About WPE

About WPE http://www.ifapp.org/home/ethics/about-wpe/about-wpe 1 Ethics in Pharmaceutical Medicine http://www.ifapp.org/home/ethics/about-wpe/about-wpe/1-ethics-in-pharmaceutical-medicine Ethics in medicine and particularly pharmaceutical medicine are being questioned and challenged almost daily. The revised Declaration of Helsinki, the EU Clinical Trial Directive, the book by Sonia Shah ‘The Body Hunters: Testing New Drugs on the World's Poorest Patients’ from 2006 and John le Carré’s ‘The Constant Gardener’ the inevitably open our industry to ever-increasing public scrutiny. Dialogue amongst patients, investigators, institutions, sponsors and the media highlights the need for transparency, and guidance on how to manage these situations responsibly, before they become issues. We find ourselves faced with numerous challenges in the varied ethical and cultural issues in Pharmaceutical Medicine across the globe, and in the ethical dilemmas across the therapeutic spectrum. Interestingly the literature and most of the reference books authored by respected academics are collections, collations and commentaries from a number of sources and fail to provide guidelines. http://www.ifapp.org/home/ethics/about-wpe/about-wpe/1-ethics-in-pharmaceutical-medicine Wed, 11 Apr 2007 04:48:14 -0500 2 Code of conduct http://www.ifapp.org/home/ethics/about-wpe/about-wpe/2-code-of-conduct Ethical considerations have always been central to the role of the pharmaceutical physician as the guardian of patient safety both in clinical trials and in future usage of the medicine so developed. However, these issues have always been addressed from a clinician’s perspective, and not from a Pharmaceutical Industry position. As the pharmaceutical market is a global rather than a domestic one, IFAPP opened the debate for multinational discussion. We wanted to establish ‘IFAPP positions’ on ethical issues in pharmaceutical medicine. It was appreciated that it would not be possible to originate the definitive guideline or position, but we felt that we could create a code that could at least focus further and wider discussion. http://www.ifapp.org/home/ethics/about-wpe/about-wpe/2-code-of-conduct Wed, 11 Apr 2007 04:48:32 -0500 3 Declaration of Helsinki http://www.ifapp.org/home/ethics/about-wpe/about-wpe/3-declaration-of-helsinki The single most important precipitant of the spotlight that is now focused on the Pharmaceutical Industry was the 2000 reworking of the Declaration of Helsinki, followed almost immediately by a series of articles in the Washington Post. The World Medical Association [WMA] seemed to be surprised at the level of opposition the revised Declaration received. It must be remembered that the organisational structure of the WMA is based on representatives from the associations of doctors from approximately 70 member countries. Concern had been expressed that problems of research in the Developing World may have been inadequately addressed by the 1996 version of the Declaration, and that it needed further attention. The approach was perhaps humanitarian/ethical rather than procedural, without realising that some very basic industry research requirements and topics were being overlooked. A draft of the proposed ‘new’ Declaration of Helsinki was published on the Internet prior to the meeting in Edinburgh at which it was adopted, but few commented. To a certain extent the focus of much of the pharmaceutical industry was on other issues such as intellectual property and patent rights/compulsory licensing - the ‘hot topics’ during the latter half of 2000. However, on 7th October 2000 the 44 countries represented at the Edinburgh meeting (approximately 60% of all member countries) unanimously adopted the new Helsinki. Relatively shortly after this (in 2002 and 2004) clarification of two clauses was published by the WMA, but many pharmaceutical companies and some entire countries never adopted the 2000 version, preferring instead to continue to follow the 1996 version. In 2008 a new version was published in Seoul, Korea (WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, 59th WMA General Assembly, Seoul, October 2008). http://www.ifapp.org/home/ethics/about-wpe/about-wpe/3-declaration-of-helsinki Wed, 11 Apr 2007 04:49:09 -0500 4 Declaration of Helsinki - aspects of law http://www.ifapp.org/home/ethics/about-wpe/about-wpe/4-declaration-of-helsinki---aspects-of-law The Declaration of Helsinki was always intended to be a guideline, but although it is not supposed to