here - Faculty of Pharmaceutical Medicine
Transcription
here - Faculty of Pharmaceutical Medicine
FPM e-newsletter No. 46 – Autumn 2015 International perspectives on Pharmaceutical Medicine Contents Page 2 Editorial Asad Khan Introduction Ibrahim Farr Page 5 Global Clinical Trials: A Bridge Too Far Keith Bragman, Ben Cottam Page 9 Pharmaceutical Medicine and Market Access in a Free Market Economy: One of Many Opportunities for the Faculty of Pharmaceutical Medicine in North America? Peter Gardiner, Declan O’Callaghan Page 12 A tribute to Dr Jack Watters Keith Bragman Page 13 Pharmaceutical Medicine in Africa Bernd Rosenkranz, Michael Reid, Elizabeth Allen Page 17 Pharmaceutical Medicine in the Asia-Pacific region Victoria Elegant, Pippa Biswas, Ritu Sahni Page 20 Advancing Education and Training in Pharmaceutical Medicine in Europe Dominique Dubois, Jens Wurthner, Piotr Krzeski, Fergal Donnelly Editorial Dr Asad Khan MFPM Editor Hello and welcome to the autumn edition of your newsletter! This edition focuses on the practice of pharmaceutical medicine outside the UK, our international members spread all over the world and the wonderful work that is being done by our international committee and all the members. I am sure after reading all the brilliant articles you will realise that from our humble beginnings 25 years ago, our specialty has come a long way! The diversity of the markets, countries, regulations and therapeutic areas in which we operate is staggering. A single multi-centric international clinical trial, pharmacovigilance or medical affairs function may face very different challenges in different parts of the world and it is this diversity and variety that makes many of us tick and makes our specialty so exciting and stimulating. Pharmaceutical industries in more and more countries are now beginning to realise the value, importance and significance of pharmaceutical physicians and I am sure that in the next 25 years our specialty will be duly recognised in all the major markets of the world! Finally, I would sincerely like to thank our international committee members who have contributed some very insightful and informative articles. Remember all your suggestions for improvement are warmly welcome. Please contact me or Ben Cottam in the Faculty office ([email protected]) with your ideas. Happy reading! Introduction Dr Ibrahim Farr FFPM (Spain) Chairman, International Committee The International Committee (IC) is one of the operational committees of the Faculty of Pharmaceutical Medicine (FPM). The committee has been in existence almost since the inception of the FPM and has become increasingly active in the FPM strategic and tactical planning, in order to better serve the sizeable (24%) international FPM membership, promote Pharmaceutical Medicine (PM) globally and make the FPM a reference educational and standard-setting body beyond the UK. Figure 1: FPM membership – proportion by geographical location – September 2015 2 The main objective of the IC is to support the FPM in its mission "… to advance the science and practice of pharmaceutical medicine for the benefit of the public". Hence, the IC encourages input to FPM activities from non-UK based members; helps in promoting the FPM and PM to relevant international bodies; supports the development of the specialty internationally, including the Diploma in Pharmaceutical Medicine exam (DPM); harmonises professional and ethical standards globally and represents as wide a membership as possible. Actually, over the last six years, the IC has evolved from a Europe-centric Committee to a truly global one with a larger number of members who have represented or are representing several countries and regions globally: Australia, Belgium, China, France, Germany, India, Ireland, Italy, Japan, Poland, Singapore, South Africa, Spain, Switzerland, USA and... counting! Despite the wider spread of the membership of the IC, we have been able to keep attendance to our four to five meetings held each year pretty crowded and well above a 75% attendance rate, call on call. Moreover, we have stimulated the members of the IC to connect with those FPM members who reside in their respective countries and bring them into the loop. To start with, we have networked successfully in North America and Switzerland to engage the local FPM membership (and pharmaceutical physicians who are not yet members) and cement a solid partnership for the future, keep a vital link for them with the FPM and prepare the ground to establish an environment supportive to upgrade PM as a medical specialty in those regions. The IC has also led efforts over the last few years to establish ex-UK venues for the DPM, with the objective of bringing the exam closer to the place of residence of many potential future members. The experience has been mixed but we hope to continue to explore the possibilities in the future. We will also support the development of events and activities held outside the UK. Finally, we’ve drafted the IC slides in the FPM slides deck prioritising the activities of the IC and providing the international members with a tool to promote the FPM widely in their countries and beyond. When we were invited to collaborate in this special FPM e-Newsletter to present and reflect on PM and its international footing, we thought that this is very timely since the second 3-year tenure of most of the current members of the IC will come to an end by November 2015. The following sections, which have had contributions by almost all of the IC members, will reflect on PM development in North-America, Africa, Asia-Pacific and Europe. These individual sections are introduced by an article comparing and contrasting the different regulatory environments for the publication of clinical trial data across the major regions of the world. We hope that this overview of the development of our specialty in these regions will lay the ground for the new generation of pharmaceutical physicians to continue the progress of our specialty beyond what is now in many of these countries and regions. We hope you will enjoy this journey throughout our global footing..! 3 4 Global Clinical Trials: A Bridge Too Far Dr Keith Bragman MD(Lond) FRCP(Lond) FRCP(Edin) FRCPath PFPM President, Faculty of Pharmaceutical Medicine Dr Ben Cottam PhD Policy and Communications Officer, Faculty of Pharmaceutical Medicine Introduction This edition of the newsletter examines the practice of pharmaceutical medicine around the world. Despite the progress in promoting the needs of the patient and society in medicines development, we still do not have a uniform global playing field. This is despite the degree of joined-up thinking throughout the world. Many clinicians, regulators, legislators and the pharmaceutical industry now see the value of clinical trial registration and results disclosure. Data dissemination and participant anonymity in clinical trials is currently being debated in the USA and Europe. The European Medicines Agency (EMA) has recently published proposed requirements. However the uniform translation of principles into national legislation and then into a regulatory framework remains elusive. In this article we compare and contrast the ethical guidelines and regulatory requirements in some of the major regions of the world. Ethical Guidelines The current international ethical guidelines are alike in tone and emphasis, though they are not particularly precise or prescriptive. Let’s begin with the Declaration of Helsinki (October 2013): 35. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. 