close links established with the national competent authorities, an essential condition in achieving our mission of public health.
indication for roflumilast is for the “maintenance treatment of chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis in patients at risk of exacerbations” and is more restrictive than broad maintenance treatment of COPD (www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugs AdvisoryCommittee/UCM207377.pdf). In April 2010, the Pulmonary-Allergy Drugs Advisory Committee (PADAC) con- vened by the FDA voted by 10 votes to five against approving roflumilast for the treatment of COPD (www.medscape.com/ viewarticle/720010). Although the PADAC believe roflumi- last to be safe and modestly effective, it seems likely that this negative outcome reflects a concern that the potential adverse events outweigh the modest improvements in lung function. However, on 22 April 2010, the EuropeanMedicinesAgency Committee for Medicinal Products for Human Use adopted an opposite stance to PADAC and recommended the granting of a marketing authorization for roflumilast. The approved indication is for the “… maintenance treatment of severe chronic obstruc- tive pulmonary disease (COPD, FEV 1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment” (www.ema.europa.eu/pdfs/human/ opinion/Daxas_15986110en.pdf). A final decision by the FDA is expected in May 2010 after negotiations with Forest. Regard- less of the outcome of those talks, in the European Union at least, after more than 20 years of development, roflumilast will become the first class PDE4 inhibitor for the treatment of COPD and will provide physicians with another treatment option for patients with more severe disease.
During 2009, the European Commission drew up preparatory documents in the core MDG areas of human development like health, education and gender equality. The adoption of these policies in 2010 will shape the internal EU debate on MDGs and feed into the EU contribution to the UN's MDG Review Summit in September 2010. The Commission's concern is for the EU to agree a comprehensive approach on how to accelerate progress towards attaining the MDGs by 2015 and how to consolidate the gains so as to make them sustainable. Several initiatives, including a Communication on tax governance in developing countries and a review of thematic policies in the field food security were also included.
In terms of improving the information available on centrally authorised medicines, the Agency has progressed its collaboration with the European Network for Health Technology Assessment (EUnetHTA), a body representing the HTA bodies from across Europe. Following the gathering of requirements from HTAs on how information on the benefits and risks of a medicine should be included in the EPAR to make a better contribution to relative-effectiveness assessments by HTA bodies, the Agency revised its EPAR template, which was in use all through the year. The Agency and EUnetHTA are currently reviewing their experience with the new template with a view to further refining requirements and fine- tuning the template as necessary.
In the energy sector, most of the supply contracts have been successfully finalised. The electrometers and the related automated reading system, the reactive power compensation equipment, the meter calibration laboratory, the pollution control and weather/wind monitoring system, the Supervisory Control and Data Acquisition (SCADA) system and the customer care system for the electricity utility have been delivered and installed in 2010. In some cases beneficiary’s action (to secure a better location, to connect to power supply, to employ additional staff) is necessary for an effective use of the investments. The works on the Solar Power Plant have started. On other contracts progress was limited. Under the interconnection metering contract the preparation of the installation sites by the beneficiary is still pending. The technical assistance for the restructuring of the electricity utility, despite adapting its objectives to the needs of the beneficiary, lacked the full cooperation of the counterparts to enable timely and effective completion.
The majority of positive CHMP opinions adopted in 2008 related to cancer medicines, followed by anti- infectives and medicines for the treatment of neurological and central-nervous-system conditions. One further positive opinion was adopted in favour of granting a conditional marketing authorisation (a one-year authorisation, renewable annually, on condition that certain specific obligations are met), while negative opinions were adopted for 7 applications. Twenty-three applications were withdrawn by applicants before completion of the evaluation procedure.
The public-health issue to which the Agency devoted most attention in 2009 was the outbreak and rapid global spread of the H1N1 influenza ('swine flu') virus. The fast-track review of pandemic vaccines – and the close monitoring of these vaccines once they were being used to vaccinate millions of European citizens – demonstrated to Europe and to the world that the Europeanmedicines network can deliver high-quality scientific assessments even under enormous pressure.
The AAR contains a detailed record and description of the outputs achieved in 2010 together with specific tables outlining areas of expenditure by theme, region and country. The number and type of outputs measure the use of resources given to the agency to achieve the annual objectives (internal efficiency) and the added value. Outputs refer to the countries, functions and themes defining the field of activity (external efficiency). They do not indicate the quality of an activity or its impact as this is ensured through the performance-based approach. In 2010 the ETF corporate performance indicators were revised to cover both qualitative and quantitative aspects. The activity-based budget tables in particular demonstrate the use of resources according to the three dimensions of ETF planning policy (geographical, functional and thematic). The report incorporates details of the specific requests received from the European Commission and the services provided by the ETF in response. The 155 corporate outputs achieved are slightly lower than the 158 targeted (the remainder will be completed at the beginning of 2011), but they are in line with the final budget received by the ETF and indicate the level of achievement of the objectives proposed in the Work Programme. The AAR shows a significant increase in policy analysis outputs (29 against the 17 planned), those related to support to the European Commission (30 against 24 planned) and dissemination and networking (30 to 27 planned). This came at the expense of capacity building outputs (66 to 94 targeted). This is explained by the increased importance of evidence-based policy making activities (requiring policy analyses) and the requests from the European Commission (which slightly increased in 2010 and were more diverse, according to the DGs requesting ETF work). Although the outputs from the Torino Process have been counted as policy analysis, the report also explains that the process has a two-fold objective: as an objective of the process is increasing capacity for evidence-based policy making, the activities could also be considered as capacity building outputs.