be legally prescriptive some articles (Article 9 for example) have the flavour of a legal document. Authorities in various countries have incorporated it into the laws of their country, so sections of Helsinki have in fact become law. For instance, in the USA some of it was incorporated into the Code of Federal Regulations such as CFR21 312.120 and it is also referenced in ICH GCP (E6) and other major guidelines. But there is confusion over the use of the Declaration: different laws refer to different versions of Helsinki, most companies refer to the 1996 version, but some ethics committees want to have reference to the 2000 version. http://www.ifapp.org/home/ethics/about-wpe/about-wpe/4-declaration-of-helsinki---aspects-of-law Tue, 28 Apr 2009 08:33:30 -0500 5 The European Clinical Trials Directive 2001/20/EC http://www.ifapp.org/home/ethics/about-wpe/about-wpe/5-the-european-clinical-trials-directive-2001/20/ec The European Directive was perhaps the single most important issue for the industry in recent years. The EU has laid down guidelines for clinical trials, which include ethics, and these guidelines became law for the European Member States. The implication is that as a significant percentage of clinical trials are done in Europe this will actually become an international guideline. But the Directive differs in several areas from the Declaration of Helsinki and from the ICH guidelines – on the issue of obtaining informed consent for example – and it has become clear in the six years since it became law in the EU that some parts of it will require revision, and this is ongoing. http://www.ifapp.org/home/ethics/about-wpe/about-wpe/5-the-european-clinical-trials-directive-2001/20/ec Wed, 11 Apr 2007 04:50:01 -0500 6 Paediatric rules and regulations http://www.ifapp.org/home/ethics/about-wpe/about-wpe/6-paediatric-rules-and-regulations To address the need for responsible research into the effects of drugs in children, in the US the Food and Drug Administration Modernization Act (FDAMA) in 1997 enabled the FDA to request labelling information for new drugs that would be commonly used in children. It also allowed them to request paediatric testing of drugs already on the market where lack of data could pose risks. The Final Rule to this legislation in 1998 (effective December 2000) made such testing mandatory where a drug or biological agent offered a ‘meaningful therapeutic benefit’ or there would be more than 50,000 patients for the labelled indication in children and the absence of labelling might pose a risk. It allowed the FDA to demand studies; if data were not provided, the drug would not be licensed for use in children.  The inducement offered by the US government was that if FDAMA was followed, companies would have six month’s exclusivity on their marketing licence, and a six-month patent extension – even if the paediatric data were insufficient to obtain a paediatric licence. The FDA concluded in 2002 that FDAMA had been a success; “many drugs have been studied in children … [and] … it has become more routine for companies to evaluate and plan appropriately for studying the new product in children”.  FDAMA was originally planned to have a “sunset date” of 1st January 2002, but this was extended to October 2007 by the Best Pharmaceuticals for Children Act 2002 (BPCA). This act enabled the FDA to insist on label changes, and to set up an Office of Pediatric Therapeutics to coordinate all their activities in this field.  The Pediatric Research Equity Act (PREA) in 2003 further strengthened the regulatory requirements for paediatric studies, following a court case in which it was successfully argued that the FDA had exceeded its authority under both FDAMA and BPCA. All three acts have had a beneficial effect in stimulating sound research into the use of drugs in children. As of May 2010, over 367 products had new and specific child-related labels, mostly new dosing recommendations and new safety information. Between September 2007 and the end of 2009 there were 224 paediatric studies performed under PREA and BPCA. (<a href="http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/PediatricTherapeuticsResearch/UCM163159.pdf">http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/PediatricTherapeuticsResearch/UCM163159.pdf</a> accessed 8th June 2010)In the European Union similar legislation was developed. A Regulation (726/2004) became law in all Member States in June 2007. It was designed to increase the development of medicines for use in children