36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication. Good Pharmaceutical Medical Practice (FPM, 2014) Clause 71: The Faculty advocates the following principles [...]: Timely registration of all clinical trials Prompt communication of overall clinical trial results to all participants Authors of documents that are released into the public domain must be fully conversant with the study results and supporting data Summary results must be made public as soon as possible after completion of a clinical trial The date of release of information should not be dependent upon market or pricing approval or the continuation or discontinuation of the clinical trial or the whole project Release of anonymised patient-level data to third parties must be in line with national regulations 5 Promotional materials and/or information destined for patients, healthcare professionals, and pricing and reimbursement bodies must be complete, balanced and easily understood by the intended audience You are also required to comply with national and international legislation relating to clinical trial disclosure The World Health Organisation (WHO) statement on reporting timeframes for clinical trials follows similar lines (http://www.who.int/ictrp/results/reporting/en/). However, when we examine the actual regulatory requirements for the registration of trials and reporting of results in the European Union (EU), United Kingdom (UK), United States of America (USA), Japan, India and Africa, there are marked differences between regions. For the sake of brevity, only two countries (Japan and India) have been given in Asia: Global registration standards Host country or region EU Jurisdiction Registration portal Public portal Mandatory? * Information ** Timescale EU EudraCT https://eudract.ema.europa.eu EU Clinical Trials Register (EU-CTR) here Yes Not required: Date of first enrolment UK Global Same No All USA Global International Standard Randomised Controlled Trial Number (ISRCTN) registry http://www.isrctn.com/ National Institutes of Health (NIH) Clinicaltrials.gov Same Yes (for trials under FDAAA 801) ‘Protocol Data Element Definitions’ outlined here Japan Japan Japan Primary Registries Network (JPRN) http://rctportal.niph. go.jp/ No All + Items according to local needs to form a set of 85 registration items India India University Hospital Medical Information Network (UMIN CTR) http://www.umin.ac.jp/ctr/ Japan Pharmaceutical Information Center - Clinical Trials Information (JapicCTI) http://www.japic.or.jp/ Japan Medical Association Center for Clinical Trials (JMACCT CTR) http://www.jmacct.med.or.jp/ Clinical Trials Registry – India http://ctri.nic.in/ Trial must be registered before the first patient is recruited. Not specified (encouraged to be before first patient enrolment) No later than 21 days after enrolment of the first participant (with some exceptions here) Not specified (recommended on or before first patient enrolment) Same Yes South Africa (SA) Africa Pan African Clinical Trial Registry (PACTR) pactr.org (includes South African National Clinical Trial Register (SANCTR)) Same No All + additions http://www.who .int/bulletin/volu mes/86/8/08010808/en/ All (mandatory in SA) Not specified (recommended before enrolment of first participant) Not specified (“ideally” before the enrolment of the first participant) * In all cases, this refers to studies that meet the WHO/ICMJE 2008 definition of a clinical trial ** Deviation from WHO Trial registration dataset. The minimum amount of trial information that must appear in a register in order for a given trial to be considered fully registered. There are currently 20 items in the WHO Trial Registration Data Set. http://www.who.int/ictrp/network/trds/en/ 6 Reporting of trial results Publication of summary results Portal EudraCT clinicaltrials.gov General requirements Ref Annex IIIa of regulation EU No 536/2014. The results for phase I-IV clinical trials are to be posted: o summary results and layperson summary – 12 months after the end of the trial o the clinical study report of trials – 30 days after the decision on marketing authorization or withdrawal Summary results must be published, whether the drug has been approved for use or not, no later than 12 months after the Completion Date. Exemptions Phase I trials, conducted solely in adults and which are not part of an agreed Paediatric Investigation Plan (PIP) o Protocols, subject information sheets, Investigational Medicinal Product Dossiers (IMPDs) and investigator brochures, may be deferred differentially o Exceptions to publication are personal data of trial subjects, IMPD quality/manufacturing section, and the financial contracts Submission of results may be delayed if either: o The trial reached its Completion Date before the drug (or biologic, or device) is initially approved, licensed, or cleared by Food and Drug Administration (FDA) for any use (no later than 30 days after the drug or device is approved, licensed or cleared) o The trial studies a new use of an FDA-approved drug and manufacturer filed or will file within 1 year an application to FDA for approval or clearance of that use. Results deadline: 1) The earlier of the date that is 30 days after the date that: The new use of the drug or device is approved, licensed, or cleared by FDA FDA issues a letter for the new use of the drug or device, such as a complete response letter The application or premarket notification for the new use is withdrawn without resubmission for no less than 210 days or Japan India No legal requirement However, member companies of the Japanese Pharmaceutical Manufacturers Association (JPMA) are ‘required’ to abide by the international ‘Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases’ Since April 2009, the Japanese Ministry of Health, Labour and Welfare (MHLW) has issued and applied the latest version of the ‘Ethical Guidelines for Clinical Research’. Although only administrative guidelines without legal force, they are considered to be 'soft’ law and perceived as having effectiveness. Not currently a requirement 2) 2 years after the date a certification is submitted, if none of the events listed above has occurred n/a n/a 7 Publication of full data set Portal Requirements Exemptions EudraCT/EMA The European Medicines Agency (EMA) is the only jurisdiction to date that has developed a framework for the public release of study reports (upon request). The following (including appendices) will be available upon request: module 2.5 (clinical overview) module 2.7 (clinical summary) module 5 (clinical study reports (CSRs) • Clinical reports available on-screen for any user, with a simple registration process; • Downloadable clinical reports available to identified users Commercially confidential information (proposed by the applicant or market authorisation holder and agreed by the EMA) Currently – individual patient data (IPD) (see ‘future implementation’) Future implementation The EMA will also work to find the most appropriate way to make IPD available, in compliance with privacy and data protection laws. The world is still very heterogeneous Most large pharmaceutical companies now have their own clinical trial data portals. In some cases these go beyond the local regulatory requirements. A number of companies – Astellas Pharma Inc., Bayer AG, Boehringer Ingelheim GmbH, Eisai Co. Ltd, GlaxoSmithKline, Eli Lilly and Company, Novartis AG, Roche Pharmaceuticals, Sanofi S.A., Takeda Pharmaceutical Company Ltd, UCB and ViiV Healthcare – have formed an alliance called Clinical Study Data Request – https://www.clinicalstudydatarequest.com/ – where researchers can request anonymised patient-level data from these companies. The requests are reviewed by an independent panel. Links to the major company policies and portals are provided below: GlaxoSmithKline – http://www.gsk.com/en-gb/our-stories/how-we-do-randd/data-transparency/ Roche Pharmaceuticals – http://www.roche-trials.com/ Pfizer – http://www.pfizer.com/research/clinical_trials/trial_data_and_results Novartis AG – https://www.novartis.com/our-work/research-development/clinical-trials/clinical-trial-information-disclosure Sanofi SA – http://en.sanofi.com/rd/clinical_trials/our_data_sharing_commitments/our_data_sharing_commitments.aspx Merck – http://www.merck.com/clinical-trials/policies-perspectives.html AstraZeneca – http://astrazenecagrouptrials.pharmacm.com/ Conclusion There is no doubt that we are becoming a more open society. However, differences in clinical trial registration and the reporting of results between countries and regions are still slowing the progress of transparency. The absence of a level playing field between countries or regions is continuing to hinder the flow of information and leads ultimately to market differences. The International Conference on Harmonisation (ICH) is now 25 years old. ICH has become an extraordinarily effective tool. Openness and results publication with dissemination of data is in its infancy. Attitudes may be changing, but we still have to travel a long way from attitude to legislation in search of a global standard. What are your thoughts on the international standards for clinical trial publication? Do you agree that better harmonisation is required globally? Are the current systems adapting quickly enough to reflect public opinion? Get in touch [email protected] 8 Pharmaceutical Medicine and Market Access in a Free Market Economy: One of Many Opportunities for the Faculty of Pharmaceutical Medicine in North America? Authors Dr Peter Gardiner MB ChB, MRCP, FFPM (U.S.A.) Senior Pharmaceutical Physician and President, Gardiner Consulting, LLC Dr Declan O’Callaghan MB BCh BAO (Republic of Ireland) Medical Director, Wyeth Pharmaceuticals Ltd Market access As pharmaceutical physicians, we have always been involved in the cost of drug development – typically being asked how we can reduce clinical trial expenditures and yet complete study enrolment and analysis faster. However, we are becoming increasingly involved in advising on the acquisition and interpretation of clinical data that supports economic modeling and, ultimately, the pricing of the drugs that companies