PORTUGUESE PHARMACEUTICAL SOCIETY POLITICAL AND ECONOMICAL FRAMEWORK

Transcription

1 FROM: Portuguese Pharmaceutical Society DATE: TO: European Industrial Pharmacists Group POLITICAL AND ECONOMICAL FRAMEWORK During the year 2013 the economical constraints were the main factor that driven the pharmaceutical market. The year was highlighted by the continuation of public austerity policies and measures with strong impact on the pharmaceutical sector and, therefore, in pharmaceutical practice. 1. EDUCATION AND TRAINING Board of Pharmaceutical Industry Specialists Annual Meeting (RACI) Hands-on Organizing committee: Board of Pharmaceutical Industry of the Portuguese Pharmaceutical Society - Viseu, 24 th to 26 th May th Meeting of Regulatory Affairs Specialists Impacto Regulamentar da Nova Legislação de Farmacovigilância New Pharmacovigilance Legislation: Regulatory Impact - Lisbon, 20 th June 2013 Symposium "O Farmacêutico por outras palavras" The Pharmacist in other words Organizing committee: Portuguese Pharmaceutical Society - Lisbon, 21 th September 2013 These events were part of the celebration of the National Pharmacist s Day, organized annually by the Portuguese Pharmaceutical Society. Fórum Empresarial do Medicamento e Produtos de Saúde Medicines and Health Products Business Forum Organizing committee: Portuguese Pharmaceutical Society and Institute for the Development of Latin America (IPDAL) - Lisbon, 10 th October 2013 This initiative is part of the Portuguese Pharmaceutical Society s purpose to strive for an active role in the economic diplomacy and in the promotion of international competitiveness of the Portuguese health cluster, with a particular focus on the pharmaceutical sector. Ref.: NI/DN/2014/MD/015-1 / 6 - T-NI-01

2 11 th Meeting of Regulatory Affairs Specialists Medicamentos Órfãos: Desafios Regulamentares e do Acesso Orphan Medicinal Products: Regulatory Challenges and Access - Lisbon, 14 th November th Meeting of Regulatory Affairs Specialists Medicamentos Biossimilares Biosimilars Drugs - Lisbon, 13 th February th Meeting of Regulatory Affairs Specialists Perspectiva da nova regulamentação em Ensaios Clínicos: Legislação de alteração da Lei 46/2004 e novo Regulamento Europeu Perspectives on new regulation in Clinical Trials: Amendment to Law 46/2004 and new European Regulation - Lisbon, 27 th March 2014 Educational Plan on Quality matters Organizing committee: National Quality Council of the Portuguese Pharmaceutical Society - Lisbon, January-December 2014 The training plan includes the following sessions: Business Continuity Plan; Risk Management; Change Control; Calibration; Drug Manufacturing Ingredients; Management of Staff Education and Training; Product and Residue Management; Counterfeit control; Stock reintegration; Protocol for medicine spills; Good Community Pharmacy Practices; Good Manufacturing Practices (GMPs); Good Regulatory Practices; Good Distribution Practices; Good Hospital Pharmacy Practices; Good Clinical Analysis Practices. 2. TECHNICAL DOCUMENTS/GUIDES Boas Práticas na Preparação de Citotóxicos Good Practices on the Preparation of Cytotoxics Coordinated by: College of Hospital Pharmacy of the Portuguese Pharmaceutical Society Administração de vacinas e medicamentos injectáveis em farmácia comunitária "Administration of vaccines and injectable drugs in community pharmacy" Coordinated by: Portuguese Pharmaceutical Society Ref.: NI/DN/2014/MD/015-2 / 6 - T-NI-01

3 3. PROTOCOLS AND OTHER RELEVANT INITIATIVES Protocol with the Ministry of Health of Cape Verde In order to support the pharmacists under the supervision of the General Directorate for Pharmacy of the Ministry of Health of Cape Verde, the Portuguese Pharmaceutical Society has signed a cooperation protocol, on May 30 th, in Luanda, Angola, at the X World Congress of Portuguese-Speaking Pharmacists. This protocol will cover the management of internships in Portugal in several areas, namely the Hospital Pharmacy, and will also cover the aid on the definition of new legislation and good practices related to the pharmaceutical sector. Opportunity Exchange Platform The Portuguese Pharmaceutical Society has created a digital platform entitled Bolsa de Oportunidades (opportunity exchange), which is a dynamic virtual space for insertion of the labor opportunities (jobs, internships, scholarships, etc.) by entities interested in recruiting, and for integration of applications submitted by pharmacists. This platform is available in 4. INTERNATIONAL AFFAIRS PHARMACEUTICAL GROUP OF THE EUROPEAN UNION (PGEU) - Brussels, 14 th March 2013 Former PGEU President Filip Babylon appointed to new Pharmacovigilance Committee of the European Medicines Agency Approval of Joint Call for Action on Medicines Shortages (PGEU, EAHP and EIPG) Annual Symposium and - Rome, 16th to 18th June 201 Election of mew PGEU President (Štefan Krchnak, of the Slovak Chamber of Pharmacists) - Brussels, 13 th November 2012 EUROPEAN INDUSTRIAL PHARMACISTS GROUP (EIPG) Symposium "Biotech and Advanced Therapies: Challenges and Opportunities" - Brussels, 19 th April Brussels, 20 th and 21 th April 2013 Election of the new President (Jean Pierre Paccioni - French Order of Pharmacists) and decision of the outgoing president (Luigi Martini) would assume the honorary position of Past President. Ref.: NI/DN/2014/MD/015-3 / 6 - T-NI-01