using high quality research, and to improve the information available on the use of medicines in children. The Regulation also mandates that all such studies must be done under the requirements of the EU Clinical Trials Directive 2001/20/EC. http://www.ifapp.org/home/ethics/about-wpe/about-wpe/6-paediatric-rules-and-regulations Mon, 07 Mar 2011 07:28:55 -0600 7 Conclusions http://www.ifapp.org/home/ethics/about-wpe/about-wpe/7-conclusions To conclude, ethics in pharmaceutical medicine is a vast subject. We hope that by working on this Code we may have begun the process of helping the transparent discussion of the issues it raises. We have no absolute answers but hope that the points we raise in the Code will stimulate others to consider in thoughtful depth the points raised. http://www.ifapp.org/home/ethics/about-wpe/about-wpe/7-conclusions Wed, 11 Apr 2007 04:50:18 -0500 8 PMEC members http://www.ifapp.org/home/ethics/about-wpe/about-wpe/8-pmec-members The Chairman of the Working Party was Dr Sander Becker of Australia. Other participants were Drs Jane Barrett (UK), Johan De Botha (S Africa), Johan Brun (Sweden), David Cairds (Germany), Roberto Carlesi (Italy), Luis Collia (Argentina), Maqbool Jafary (Pakistan), Gerhard Nahler (Austria), Antti Jekunen (Finland), Francis Halleux (Belgium), Ludger Buehrmann (Germany), and Alan Duton (USA). http://www.ifapp.org/home/ethics/about-wpe/about-wpe/8-pmec-members Tue, 28 Apr 2009 08:31:12 -0500 9 PMEC Constitution http://www.ifapp.org/home/ethics/about-wpe/about-wpe/9-pmec-constitution Pharmaceutical Medicine Ethics Council [PMEC] Founded 1st March 2008  Executive Summary Medical ethics has been governing human behaviour as far back as 460-357 BC. As science becomes more innovative and medical research processes more creative, the ethical boundaries that limited “what was considered possible” are now being challenged by scientific endeavour using rational justifications that often go beyond common sense. Controversial “ethical” issues emanating from the revised Declaration of Helsinki, the EU Clinical Trials Directive as well as the Media – the Washington Post "Body-hunters" series, "60 minutes” and “Larry King”, etc. inevitably open the pharmaceutical industry to ever increasing public scrutiny.   Since Thalidomide in the 1960’s which forced the International Pharmaceutical Industry and the world authorities to question their thinking and the recent Vioxx voluntary withdrawal with the ensuing Cox 2 fallout  [2004] has further tested Pharmaceutical Physicians’ resolve.  The Northwick Park Monoclonal antibody Phase 1 disaster in TeGenero 2006 further drives health agency a rethink and community insecurity surrounding safety issues, leading to legal challenges.   There is a need for truth, transparency and trust on how Pharmaceutical Physicians as "the conscience and guardians” of Pharmaceutical Ethics can pro-actively and responsibly manage these situations, well before they become major issues or legal landmarks and precedents. Pharmaceutical Physicians and Health Professionals should recognise their ethical responsibility and stand aside from company or product loyalty when assessing factors affecting their products. They must remain aware at all times that the ultimate interests of both patients and their own employers are best served by an objective scientific attitude. The IFAPP recognises that this may place practising Pharmaceutical Physicians and Health Professionals in a position that demands considerable determination. IFAPP has recognised that there are ethical issues that are of particular relevance to Pharmaceutical Physicians.  IFAPP believes that it has a responsibility to define and publish standards to which Pharmaceutical Physicians and health professionals can refer and may be measured against when dealing with ethical issues in the field of Pharmaceutical Medicine. Content   <ul><li>Foundation and History </li><li>Role of the Pharmaceutical Medicine Ethics Council [PMEC]</li><li>Membership of Pharmaceutical Medicine Ethics Council </li><li>Membership and Due Process  </li><li>Finances </li><li>Additional information </li><li>Contact Address for IFAPP Pharmaceutical Medicine Ethics Council </li><li>IFAPP Code 2002 </li><li>Agendas and Minutes</li><li>Publications, Posters, Reports and Articles.