are developing and commercialising. Evaluating cost-effectiveness and supporting the efforts of our pricing and reimbursement colleagues are becoming equally as essential as demonstrating clinical efficacy and safety. “Market Access” is an area of drug development and commercialisation with which we all need to be increasingly familiar, as the focus shifts to “who pays the bill?” It is curious that our industry has focused extensively on educating prescribers about the benefits of medicines, yet these individuals are not directly accountable for the costs of their therapeutic decisions - it is always easier to spend other people’s money than your own! Whilst it is hard to convince governments to approve and reimburse medicines, it is harder still to persuade insurers to list them on formularies, and hardest of all to persuade patients to pay for the entire cost of the medicine themselves. One size does not fit all. Market access models range from centralised, nationally controlled systems, such as in France, through mixed systems with national price setting but regional formulary processes governing ultimate access (e.g. Canada and United Kingdom), to the decentralised system in the United States of America (USA). Although this is changing in the USA, with rapid consolidation of health care insurers and the increase in the insured population through the Affordable Care Act.1 Health Technology Assessment (HTA) is a critical component, if not a requirement, for market access in almost every major pharmaceutical market. The United Kingdom’s National Institute for Health and Care Excellence (NICE) has been a pioneer in guideline and standard setting in this regard.2 In the USA, the Boston-based, non-profit Institute of Clinical and Economic Review (ICER) has been credited with helping some drug plan managers secure big discounts on new hepatitis C drugs, including sofosbuvir.3 Whilst there is no doubt sofosbuvir has revolutionised the treatment of patients with hepatitis C, can the USA health care system tolerate a drug initially priced at $1,000 per tablet (or $134,000 for the minimum recommended 12 weeks of treatment)?4 The 120,000 patients reportedly treated to date are less the issue, compared to the 1.4 million infected, diagnosed, but not treated and the additional 1.5 million infected but not yet diagnosed.5 It has recently been reported that yet-to-be-published recommendations from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America will include, for the first time, cost-effectiveness language and conclude that new treatments for hepatitis C are cost-effective.6 Interestingly, the costs referenced in this assessment are apparently after discounts. 9 This debate over the cost of drugs for rare diseases extends to other orphan diseases. The US Food and Drug Administration granted orphan drug status to 43 medicines in 2014 – 10 years ago only 10 therapies had orphan status.7 Worldwide sales of orphan drugs were less than $20 billion in 2000, but are forecast to be of the order of $176 billion by 2020.7 Synageva has recently submitted its first product for approval – a drug to treat a disease affecting just 3,000 people in the developed world.7 It is perhaps not surprising that Synageva is led by an ex-Genzyme executive; Genzyme pioneered the approach to developing drugs for rare diseases and marketing them at high prices, with the introduction of its therapy for Gaucher’s disease in the 1990s. Of note, ICER has recently received a $5.2 million grant from a Houston philanthropic foundation to expand their study of whether new drugs are worth the price tag.8 One of the next projects will be to assess the new, potent cholesterol-lowering drugs, known as PCSK9 inhibitors. The first of these drugs, alirocumab, was just approved by the FDA on July 24, 2015.9 Given the huge potential market for this class of drug, the implications for health care budgets could be overwhelming – an initial price of $40 per day ($14,600 per year) has been reported.10 Following a recent, positive Committee for Human Medicinal Products opinion, alirocumab has been submitted to the European Medicines Agency for approval. The costs of new drug research and development and, in particular, the cost of failure, are often used to justify the high price of pharmaceutical products. This issue received attention recently with the disclosure of an updated assessment from the Tufts Center for the Study of Drug Development (CSDD).11 Tufts CSDD calculated the cost of developing and gaining market approval for a new drug as $2.6 billion. This is a substantial increase from their 2003 estimate of $802 million and the methodology has certainly been criticised; for example, they included $1.2 billion as the cost of capital, with only $1.4 billion attributed to actual funds spent on research and development.12 Clearly, cost-effectiveness and market access are topics of relevance to all pharmaceutical physicians, regardless of where in the world we work. The Faculty of Pharmaceutical Medicine is well placed to serve as an educational and mentoring resource for this and many other issues of relevance to our day-to-day work and to our continuing professional growth and development. Pharmaceutical Medicine in the USA – structure, organisations and resources Given the size and scale of the N American pharmaceutical industry and marketplace, recent discussions by the FPM International Committee, as well as at the FPM Board level, led to an initial outreach in 2014 to those members and fellows of the FPM who live and work in N America. Of approximately 100 physicians contacted formally by the FPM, about 20 responded and a number of informal teleconferences were held. The principal topics discussed included opportunities for networking, the role of the FPM in education and training, and revalidation for UK-licensed physicians working in N America. A face-to-face meeting of interested and available colleagues was held in June, during the recent Drug Information Association (DIA) 2015 meeting in Washington DC. We were very fortunate to be joined, in-person, by Dr. Keith Bragman, President of FPM and Dr. Robert Hardi, President of the Academy of Physicians in Clinical Research (APCR). The vision of APCR is that clinical research is performed ethically, responsibly, and professionally everywhere in the world. APCR’s mission is to promote excellence in clinical research and is the leading organisation championing the interests and perspectives of clinical research professionals. APCR plays an active role in public discourse of clinical research and in raising awareness of the issues important to clinical research professionals.13 APCR’s focus is on clinical research and a substantial proportion of its members are academic clinical investigators. There is currently no professional organisation in the USA directly representing the interests of physicians in the pharmaceutical (or 10 medical device) industry. The FPM N American Network meeting held in Washington DC was an interactive, brain-storming session that covered a variety of topics. These included: • • • • • How can the FPM effectively represent the needs and views of its North American members? How can the views and needs of the N American FPM community, and of other physicians working in the pharmaceutical, medical device and allied businesses, be effectively communicated to the FPM and, as appropriate, incorporated into the FPM’s policies, practices and priorities? Are there opportunities beyond networking, education/training & revalidation? Are there opportunities for collaboration with other organisations, for example: APCR, International Federation of Associations of Pharmaceutical Physicians (IFAPP), DIA? What is the level of interest in continuing the FPM outreach in N America and how to do so? In addition to Drs. Bragman and Hardi, we were joined by a number of members and fellows of the FPM, as well by representatives of IFAPP and DIA. Feedback was, in general, positive and it was felt that the dialogue amongst interested members and fellows in N America should continue. All suggestions and input regarding this effort are welcome. Some of the ideas under consideration include exploring what motivates the current FPM membership in N America to remain members or fellows and what are the demographics of the group, in terms of location, current and former employment, experience, etc. Also, pharmaceutical medicine has limited recognition in the USA and is not considered an established medical specialty, as it is in the UK. So, for example: how might FPM contribute to creating interest in and awareness of the specialty? In addition to the groups represented at our introductory meeting, it may be appropriate to consider appropriate engagement with the FDA or other interested parties, such as the Institute of Medicine. With the aging population and