Some 37 unaccompanied minors applied for asylum in Ireland during 2010. On a national level, activities outlined under commitments in the 2009 Joint Protocol on Missing Children and the Implementation Plan from the Report of the Commission to Inquire into Child Abuse, 2009 continued. The ‘equity of care’ policy contained within the Implementation Plan sought to end the use of separate hostels for unaccompanied minors and to accommodate them on a similar level with other children in care by December 2010. During 2010 a national policy regarding unaccompanied minors came into operation in which minors over 12 years are assessed for a maximum of six weeks at a centre in Dublin before dispersal to a foster placement. From January 2010, all newly arriving children under 12 years were placed on arrival in a foster care placement. All newly arrived minors over 12 years were placed in one of the four registered residential intake units for four to six weeks, where a preliminary assessment of the minor and their needs is carried out by a social worker in conjunction with qualified residential social care staff, with input from a psychologist if required. All unaccompanied minors are allocated a social worker on arrival, with an initial care plan developed in conjunction with social/care staff. By the end of 2010 (1 December), 35 unaccompanied children were living in foster placements, 24 in children’s homes, 15 in hostels and 20 in supported lodgings. 27 In figures released in January 2011, the Health Service Executive (HSE) stated that 11 unaccompanied minors went missing from State care during 2010. Of this number, six minors are still missing. The missing minors were from a diverse range of countries including Nigeria, Somalia, Afghanistan and the Democratic Republic of Congo. The report noted that of a total of 512 minors who had gone missing from care between 2000 and 2010, some 72 have been found by authorities.
The EEAC annual conference was held in Bruges, Belgium in October 2010 and participating councils adopted a statement on Sustainable Land-Use. In its statement, the EEAC called on the European Commission to support an EU scheme aimed at having a coherent network for connecting and strengthening landscapes and recommended that the concept of ‘sustainable land use’ should form one of the main topics to be taken forward within the context of the EU Sustainable Development Strategy. Noel Casserly, Director of Comhar SDC made a presentation on its work on Green Infrastructure for Ireland - Enhancing Natural Capital for Human Wellbeing. Niamh Kirwan also attended the conference.
The quality of this report is improving year on year, as more detailed and reliable data are being provided by the Member States. Despite the fact that economic fleet data normally has a two year time lag compared to today, the economic experts involved are also delivering useful insight to today's realities in the sector. I nevertheless deeply regret that some Member States are still failing to comply with DCF obligations, either by not submitting complete data on time or by not submitting data at all. In particular, as presented in this report, Greece and Spain did not deliver any 2008 economic data at all. Belgium, Bulgaria, Denmark, Greece, Ireland, Latvia, Portugal, Romania, Slovenia and Spain delivered data with one or more missing groups of variables in 2002-2008.
Since becoming a full member of intoSAi in 2004, the court has actively participated in the subcommit tees on auditing. the cour t also provided input to the subcommit tees o n p ro m otin g b e s t p r a c ti ce s an d qu a li t y assurance through voluntar y peer reviews, a n d h a s p r o m o t e d i n c r e a s e d c a p a c i t y - building activities among intoSAi members. Since 2008 the court has chaired the working group on accountabilit y for, and audit of, d i s a s t e r- r e l a t e d a i d. A m a i n a i m o f t h i s working group is to develop guidance and to identif y and disseminate good practices in the area of account abilit y for dis as ter- r e l a t e d a i d , c o n c e n t r a t i n g o n a c t i v i t i e s d i r e c t e d t o s t a k e h o l d e r s (m u l t i l a t e r a l s , a i d o r g a n i s a t i o n s , g o v e r n m e n t s , p r i v a t e auditors). the interim report of the working g r o u p w a s s u b m i t t e d t o t h e i n t o S A i congress in november 2010.
Further to its 2009 advice to the European Commission on the review of the FICOD on definitions, scope and internal control requirements, and how these areas and their implementation within the existing legislative framework may impact on the fulfilment of the objectives of the FICOD, supervisors felt it was necessary to immediately start working on one topic, namely participations, so as to strive for more convergence between Member States, even before the review of the FICOD. Accordingly, the JCFC established a Participations Working Group to concentrate on identification of financial conglomerates and specifically to address how to include participations in the calculation (durable link, indirect participations) and, once identified, how to include participations in day-to-day supervision (for example risk concentration and intra-group transactions and what kind of information could reasonably be obtained in the case of non-controlled participations). By the end of 2010, the JCFC’s Participations Working Group had prepared draft guidance on the concept of a durable link in respect of how to include participations in the calculations when identifying a financial conglomerate.
The constant monitoring of the safety of medicines after authorisation (‘pharmacovigilance’) is an important part of the work of the national competent authorities and the EuropeanMedicinesAgency. The Agency receives safety reports and product quality defect reports from within the EU and outside concerning centrally authorised medicinal products and coordinates action relating to the safety and quality of medicinal products.
Main challenges for the management during the recent period have been: (i) establishment of a proper working environment for the Institute, which consisted of consolidating the human resources into a functioning team, developing ownership of the annual and mid-term work programmes among staff , developing function- ing work structures and fi ne-tuning the tasks and job description of each individual member; (ii) developing a functioning administrative structure, which included the setting up inter- nal rules (mission, training, traineeship policies, initial information on internal control standards and risk manage- ment, fi ling and archiving system, etc.); (iii) developing fi nancial and accounting procedures (fi nancial cir- cuits, payment and commitment pro- cedures, etc.); (iv) human resources management (development of the necessary implementing provisions giving eff ect to the Staff Regulations, a multiannual staff policy plan, planning and implementing the recruitment of new staff , a policy on language and other training, etc.).
The Agency issues plasma master file (PMF) and vaccine antigen master file (VAMF) certificates of a medicinal product in conformity with the arrangements laid down by Community legislation. The Agency PMF/VAMF certification process is an assessment of the PMF/VAMF application dossier. The certificate of compliance is valid throughout the European Community.