</li></ul>Foundation and History The IFAPP has more than a 30-year history in Pharmaceutical Medicine Development and Therapeutics since the foundation of the Federation in 1975. Invitation to form an IFAPP Working Party (WP) on Ethics in Pharmaceutical Medicine was sent to the National Presidents on 6 June 2001. IFAPP’s Code of Ethical Conduct Working Party was established under the IFAPP in 2002. The Founding Members were Dr Jane Barrett [UK] Co–Chairperson, Dr Sander Becker [Australia] Co-Chairperson, Dr Johan Brun [Sweden], Dr Ludger Buehrmann [Germany], Dr Anthony Chan [Ireland], Dr Luis Francisco Collia [Argentina], Dr Johan De Botha [South Africa – passed away 2003] , Dr Alan Dunton [USA], Dr Francis de Halleux [Belgium], Dr Maqbool H. Jafary [Pakistan], Dr Antti Jekunen [Finland] and Dr Gerhard Nahler [Austria]. International Code of Ethical Conduct was presented at a symposium at ICPM2002 in Cancun [2002] and a lecture at ICPM2004, Geneva [2004]. IFAPP Codes were published in 2003 in the International Journal of Pharmaceutical Medicine. With the commencement of Pharmaceutical Medicine Ethics Council [PMEC], a new framework started on 1st March 2008 that replaces the previous Ethical Conduct Working Party, the WPE. Role of Pharmaceutical Medicine Ethics Council PMEC members are appointed by the IFAPP Officers, Executive Committee and / or the IFAPP House of Delegates to provide independent medical scientific ethical advice on Pharmaceutical Therapeutics Development to the IFAPP Executive Committee [IFAPP] on the safety, quality and performance of Pharmaceutical development of drugs and devices, including issues relating to manufacture, preclinical and clinical research, pre-market conformity assessment and post marketing monitoring. Chairperson is an ex officio member of the IFAPP Executive Committee. Pharmaceutical Medicine Ethics Council is to be updated two-yearly at the face-to-face meeting and / or the House of Delegates meeting. This is to ensure that IFAPP remains globally relevant to the IFAPP’s contemporary global cultural setting. Membership of the PMEC and Due Process Members: PMEC is made up of 5 Core Members and up to 20 associate members [if needed]. Expertise: Together members have expertise in a broad range of disciplines including Pharmaceutical Medicine, Physicians as Investigators, General Medical Practice, Over-the-Counter Medicine, Cosmetics, Nutrition and Nutraceuticals, Herbal Medicines, Surgery, Paediatrics, Geriatrics, Women’s Health, Preventive Medicines, Restorative Medicine, Biomedical Engineering, Diagnostics, Devices, Manufacture and consumer issues etc. The IFAPP prescribes that the membership of the PMEC consists of at least 5 core, and not more than 20 associate members [if needed]. Core Members of at least 5: <ul><li>3 persons, each of whom is a Pharmaceutical Physician eminent in their profession. </li><li>All remaining core members and associate members to have specialist qualifications and experience in disciplines complementary to that of the core membership. </li><li>The remaining core members and associate members may be invited depending on the ethical issue or ethical dilemma which requires IFAPP expertise and opinion. They may include, but are not limited to persons meeting the descriptions below:-</li></ul>·         physician with expertise in consumer issues; ·         physician with expertise in pharmaceutical industry issues; ·         person who is a biomedical engineer, or who holds a university degree in biomedical engineering or in biomaterial science; ·         person with expertise in regulatory affairs or who holds a university degree in Pharmacology; ·          person with expertise in Manufacturing Pharmacy or who holds a university degree in Pharmaceutical Chemistry. ·         medical practitioner involved in clinical research; ·         physician with specialist skills in clinical medicine and eminent in the medical profession.   Due Process All requests of ethical deliberation to the PMEC are to be sent in writing to the Chairperson, Core Members or via the IFAPP Secretariat or IFAPP Executive Committee. PMEC meetings to have agenda and minutes recorded. Bi-annual PMEC teleconferences to be held at least one month prior to the IFAPP face-to-face meetings and House of Delegates meeting to maintain and update the PMEC Core Members. Similarly associated members are expected to attend teleconferences according to the agenda. Decision Mechanism of Pharmaceutical Medicine Ethics Council Model [in progress]. <table border="1" cellspacing="0" cellpadding="0" class="MsoTableGrid"><tr><td width="36" valign="top"> </td><td width="116" valign="top">Core Members</td><td width="90" valign="top"> </td><td