4 Analysis and discussion of the continuing professional development of Qualified Person and other groups with responsibility in the drug chain, the Directive on falsified medicines, and the problem of medicines shortages at the European level. ASSOCIATION OF PHARMACISTS FROM PORTUGUESE-SPEAKING COUNTRIES (AFPLP) - Luanda, 29 th May 2013 Approval of Resolution on Pharmacy Services, to be made known to the Community of Portuguese-Speaking Countries (CPLP), to the governments and to the general population. Election of the new governing bodies of the Association for the biennium : President (Lucílio Williams, Mozambique), Vice-presidents (João Silveira, President of the of the Portuguese Pharmaceutical Society; Valmir Santi, Vice-president of Federal Pharmacy Council of Brazil). X World Congress of Portuguese-Speaking Pharmacists - Luanda, 30 th May 2013 Plenary sessions dedicated to the production and circuit of medicines, to the regulation of the pharmaceutical sector, to the involvement of pharmacists in health systems, and to the pre and post-graduate training. FARMACIA LATINA Informal Meeting - Paris, 10 th July 2013 Discussion and analysis of issues related to the regulation of the pharmacy profession and activities of community pharmacies in each country represented (France, Italy, Portugal and Spain). Other topics were the new models of remuneration for pharmacies and the economic and financial sustainability problems of these health units. This forum included the intervention of representatives of the General Council of Spanish Pharmacists, the Federation of Pharmaceutical Unions of France, the French Order of Pharmacists, the Italian Pharmacy Owners Federation, the Federation of Italian Orders of Pharmacists, and of the Portuguese Pharmaceutical Society. INTERNATIONAL PHARMACEUTICAL FEDERATION (FIP) 73 th Annual Congress Towards a Future Vision for Complex Patients" - Dublin, 31 th August to 5 th September 2013 Council Meetings - Dublin, 31 th August 2013 Acceptance of the Effective Contribution of Pharmacists in improving maternal, newborn and child health declaration. Election of the Professional Secretary of Board of Pharmaceutical Practice of FIP (Ema Paulino, President of the Lisbon Branch of Portuguese Pharmaceutical Society). Ref.: NI/DN/2014/MD/015-4 / 6 - T-NI-01

5 EUROPHARM FORUM - Dublin, 4th September 2013 Elections to the executive committee. Discussion of priorities and future challenges of this organization. EUROPEAN HEALTH PROFESSIONS COMPETENT AUTHORITIES (EURHECA) Preparatory Meeting of the - Dublin, 6 th September France, 7 th November 2013 Composition of the first Executive Board of EurHeCA, wherein are represented the 5 professions of the Health sector established by Directive 2005/36/EU (directive of Professional Qualifications). Analysis of activities and projects in which the association is involved, such as the adoption of a White Paper about repositories of health professionals data, the collaboration with the South-eastern Europe Health Network (SEEHN), the meeting with the World Health Organization and the European Commission and the impact of a European Professional Card for health professionals. 5. LEGISLATION PUBLISHED Good Distribution Practices (new version) Guideline 2013/C 343/01 The Portuguese version of the Guidelines related to Good Distribution Practice of Medicinal Products for Human Use (2013 / C 343/01) were published in the Official Journal of the European Union on November 23rd, This new version corrects factual errors identified in subchapters 5.5 and 6.3 of the revised Guidelines and details the reasons for its review and sets a new the date of application. This version replaces the previous Guidelines published in March The wholesale distribution of medicines is an important activity in the management of the supply chain. Currently, the network of distribution for medicines is increasingly complex and involves many stakeholders. These Guidelines define appropriate tools to help wholesale distributors to develop their activities and prevent the intrusion of counterfeit medicines in the legal supply chain. The observance of the Guidelines will ensure full control of the supply chain and therefore the maintenance of quality and integrity of medicines. European Directive on the Recognition of Professional Qualifications the Directive 2013/55/EU of the European Parliament and of the Council, was published in the Journal Official of the European Union on December 28th, amending Directive 2005/36/EC related to the recognition of professional qualifications, and Regulation (EU) No 1024/2012 related to the administrative cooperation through the Internal Market Information System (Regulation IMI). Ref.: NI/DN/2014/MD/015-5 / 6 - T-NI-01

6 Law of Medicinal Products for Human Use - Law No. 176/2006 The eighth amendment to the Law of Medicinal Products for Human Use was published, which implemented a measure longed by the Portuguese Pharmaceutical Society - the creation of the subcategory of Non-Prescription Medicines with Exclusive Dispense in Pharmacies. This new category will cover drugs that given its safety profile and their indications may only be dispensed in pharmacies. Included in this sub-category there are medicines corresponding to 17 active principle ingredients on their own and/or in combination. Thus, Portugal joined the group of EU countries that have adopted this same solution, including the UK and the Netherlands. Among the 12 Member-States (out of 28) in which NPM are available outside pharmacies, only Portugal, Italy, Bulgaria and Romania had not yet established this sub-category. Ref.: NI/DN/2014/MD/015-6 / 6 - T-NI-01