increased longevity, the demands and stresses on health systems in the USA, and elsewhere in the world, will continue to increase. As an established, global organisation representing the varied medical roles and functions within pharmaceutical medicine, the FPM has the potential to play a critical role in N America. Please send your comments and suggestions regarding the most appropriate roles for the FPM in N America to the Faculty at [email protected]. References 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Affordable Care Act; March 2010; www.hhs.gov/healthcare/rights [Accessed 10 August 2015] National Institute for Health and Care Excellence; www.nice.org.uk/about [Accessed 10 August 2015] Institute of Clinical and Economic Review; www.icer-review.org/ [Accessed 10 August 2015] Sovaldi® (sofosbuvir) Prescribing Information; March 2015 T Brennan, MD, CVS Caremark; Boston BioTech CMO Meeting; presentation - Boston CMO Network; May 2015 Hepatitis C drugs called cost-effective; Boston Globe; July 14, 2015 High prices for drugs to treat rare diseases take a toll; Boston Globe; May 12, 2015 Rising US drug prices are focus of research grant; Wall Street Journal; July 21, 2015 FDA approves Praluent to treat certain patients with high cholesterol; FDA News Release July 24, 2015; www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455883.htm [Accessed 10 August 2015] Regeneron and Sanofi Announce FDA Approval of Praluent® (alirocumab) Injection, the First PCSK9 Inhibitor in the U.S., for the Treatment of High LDL Cholesterol in Adult Patients; Press Release July 24, 2015; www.prnewswire.com/news-releases/regeneron-and-sanofi-announce-fda-approval-of-praluent-alirocumabinjection-the-first-pcsk9-inhibitor-in-the-us-for-the-treatment-of-high-ldl-cholesterol-in-adult-patients300118572.html [Accessed 10 August 2015] How the Tufts Center for the Study of Drug Development pegged the cost of a new drug at $2.6 billion – Backgrounder; November 18, 2014; http://csdd.tufts.edu/files/uploads/cost_study_backgrounder.pdf Avorn J. The $2.6 billion pill – methodologic and policy considerations. N Engl J Med 2015;372:1877-9 Academy of Physicians in Clinical Research; www.apcrnet.org/FunctionalMenuCategory/AboutAPCR.aspx [Accessed 10 August 2015] 11 A tribute to Dr Jack Watters Dr Keith Bragman President Dr Jack Watters, Vice President Pfizer, New York and Trustee of the Faculty of Pharmaceutical Medicine (b 1952; q University of Edinburgh 1977), died after a short illness on the 30th June 2015. Dr Jack Watters died earlier this year after a short illness from advanced cancer. I, for one, will miss his humour, self-deprecating style and wise contribution to the Faculty Board of Trustees. After first qualifying in medicine, working in Edinburgh and Basel, Jack moved to New York in 1989 and subsequently became a US citizen. He rose to become Group Medical Director for Sterling Winthrop, where he had global responsibility for the portfolio. He subsequently moved to Pfizer in 1994. He passionately believed in the power of the industry to make a positive contribution to society. He became a Vice President with responsibility for the company’s external medical affairs. This included the Diflucan (fluconazole) franchise, which contributed to people living with HIV and Aids. He also led Pfizer’s approach to healthy ageing, established a centre of excellence in paediatrics, and maintained the company’s contribution to clinical care across the world. So many individuals are living longer and healthier lives because of Jack’s commitment to medical care. He was an activist for equal rights, he served on the board of the American Federation for Age and Research (AFAR), and he sat on the health technology advisory panel for the University of Strathclyde. Three years ago, he joined the Faculty Board of Trustees. Jack always believed that the Faculty was responsible for the principles by which pharmaceutical medicine should be practised, and that, first and foremost, we had an obligation to the patient and society. I used to see Jack regularly at Faculty Board meetings. We used to debate the issues of the day. Jack was always practical and understood the implications of the bigger picture. He was widely read, a thoroughly decent human being, and a true humanist. He will be greatly missed. 12 Pharmaceutical Medicine in Africa Authors Prof Bernd Rosenkranz MD PhD FFPM (South Africa) Head, Division of Clinical Pharmacology, Faculty of Medicine and Health Sciences, Stellenbosch University, and President, Fundisa African Academy of Medicines Development Dr Michael Reid MBChB MSc MedSci PG Dip Pharm Med (South Africa) Senior Medical Manager South Africa and Sub-Saharan Africa, Pfizer Laboratories (Pty) Ltd Dr Elizabeth Allen BSc (Hons) Pharmacy MPH (Epi) (South Africa) Senior Clinical Research Manager, Malaria Clinical Research Group and Project Manager, Global Health Trials South Africa, Division of Clinical Pharmacology, Department of Medicine, University of Cape Town Pharmaceutical economic environment in Africa According to a McKinsey Report, Africa is one of the world’s fastest-growing economic regions, with a rise in its pharmaceutical industry value from $4.7 billion in 2003 to $20.8 billion in 2013.5 Africa’s estimated growth rates between 2013 and 2020 are in the range of 6 and 11% for prescription drugs, generics, over-the-counter (OTC) drugs and medical devices. The growth in medical care as a whole is reflected in the acquisition of 70,000 new hospital beds, 16,000 doctors, and 60,000 nurses in Africa between 2005 and 2012. Besides the well-known burden of infectious diseases (HIV/AIDS, tuberculosis, malaria and tropical diseases), non-communicable diseases (NCDs) are increasingly important in Africa. NCDs accounted for 28% of morbidities and 35% of mortalities in Africa in 1990, with a projected rise to 60% and 65% respectively by 2020.10 Africa is, however, a very diverse continent of 54 countries, each with its own economic landscape and political complexities. The top 5 pharma markets (billion US-$, IMS Health 2014 estimates) – South Africa (4.9), Egypt (3.9), Algeria (3.5), Morocco (1.8) and Nigeria (1.2) – account for about 70% of the total African market value. Within each country, there are major differences between the rich and the poor, with major cities responsible for a large part of the economic growth. The oil price collapse and crises, such as the recent Ebola outbreak, contribute to economic instability and regional differences. As everywhere else, pharmaceutical companies in Africa are exposed to mergers and acquisitions, joint ventures, strategic alliances, partnerships, and private-equity deals. South African generics company Aspen Pharmacare has grown to be one of the top ten generic companies in the world. Such expansion of the local pharmaceutical industry requires trained pharmaceutical specialists to support it. The bigger multinational pharmaceutical companies are increasingly active in drug production and clinical trials across Africa. According to McKinsey, more than 300 companies have drug manufacturing sites on the continent.5 Clinical trials across all phases have a long tradition in South Africa in particular, with an estimated annual value of about 1.3 - 2 billion Euro.3 About 270 new trials start every year, and 550 trials are active in the country at any given time.8 13 Impact on pharmaceutical industry In the industry, these developments have led to the establishment of medical departments within pharmaceutical companies and subsequently of contract research organisations (CROs) during the 1980s. In South Africa, physicians working in the pharmaceutical industry were organized in the South African Association of Pharmaceutical Physicians (SAAPP), which had 83 members in 2005. This organization is currently being re-activated after a period of dormancy. Clinical research specialists meanwhile are represented by the South African Clinical Research Association (SACRA), an active nonprofit organization that has regular consultation with the regulatory body about pertinent issues, is involved with the move towards the registration of Good Clinical Practice training providers and hosts an annual conference. Clinical research in sub-Saharan Africa is mainly performed by international and local companies, but increasingly also by clinicians, in the form of investigator-initiated trials. There is a clear need for more and better clinical research in Africa addressing the major contributors to the burden of disease in this part of the world.2,7 Another challenge is the ever changing regulation of the pharmaceutical marketplace. In South Africa, certification with the Marketing Code Authority (MCA) established in 2014 is a requirement, and pharmaceutical professionals must comply with its code of conduct. Employees must be adequately trained. Unfortunately, other