E-DRUG: HAI Briefing "From Education to Regulation"
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Event Memo HAI NGO Briefing at WHA 20 May 2009
From Education to Regulation: Innovative Tools for the Rational Use of Medicines
On Wednesday, 20 May, Health Action International (HAI) held a Technical Briefing at the 62nd World Health Assembly, From Education to Regulation: Innovative Tools for the Rational Use of Medicines to present new initiatives aimed at improving public health by addressing the consequences of unethical pharmaceutical promotion. The meeting attracted a range of country delegations, health professionals, civil society organisations, medical and pharmacy students, academics and representatives from the pharmaceutical industry.
Evidence and experiences from regional and global perspectives revealed the urgent need to educate medical and pharmacy students about pharmaceutical promotion before they start prescribing and dispensing. The draft manual Understanding and Responding to Pharmaceutical Promotion: A Practical Guide, produced as part of a collaborative World Health Organization/HAI project, aims to address this need by providing practical training for students to recognise a variety of promotion techniques and to know how to access quality, independent information about medicines.
In an opening address to the meeting, Hans Hogerzeil, Director, Essential Medicines and Pharmaceutical Policies at WHO compared the draft manual to the WHO's Guide to Good Prescribing published in 1994. This landmark initiative trained medical and pharmacy students in evidence-based, patient-centred therapeutics. The new draft manual will act as a companion to this guide.
Session one at the briefing, opened with a presentation from Carlos Berrios, from Farmacéuticos Mundi, Nicaragua and a member of HAI Latin America. He discussed worrying Latin American experiences with pharmaceutical promotion and its impact on public health and health spending. He also showed examples of printed promotional material aimed at health professionals and the public collected in Latin America. The adverts revealed a double-standard in the way medicines are often promoted in Latin America compared with the United States and Europe. Whilst numerous voluntary initiatives are underway in the region to educate students to recognise unethical promotion and understand its consequences, Dr. Berrios made it clear that training on pharmaceutical promotion remains absent in the majority of medical and pharmacy school curricula.
Barbara Mintzes, from the University of British Colombia, Canada, confirmed this training 'gap' in educational curricula with evidence from a study conducted in 2004-2005, the only study of its kind. The study surveyed medical and pharmacy schools, examining how many schools provided training on assessing pharmaceutical promotion and, where present, how much time was dedicated to the training. Results showed that approximately a third of the surveyed medical schools spent only half a day or less on this type of training. Pharmacy schools fared slightly better with more than half of the schools spending more than 10 hours on training students to assess pharmaceutical promotion. In the context of courses that last between four and seven years, this is a disappointingly small amount of time.
In the face of evidence of a training gap, Barbara Mintzes went on to introduce the WHO/HAI draft manual. Understanding and Responding to Pharmaceutical Promotion provides a model curriculum on pharmaceutical promotion and also describes the current imbalance between independent information and promotion. The manual also depicts techniques used by pharmaceutical companies to influence health professionals. The overall aim of the manual is improved therapy and ethical prescribing and dispensing choices that will help health professionals fulfil their responsibility towards patients.
The third speaker, Dee Mangin from the University of Otago, New Zealand presented the methodology of the pilot programme for the manual, starting later this year, and explained the importance of the pilot process in the roll-out of the manual. The pilot studies will evaluate the effectiveness of the manual and enable feedback that will contribute to the structure and content of the final draft. WHO and HAI are also encouraging schools outside the pilot sites to use and evaluate the manual in the coming year. In the discussion following Session One, there were a number of requests from the audience for further information about the manual and the pilot process.
The co-chair of the meeting, Hans Hogerzeil, summed up the project well, reminding participants that the draft manual is much more than a document, it is about teaching and creating a critical mass of people through the multiplying effect of training and knowledge transfer.
Session Two introduced another critical aspect of preventing unethical promotion practices, looking at national regulatory frameworks that govern pharmaceutical promotion. Effective regulation is crucial to preventing unethical promotional activities. However, the first speaker, Carole Piriou from HAI Africa presented studies conducted in five African countries, which revealed that, though most of the involved countries have some form of regulation on pharmaceutical promotion, a lack of enforcement has led to inappropriate adverts aimed at health professionals as well as the public.
After her presentation, Lilia Ziganshina from HAI Global introduced two new projects to assess the effectiveness of national regulations on pharmaceutical promotion and develop a tool to support governments in implementing the WHO Ethical Criteria on Medicinal Promotion. Together, the two projects represent the Initiative Regulation of pharmaceutical promotion: Assessment, Analysis and Advocacy. The initiative will produce a methodology that will promote a robust, standard and comparable means of assessing existing regulatory frameworks, analysing the effect of regulations, identifying gaps and also providing 'model' legislation for adaption in national contexts.
The meeting revealed a groundswell of interest in the problem of unethical pharmaceutical promotion across a range of stakeholders and continents. The need to strengthen education and training for health professionals on how to critically assess pharmaceutical promotion was clearly illustrated in the contributions from all speakers on the panel.
Tim Reed, Director of HAI Global, commented, "We were extremely pleased to have the opportunity at the World Health Assembly to bring together a group of experienced and interested participants to discuss the crucial issue of unethical promotion of medicines and the dangers it presents to public health all over the world. It's clear that a lot needs to be done."
For more information about the manual and plans for pilot testing, please contact the Project Officer, Lisa Hayes, for more information lisa@haiweb.org
To learn more about the Regulation of Pharmaceutical Promotion: Assessment, Analysis and Advocacy initiative, please contact Project Officer, Lilia Ziganshina lilia@haiweb.org