width="114" valign="top">Qualifications - degrees</td><td width="84" valign="top">Country</td><td width="129" valign="top">Specialty / Expertise / Experience</td></tr><tr><td width="36" valign="top">1</td><td width="116" valign="top">Chairperson</td><td width="90" valign="top">Dr Jane Barrett</td><td width="114" valign="top">MB BS, FFPM, LLM</td><td width="84" valign="top">UK</td><td width="129" valign="top">Pharmaceutical Physician  and Medical Law</td></tr><tr><td width="36" valign="top">2</td><td width="116" valign="top">Co - Chairperson [interim]*</td><td width="90" valign="top">Dr Sander Becker</td><td width="114" valign="top">MB.BCh, FFPM, Dip. Bus Admin</td><td width="84" valign="top">Australia</td><td width="129" valign="top">Pharmaceutical Physician, Ethics and Drug Development</td></tr><tr><td width="36" valign="top">3</td><td width="116" valign="top">Secretary</td><td width="90" valign="top">To be nominated</td><td width="114" valign="top"> </td><td width="84" valign="top"> </td><td width="129" valign="top"> </td></tr><tr><td width="36" valign="top">4</td><td width="116" valign="top"> </td><td width="90" valign="top">To be nominated</td><td width="114" valign="top"> </td><td width="84" valign="top"> </td><td width="129" valign="top"> </td></tr><tr><td width="36" valign="top">5</td><td width="116" valign="top"> </td><td width="90" valign="top">To be nominated</td><td width="114" valign="top"> </td><td width="84" valign="top"> </td><td width="129" valign="top"> </td></tr><tr><td colspan="6" width="568" valign="top">* Until next House of Delegates meeting</td></tr></table>Finances and Budget The Chairperson and Core Members will prepare a Profit and Loss (P&L) statement for the financial year and a budget for the coming year. The PMEC is entitled to set up working groups and/or task forces composed of Core Members [and associate members if needed] to focus on a specific objective and/or to achieve specific tasks. The agreed P&L and budget will be submitted by the Chairperson to the IFAPP President and Treasurer for approval. The budget should provide sufficient financial resources to allow the PMEC to fulfill its objectives, but remain within the limits imposed by IFAPP’s Executive Committee. Unbudgeted expenses and new projects emerging during the current year should be discussed with the President and Treasurer of IFAPP and should neither be committed nor initiated before their approval Additional Information For further information please contact the IFAPP Secretariat. Contact Address for IFAPP Pharmaceutical Medicine Ethics Council [PMEC]  IFAPP secretariat Mrs Caroline van Bruggen Kuipersweg 2T 3449 JA Woerden  The Netherlands phone: +31 (0)348 489 305 fax: +31 (0)348 489 301  e-mail: <a href="mailto:ifapp@planet.nl">ifapp@planet.nl</a> web site: <a href="/" target="_blank">www.ifapp.org</a>  IFAPP Codes   IFAPP Codes 2002 <ul><li>Published in 2003 in the International Journal of Pharmaceutical Medicine.</li><li>[To be updated to become a living document and more relevant to a contemporary a global cultural setting by December 2008]. </li></ul>Publications, Posters, Reports and Articles   ·         Report: International Code IFAPP Working Party Report: Background and process establishing the Working Party and Code (IFAPP News 293 Page 6, International Journal of Pharmaceutical Medicine 2001, 8:291–306). ·         Publication: Ethics in Pharmaceutical Medicine of Ethical Conducted published in 2003(<a href="/">www.IFAPP.org</a> – Ethics – Code – Addendum) ·         Poster - International Code of Ethical Conducted presented at the ICPM2002 in Cancun [2002] and Geneva [2004]. ·         Article: Ethics in pharmaceutical medicine -The Ethical Issues Working Group of the Faculty of Pharmaceutical Medicine has published an important article in the International Journal of Pharmaceutical Medicine (1998;12:193-198). ·         Publication: IFAPP World I December 2006 Page 8 – “High and communication” – “section e. “ethical code of conduct” ·         Publication: IFAPP World II July 2006 Page 11 – “High Importance of IFAPP’s Code of Ethics Conduct”. ·         Presentation:  IFAPP Executive Committee Face-to-face meeting Vienna Exercise in ethical decision making using a variety of decision making or ethical models - March 24 2007. ·         Publication: IFAPP World III December 2008 Page 6 – “Short Tutorial in Ethical Conduct Decision-Making”.  http://www.ifapp.org/home/ethics/about-wpe/about-wpe/9-pmec-constitution Wed, 10 Mar 2010 07:46:00 -0600