African countries do not yet have such an oversight body and hence minimal guidance on marketing of medicines. Medicines regulation Regulatory agencies in Africa are also struggling. The South African Medicines Control Council (MCC) is the most established regulatory body in sub-Saharan Africa. Because of the increasing complexity of product submissions and the present working model which relies on external reviewers mainly from universities and research institutions, review timelines are long and unpredictable. Delays in clinical trial submissions can also be off-putting to sponsors considering South Africa within their clinical development plans, although typically good recruitment rates may make up for lost time. Legislative amendments to change this situation are leading to the formation of a new agency, the South African Health Products Regulatory Agency (SAHPRA). A critical mass of trained internal and external reviewers will be required to carry out the regulator’s mandate. For low and middle income countries, WHO promotes the establishment of regional multinational joint regulatory organizations to reduce the delayed uptake of new medicines, vaccines and medical innovations.6 Teaching and training of competencies in medicines development and regulation The increasing need for experts and accredited specialists in pharmaceutical companies, clinical trial groups and regulatory agencies across Africa needs to be addressed with urgency. In the medical affairs departments for example, pharmaceutical companies across Africa have to hire personnel without necessary professional exposure and competencies for their roles. Thus, there is a reliance on “on the job training”. As the pharmaceutical landscape evolves, the role of the pharmaceutical specialist in translational medicine has become ever more important. Principles of evidencebased medicine are being applied more regularly in patient management, requiring a pharmaceutical specialist who understands the science of medicines development and is able to communicate this into clinical practice. Thus, with limited training in pharmaceutical medicine in Africa, “on the job training” will not be adequate to provide all necessary competencies. Whereas Pharmaceutical Medicine is not a specialty in any of the African countries, Clinical 14 Pharmacology has been recognised in South Africa as a full medical specialty since 2009.9 In 2011, the Faculty of Pharmaceutical Medicine exported its Diploma in Pharmaceutical Medicine examination to South Africa as a pilot project. Unfortunately, this initiative has subsequently been abandoned due to the lack of medically qualified candidates prepared to take this examination. However, this may be revisited in the future. Regulatory science and medicines development are not taught at undergraduate level in Africa. However, several South African universities have developed bachelor and/or master courses in regulatory science, drug development, pharmacoeconomics, pharmacovigilance and pharmaceutical affairs. In 2010 a fully accredited 2-year diploma programme in medicines development was started at Stellenbosch University following the PharmaTrain syllabus and standards. As the first non-European training course, this programme is accredited as a Centre of Excellence by the PharmaTrain Federation. Non-academic training programmes and workshops in medicines development and drug regulation are also offered by the Fundisa African Academy of Medicines Development (www.fundisa-academy.com) which presented the first Clinical Investigator Certificate (CLIC) course according to the PharmaTrain syllabus this year. The MCC will require a new model of staff training, combining capacity building through a blended elearning platform, including mentoring, workplace assignments and specific courses in cooperation with the universities and other training providers. Recommendations for the training of regulatory experts in South Africa were provided by the EU-funded Ecorys Health Consortium. This year, the Institute for Regulatory Science (IRS) was established in the National Department of Health to coordinate training relevant for agency staff, clinical trial specialists and industry employees in the region. Ongoing initiatives for capacity building in medicines development and regulatory sciences in emerging African countries were discussed at the 4th African Regulatory Conference held in Dakar, Senegal in April 2015. Progress has been made in the development of pharmacovigilance in Africa, and some African countries have become members of the WHO Programme for International Drug Monitoring. In 2010, WHO designated the University of Ghana Medical School as a WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance. An initiative with no borders is The Global Health Network, which provides a website forum for clinical investigators and their teams to address technical competence, and knowledge-sharing.1 This offers open access, peer-reviewed e-learning products, tools and templates, articles, discussion forums and a professional membership scheme that supports career development in clinical trials. Since its launch in 2010 at Oxford University, this website has become widely popular, with more than 230,000 visits recorded to date. Following a workshop at the 17th World Congress of Basic and Clinical Pharmacology (WCP2014) in Cape Town4, PharmaTrain Federation and the International Federation of Associations of Pharmaceutical Physicians & Pharmaceutical Medicine (IFAPP) jointly established a Working Group on Education of Medicines Development in Low and Middle Income Countries. Zimbabwe, Ghana and Ethiopia were selected as initial African pilot countries in which to consider expanding the IFAPP-PharmaTrain remit to these regions. References 1. 2. 3. The Global Health Network. Global Health Trials. https://globalhealthtrials.tghn.org/ (accessed 21 July 2015) Isaakidis, P, Swingler, GH, Pienaar, E, Volmink, J, Ioannidis, JP. Relation between burden of disease and randomized evidence in sub-Saharan Africa: survey of research. BMJ 2002 324(7339);702-706 Kahn, M, Gastrow, M. Pharmacologically active: clinical trials and the pharmaceutical industry. S Afr Med J 2008 98(2);114-116 15 4. Kerpel-Fronius, S, Rosenkranz, B, Allen, E., Education and training for medicines development, regulation and clinical research in emerging countries. Front Pharmacol 2015 6:80. doi:10.3389/fphar.2015.00080 5. McKinsey & Company Report. Insights into Pharmaceuticals and Medical Products in Africa: A Continent of Opportunity for Pharma and Patients, 2015. www.mckinsey.com/insights/health_systems_and_services/africa_a_continent_of_opportunity_for_pharma_an d_patients, 2015 (accessed 03 July 2015) 6. Rago, L. Regulatory appraisal of biological medicines and harmonization initiatives for availability and access. 17th World Congress of Basic and Clinical Pharmacology (WCP 2014), Cape Town, South Africa; Biological medicines development (PharfA Symposium 3) 7. Siegfried, N, Clarke, M, Volmink, J. Randomised controlled trials in Africa of HIV and AIDS: descriptive study and spatial distribution. BMJ 2005 331(7519);742-747 8. Strugo V, Katsoulis L, Chikoto H, Southwood T, Coetzee M. Conducting clinical trials in South Africa. In: Chin R & Bairu M (eds): Global Clinical Trials (Chapter 12), Elsevier Press, 2011 9. Walubo, A, Barnes, K, Kwizera E., et al Clinical Pharmacology becomes a specialty in South Africa. S Afr Med J 2013 103;150-151 10. WHO, African Health Observatory. www.aho.afro.who.int/profiles_information/index.php/AFRO:Disease_burden_-_Noncommunicable_diseases_and_conditions, 2015 (accessed 03 July 2015) 16 Pharmaceutical Medicine in the Asia-Pacific region Authors Dr Victoria Elegant FFPM LRCP MRCS DRCOG (China) Vice-President, Medical and Regulatory Affairs, Asia-Pacific, Baxter Asia-Pacific Dr Pippa Biswas MFPM (U.K.) Director, Symogen Ltd Dr Ritu Sahni FFPM MRCP (Australia) Independent Pharmaceutical Physician The Asia-Pacific region is extremely vibrant, fast moving, and characterised by its extreme heterogeneity from a medical, regulatory and economic perspective. It is also unique, in that several countries in the region require local clinical data on their own populations in order to register compounds, and also have mandatory requirements for post-marketing surveillance studies. It includes both developed countries – South Korea, Australia, New Zealand, Taiwan, Hong Kong, Singapore, Japan, and developing countries – China, India, Vietnam, Philippines, Indonesia, Malaysia, Thailand, and others. There are 35 countries in the region, each with their own culture and language – in many countries such as India and China, there are multiple regional languages. All countries in Asia-Pacific (APAC) require a New Drug Application (NDA) to contain sufficient data to support the efficacy, safety and quality of a pharmaceutical product before their regulatory agencies can approve its marketing authorisation. Clinical data submitted to support efficacy and safety of the pharmaceutical product should be generated from well-designed trials conducted in accordance with Good Clinical Practice (GCP). They should be robust enough to stand up to reviews by wellestablished regulatory agencies such as the US Food and Drug Administration (FDA) or European Medicines Agency (EMA). There are however certain specific considerations that need to be taken note of when preparing for NDA filing in countries in this region. Many APAC countries require the prior marketing authorization approval in a reference country/countries and/or the country of origin of a pharmaceutical product has been obtained, before they in turn issue their approval based on a summary review complemented by such a reference approval. As such, the Certificate of Pharmaceutical Product (CPP) is required as part of the NDA dossier in these countries. Some countries will require the CPP at the time of submission, while some countries can accept an initial submission dossier without a CPP and start their review first but require that the CPP be furnished at a later period so that they can issue their approval after their summary review. There is little harmonisation between the regulatory systems in each country. In the ASEAN region – Singapore, Malaysia, Thailand, Vietnam, Brunei, Myanmar, Philippines, Cambodia, Laos and Indonesia, much work is ongoing to harmonise requirements and regulations. Most countries have adopted the ASEAN CTD for submissions. The ASEAN region also has specific Zone IV stability requirements. 17 Local Data Requirements Local Phase I/ Pharmacokinetic (PK) requirements Local subject number in Phase III Post marketing surveillance China Korea Taiwan Vietnam India Yes – local PK and it may be conducted in parallel with Phase III study I – 20 subjects Per regulations: Phase III – 100 (small molecules) and 300 (large molecules) in active arm + statistical significance Maybe Not required Not required Not required Not required 30 to 50 in active arm (in practice) Per regulations: If total n>200, 5% or 30 whichever is lower, If total n < 200, 10% or 10 whichever is lower ~30 in active arm (in practice) 100 in total Yes No No Yes Table 1: Requirements for local clinical data required for NDA submission India has updated its regulations recently, following accusations that there were many clinical trials being conducted in India without adequate protection for subjects. The new regulations mandate fixed compensation according to a specific formula, review of trials by the Drug Controller General of India (DCGI), and video taping of subject consent. Initially almost all trials in India stopped while the regulations were being updated, but in the last year the number of companies conducting clinical studies in India has increased. There are excellent centres with investigators experienced in conducting trials. The ministry is also taking steps to accredit and register clinical trial centres. China is currently possibly the toughest regulatory environment, with imported new chemical entities (NCEs) taking up to six years for registration. Local clinical trials to collect local data are required, and the backlog of application for Clinical Trial Permissions due to the high volume and relative under-staffing at the China Food and Drug Administration (CFDA) is proving frustrating for many companies. The CFDA recently released guidelines for the conduct of multi region clinical trials (MRCT), with at least three countries including China, for unmet medical needs and life threatening disease, which may help to speed up registrations. This month, a new guidance was issued. This describes (i) launching a pilot programme of a market authorisation holder (MAH) system for drugs, (ii) allowing synchronous in-country clinical trials for new drugs that have not yet been marketed overseas, and (iii) adopting qualified clinical data obtained directly from multi-centre clinical trials. Overall, the reform emphasises improving the efficiency of the review system, resolving the drug application backlog by the end of 2016, improving the quality of the generic drugs, encouraging the development of innovative drugs and creating a more transparent review and approval process. Japan has required local data for many years, and is now open to multi-region or global trials including Japanese patients, provided the number of Japanese patients is sufficient to meet the Japanese regulatory requirements. Last year, the Pharmaceutical Affairs Law was revised in order to strengthen safety of drugs and device registration. It is now the third largest market in the world, after the US and China, and so remains very attractive. In Australia, current data suggest that around 1000 new clinical trials are commenced in Australia each year by pharmaceutical, biotechnology and medical device companies, representing a $1 billion investment. The top 10 global pharmaceutical companies are responsible for 20% of this investment.1 18 There has been a shift in the type of clinical trial activity conducted in Australia. Historically, Phase III studies have dominated. However, since 2008, there has also been a significant increase in early-phase activity, reflecting global trends, along with local capabilities in early-phase clinical research. Australia boasts a quality medical research infrastructure and a skilled workforce, a world-class healthcare system, a stable socio-economic environment, an ethnically diverse population and a strong intellectual property regime. An efficient regulatory system, including a rapid clinical trials approval system, its proximity to Asia, a strong mechanism of support services, streamlined processes and globally competitive tax incentives for research and development (R&D) investment, all contribute to making it attractive for conducting trials. There is a national focus on continuous improvement of the industry through government reform and policy innovation. Two significant examples are the Therapeutic Goods Administration (TGA) reforms and the Australian Government Clinical Trials Initiatives. The TGA is responsible for the regulation of medicines and medical devices in Australia. In December 2011 a comprehensive package of TGA reforms, drawn together by the Australian Government, were announced in TGA reforms: A blueprint for the TGA’s future.2 The blueprint reforms aim to improve community understanding of the TGA’s regulatory processes and decisions, enhance public trust and confidence in the safety and quality of therapeutic goods. A four-year implementation plan was put into place, focusing on the areas of communication and stakeholder engagement, advertising of therapeutic products, complementary medicines, medical devices and promotion of therapeutic products. The Australian Government, in partnership with industry and other stakeholders, is currently undertaking initiatives (Australian Government Clinical Trials Initiatives) to improve the clinical trials environment in Australia, whilst maintaining the highest quality and ethical standards.3 These include a focus on reducing study start-up times, working towards a nationally consistent approach to clinical trials, boosting patient recruitment and developing a standard list of costs for clinical trials. There are a number of ongoing activities aimed at advancing education in pharmaceutical medicine in the region. There are courses already available in Beijing, China, Osaka, Japan and at the University of New South Wales (UNSW), Sydney, Australia. The recently formed cross industry group in China – China Medical Affairs Network – held a 3 day training course in Shanghai in December 2014 which had 30 attendees, and the group is intending to repeat this as it was well received. Discussions are ongoing with the group and the UNSW to customise the offering from UNSW to meet the needs of the Chinese environment4. Since the course and assessments are all online, we are confident it can be adapted for China and potentially the rest of the region. Education of this kind is a critical requirement to keep pace with the growth in the industry, and in particular the growth in clinical trials and medical affairs activities needing experienced, well trained people. In summary, the region is fast moving, with a constantly changing environment, and with many countries taking steps to improve their healthcare, including strengthening registration and safety requirements. It is critical to have people on the ground, who keep abreast of all the changes and can help shape the environment in order to bring much needed therapies to patients in the region. References 1. 2. 3. 4. Clinical Trials Capability Report, Australian Trade Commission, Australian Government, May 2015 Delivering Reforms- Implementation plan for TGA Reforms: A blueprint for TGA’s future, Australian Government, July 2012 https://www.australianclinicaltrials.gov.au/australian-government-clinical-trials-initiatives Opinions Concerning the Reform of the Review and Approval System for Drugs and Medical Devices Issued by the State Council (the “Opinions”, Guo Fa Notice [2015] No.44) 19 Advancing Education and Training in Pharmaceutical Medicine in Europe Authors Dr Dominique Dubois MD BCPM FFPM (Belgium) Physician Specialist in Pharmaceutical Medicine, Vice-Chairman Pharmed post-graduate programme in Pharmaceutical Medicine and Medicines Development Sciences Dr Jens Wurthner MD PhD FFPM (Switzerland) Lead Clinical Program Leader, Translational Clinical Oncology, Novartis Institutes for BioMedical Research (NIBR) Dr Piotr Krzeski MD PhD FFPM (Poland) Medical Director, Medpace Dr Fergal Donnelly MD FFPM (Belgium) Principal Scientific Officer European Commission DG Research & Innovation The PharmaTrain education and training initiative Competency-based education is founded on competencies, or predefined abilities, as outcomes of the curriculum. Competency is defined as the observable ability of any professional, integrating multiple components such as knowledge, skills, values 1 and attitudes. Alignment of competencies is essential for maintaining the high quality of interprofessional education and training in medicines development and clinical research.2 Training in integrated medicines development, based upon relevant competencies, is a major mission of the Innovative Medicines Initiative (IMI) of the European Union. This is Europe’s largest public– private initiative, and aims to speed up the development of better and safer medicines for patients.3 The Faculty is a public partner within the PharmaTrain project, which is supported by the Innovative Medicines Initiative Joint Undertaking (IMI JU) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). This consortium has developed a syllabus for pharmaceutical sciences that is the basis for new European programmes dealing with integrated drug development.4 PharmaTrain commenced its activities in 2009 as an education and training project funded by IMI and has implemented reliable standards for high-quality postgraduate education and training in medicines development. This will ensure the continued competence of medicines development scientists and clinical investigators. Learning outcomes are embedded in the PharmaTrain assessment process of training programmes and PharmaTrain Centre of Excellence recognition. The PharmaTrain Federation is the successor organisation to PharmaTrain and is now in the process of developing PharmaTrain Specialist in Medicines Development Awards, along with PharmaTrain “à la carte” training courses that are tailored to more individual needs. It is one of a great variety of such activities funded by IMI so that future generations of scientists will be fully acquainted with the complexity of pharmaceutical R&D and will promote better collaboration between the different sectors within its long and complex pipeline. 20 The IFAPP commitment to education and continuing professional development (CPD) in Pharmaceutical Medicine The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) is a global federation, strongly devoted – since 2001 – to education in Pharmaceutical Medicine around the world.5,6 In 2013, a working group formed within IFAPP, including members of the Faculty’s International Committee, PharmaTrain, academic institutions, and national member associations, defined a set of core competencies for pharmaceutical physicians and drug development scientists.7 Seven domains and fifty seven competencies in medicines development were identified and mapped against the PharmaTrain Learning Outcomes. A set of core competencies is summarised in the “Statement of Competence”: The pharmaceutical physician and drug development scientist is able to: - Identify unmet therapeutic needs, evaluate the evidence for a new candidate for clinical development and design a Clinical Development Plan for a Target Product Profile. Design, execute and evaluate exploratory and confirmatory clinical trials and prepare manuscripts or reports for publication and regulatory submissions. Interpret effectively the regulatory requirements for the clinical development of a new drug through the product life-cycle to ensure its appropriate therapeutic use and proper risk management. Evaluate the choice, application and analysis of post-authorization surveillance methods to meet the requirements of national/international agencies for proper information and risk minimization to patients and clinical trial subjects. Combine the principles of clinical research and business ethics for the conduct of clinical trials and commercial operations within the organisation. Appraise the pharmaceutical business activities in the healthcare environment to ensure that they remain appropriate, ethical and legal to keep the welfare of patients and subjects at the forefront of decision making in the promotion of medicines and design of clinical trials. Interpret the principles and practices of people management and leadership, using effective communication techniques and interpersonal skills to influence key stakeholders and achieve the scientific and business objectives. The LifeTrain Common Framework for CPD in the biomedical sciences LifeTrain is a new pan-European framework for continuing professional development (CPD) in the biomedical sciences.8 The framework consists of a series of key messages and four sets of agreed principles – one each for professional/scientific bodies, course providers, employers, and individual professionals. The LifeTrain framework focuses on competency profiles, competence assessments and competency portfolios.9,10 The European Medicines Research Training Network (EMTRAIN) – one of the five education and training projects supported by the IMI – conceptualised the LifeTrain framework and developed the course catalogue “on-course®” containing around 7000 post-graduate courses in biomedical sciences (Master’s, short courses and PhD programmes) and incorporating quality standards developed by the IMI education and training projects.11-13 Competency and Pharmaceutical Medicine specialty recognition in Europe Whilst the special and differing competencies of Pharmaceutical Medicine are widely recognised, so far only a few European countries have recognised it as a postgraduate medical specialty with board certification in its own right, namely the UK, Ireland and Switzerland.14 In Belgium, specialists whose names appear on the Register of the Belgian College of Pharmaceutical Medicine are entitled to bear the title of “Physician Specialist in Pharmaceutical Medicine”, and negotiations for recognition by the Higher Council of Specialists are ongoing. 21 Several qualified institutions offer courses that are usually part of an individual’s educational path for those who seek licensure in this specialty. Detailed information on biomedical postgraduate education and training programmes, including short courses (CPD), masters and PhD programmes, can be consulted on the “on-course®” course portal www.on-course.eu History and current state of the art: Examples of Belgium, Switzerland, and Poland Belgium Belgium is an example of a country with advanced recognition and development of the discipline of pharmaceutical medicine. The Belgian Association of Pharmaceutical Physicians (BeAPP) was established in 1972. All members are pharmaceutical medicine professionals working in or for the pharmaceutical industry and a majority are fellows or candidate fellows of the Belgian College of Pharmaceutical Medicine (BCPM).15 BeAPP became a member of IFAPP at its foundation in 1975 and has been permanently represented on its Executive Committee since then. The association is opening up to non-MDs active in pharmaceutical medicine, this mainly in response to increased requests of e.g. Medical Science Liaison (MSL) and other non-MD professionals who feel attracted to the domains and topics BeAPP is covering. The Pharmed post-graduate programme in Pharmaceutical Medicine and Medicines Development Sciences is recognised by the Faculty of Pharmaceutical Medicine as one of few European courses that provide appropriate postgraduate training in pharmaceutical medicine.16 The Pharmed programme follows closely the Faculty’s syllabus of pharmaceutical medicine. Since 2003, the Pharmed course is also accredited by the IFAPP Council of Education in Pharmaceutical Medicine (CEPM). Pharmed successfully passed a detailed assessment of full compliance with the PharmaTrain quality standards, and as a result received the PharmaTrain Centre of Excellence award in November 2011. Efforts to have pharmaceutical medicine recognised by the Higher Council of Specialists are ongoing. The FPM description of the certification routes in the UK serves as a reference the dialogue with our local health authorities.17 The curriculum requirements currently being discussed are to a great extent guided by the Pharmaceutical Medicine Specialty Training (PMST) programme recommendations of the Faculty. Switzerland Switzerland is a country in which the pharmaceutical industry plays a major and longstanding role in the country’s manufacturing business. In 2014, more than one-third of all Swiss exports were pharmaceuticals, and pharmaceutical companies headquartered in Switzerland reached a worldwide market share of $95 billion.18 In terms of employment, the pharmaceutical sector offers 41,900 jobs directly in pharmaceutical companies, and another 130,000 jobs in ancillary industries. Therefore, it may not come as a surprise that this country provides adequate professional organisations in which both physicians and non-physicians can express their interest in the profession, receive training, and contribute to its advancement. Pharmaceutical medicine is also one of 44 accredited medical specialties, with registration by the Swiss Medical Association (FMH, Fédération Médicale Helvétique.19 It is possible to transfer a GMC licence in Pharmaceutical Medicine to the FMH, which is a bureaucratic, but feasible, act; however, proficiency in German is mandatory. 22 The two professional organisations dealing with pharmaceutical medicine are the Swiss Society of Pharmaceutical Medicine (SGPM) and the Swiss Association of Pharmaceutical Professionals (SwAPP). The former was founded in 1997 for physicians in Switzerland with, or in training for, specialisation in Pharmaceutical Medicine. The SGPM is member of the Umbrella organisation SSPT (Swiss Society of Pharmacology and Toxicology). Today the SGPM counts about 150 members, of whom more than 100 are holders of the Swiss specialist title in Pharmaceutical Medicine. The remainder either are in postgraduate training or hold an equivalent certificate.20 SwAPP was founded in 1995 as the professional association for qualified specialists working in one of the many fields of pharmaceutical medicine and drug development. SwAPP members come from pharmaceutical companies, contract research organisations, health care institutions, biotech companies, health authorities and ethics committees. SwAPP welcomes members with an academic background, for example in life sciences, biology, pharmaceutics or a similar field, and physicians, as well as non-academic health professionals.21 Both organisations entertain informal friendly contacts with each other and co-organize an annual symposium. Poland Poland is one of the most prolific countries for industry sponsored clinical research. With 400-500 clinical trial registrations annually, Poland remains one of the most important countries for the conduct of clinical research in Europe and the largest in Central Eastern Europe.22 Despite this, few pharmaceutical companies located their R&D operational centres in Poland. Building of pharmaceutical medicine competencies is mainly focused on investigator training, often limited to Good Clinical Practice. Although medical doctors are involved in regulatory, medical, commercial affairs, project management and pharmacovigilance roles, there is no widely recognized requirement for formalized building of pharmaceutical medicine competency among physicians in Poland. The competency level is growing thanks to growing individual experience to some extent supported by local subsidiaries of international pharma corporations and contract research organisations. Notable educational initiatives in the region, such as the Cooperative European Medicines Development Course (CEMDC), are often hindered by funding issues originating from lack of local medical community and industry support.23 A good number of physicians trained in Poland have taken on pharmaceutical roles in the UK and elsewhere in Western Europe. GCPpl (www.gcppl.org.pl) is the association for clinical research professionals. Though there is a lack of census or survey data, we estimate the number of pharmaceutical physicians in Poland to easily exceed 100. Their role is undermined by lack of any form of formal recognition of their competency. Despite some early efforts by individuals affiliated with the FPM, there exists a widespread misunderstanding of the role of pharmaceutical physicians working in the industry, most often confused with clinical pharmacology or commercial operations.24, 25 Pharmaceutical physicians are denied a licence to practise medicine in Poland by medical governing bodies (Medical Chambers), which not only undermines their role but also pushes them outside the corporate regulations and codes of practice such as Good Pharmaceutical Medical Practice or formal recognition of the need for continued professional education and revalidation. The current situation calls for active contribution of those engaged in the mission of the FPM. References 1. 2. 3. Frank JR, Snell LS, Cate OT et al. Competency-based medical education: theory to practice. Med Teach 2010; 32: 638–645 Silva H, Sonstein S, Stonier P et al. Alignment of Competencies to Address Inefficiencies in Medicines Development and Clinical Research: Need for Inter-Professional Education. Pharm Med 2015; 29:131–140 Goldman M. The Innovative Medicines Initiative: A European response to the innovation challenge. Clin. Pharmacol.Ther 2012; 91(3): 418–425 23 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. The European training syllabus for integrated medicines development sciences. www.pharmatrain.eu/_downloads/Appendix_12_1_PharmaTrain_Syllabus_V1_0_February_2010.pdf [Accessed 29 July 2015] International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP). http://ifapp.org/About-ifapp [Accessed 21 July 2015] Lahuerta J, Lahon H, Lee J, and Stonier P. Proposal for the establishment of the IFAPP Council for Education in Pharmaceutical Medicine. Int J Pharm Med 2001; 15(4):207-208 Silva A, Stonier P, Buhler F et al. Core competencies for pharmaceutical physicians and drug development scientists. Front. Pharmacol. 14 April 2015 http://dx.doi.org/10.3389/fphar.2013.00105 LifeTrain: Driving lifelong learning for biomedical professionals. www.lifetrain.eu Hardman M, Brooksbank C, Johnson C et al. 2013. Lifetrain: towards a European framework for continuing professional development in biomedical sciences. Nature Reviews Drug Discovery 2013; 12:407–408. Hardman M. European initiatives for better training in medicines development. Journal of Medicines Development Sciences 2015;1: 001; http://dx.doi.org/10.18063/JMDS.2015.01.001 [Accessed 27 July 2015] European medicines research training network. www.emtrain.eu [Accessed 27 July 2015] Payton A, Janko C, Renn O et al. on-course® portal: a tool for in-service training and career development for biomedical scientists. Drug Discovery Today 2013; 18 (17–18):803–806. On-course® database. www.on-course.eu [Accessed 27 July 2015] Stonier PD, Silva H, Lahon H. Pharmaceutical medicine: history, global status, evolution and development". Int J Pharm Med 2007;21 (4): 253–262 Belgian College of Pharmaceutical Medicine (BCPM). www.bcpm.be/become-fellowAccessed 23 July 2015] PHARMED post-graduate programme in pharmaceutical medicine/medicines development sciences. www.ulb.ac.be//medecine/pharmed/ Pharmaceutical Medicine Specialty Training www.fpm.org.uk/trainingexams/pmst/trainingland [Accessed 23.7.15] Pharma-Markt Schweiz - Interpharma, 2015 Basel (translated from German) www.fmh.ch/bildung-siwf/fachgebiete/facharzttitel-und-schwerpunkte.html [Accessed 27 July 2015] www.sgpm.ch/cgi-bin/index.pl?l=en [Accessed 27 July 2015] www.swapp.ch/about-us [Accessed 27 July 2015] Gryz M. Clinical Trials in Poland at International Clinical Trials Day. www.gcppl.org.pl [Accessed 26 July 2015] http://cemdc.eu/ [Accessed 26 July 2015] Januszewicz P. What is Pharmaceutical Medicine? Przegląd Medyczny Uniwersytetu Rzeszowskiego 2007;3:298300 Krzeski P. Clinical Trials in Drug Development in Idea-Research-Publication. Medical Students’ Scientific Textbook edited by Gdansk Medical School Bedynko L. and Waszak P. 2015:84-92 Connect with the Faculty... Follow us on Twitter https://twitter.com/FacultyPharmMed Join the LinkedIn group http://www.linkedin.com/groups/Faculty-Pharmaceutical-Medicine-3998698/about Trainees’ LinkedIn group https://www.linkedin.com/groups/Pharmaceutical-Medicine-Trainees-Group-4006693/about Copyright © 2015 Faculty of Pharmaceutical Medicine, All rights reserved. Disclaimer: This newsletter is published by the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the UK. Opinions expressed in articles do not necessarily represent those of the Faculty or its parent Colleges or their policies. 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