E-DRUG: WHO concept paper: African Medicine Regulatory Harmonization Initiative
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Dear Colleagues,
We would like to share with you the contribution that we have sent to WHO
concerning the interesting concept paper on the African Medicine Regulatory
Harmonization Initiative. The concept paper is available in the WHO Drug
Information Vol.22, N. 3, 2008, pp. 182-190:
http://www.who.int/medicines/publications/druginformation/issues/DrugInfo08vol22_3/en/index.html [repair link]
Dear Dr. Azatyan,
We are a group of pharmacists who have worked or are still working in
different pharmaceutical projects in and for resource-constrained settings,
mainly in sub-Saharan Africa. We wish to thank WHO for this precious
opportunity to give inputs, based on our professional experience, on the
concept paper on the African Medicine Regulatory Harmonization Initiative.
1.General comments
The WHO Pre-qualification for medicines for HIV/AIDS, malaria and
tuberculosis (which later expanded its field of activities, by including for instance medicines for sexual and reproductive health and for avian flu), represents a very positive move toward the enforcement of the principle that quality and safety standards should be universal. The AMRHI could go even further in this line, by trying to assure universal standards, not on a disease-by-disease basis, but for all essential medicines.
In our experience, the harmonization of the rules and regulations, the
regional and sub-regional collaborations, the possibility of fast track
registration through the recognition of the work of competent (stringent)
authorities and bodies, and the sharing of the results of evaluations and
technical audits, constitute the only realistic way to achieve an effective
control of the quality of pharmaceutical products manufactured, imported and distributed in resource-poor settings. Therefore, we welcome this concept paper, its accurateness in analyzing the problems and its approach to address them, and we welcome the WHO willingness to take the lead in this initiative.
Concerning the two possible scenarios proposed for setting up and
implementing the AMRHI, we definitively favour the second one (where the
WHO-Geneva takes a leading role), which in our opinion has better chances to achieve a significant improvement in quality standards and to maintain it in a sustainable way, through structural changes which should comprise a real shift in the mentality of the concerned policy and decision makers.
Some other elements that in our opinion could be considered when discussing
improvement of the quality of pharmaceutical products distributed in
resource-poor contexts, are the following:
* It is proposed that the initial focus of AMRHI should be on generic
applications. While we agree on this priority, we suggest that AMRHI could
also act as a facilitator for African DRAs, so that they can get scientific
advice from stringent bodies (e.g. EMEA through Article 58) or from qualified experts, before deciding on registration of those innovator medicines that are submitted for registration in resource-constrained countries only (mainly in the field of tropical/neglected diseases).
* In many countries, the National Procurement Centre plays, through the
tenders, a major role in shaping the level of quality standards of medicines entering the public health sector. Thus, the National Procurement Centres should be included among the stakeholders of AMHRI, and the enforcement of appropriate procurement and tendering policies (prioritizing quality over price) could be included among its objectives.
* In many countries, some international organisations are active and
contribute to framing pharmaceutical procurement policies, and they could be included among the stakeholders of AMHRI.
* The protectionism in favour of the local pharmaceutical industry, or toward the industry of countries with privileged bilateral relations, may be understandable from a political and commercial point of view, but it may, in some cases, push medicines of unverified or insufficient quality on the national market. These polices should only be implemented when the quality of the concerned products has been fully ensured, so as to avoid unnecessary risks for the patients.
* Harmonisation of regulation should also be clearly applicable to donations of pharmaceuticals, and participating countries should commit not to let the regulatory system be bypassed under "donation exceptions". Urgent humanitarian donations carried out in case of natural disasters should be under the supervision of a competent body, too, which should be enough efficient as to ensure a timely response to the needs.
* Concerning the regional stakeholders meetings, we feel that local industry associations and importers/wholesalers of medicines, being part of the system which is subject to the regulatory evaluation, should participate with a status of "observers".
* Corruption can often have a negative impact on the enforcement of
appropriate policies, and it should be appropriately fought, including by
maximizing transparency and accountability.
2. The price of medicines
A crucial point is mentioned in the chapter on "political commitment": the
lack of financial accessibility to essential medicines for individuals and
households in resource-poor contexts. Having personally witnessed that the
removal of user-fees can dramatically improve the access to medicines and to health, we would like to link the strategy of AMRHI to the broader framework of the WHO Strategy for Essential Medicines, where the "financial
accessibility to quality essential medicines" should be a major axis.
In this respect, we would like to note that the price of essential medicines, which is influenced by a number of elements including unnecessary steps in the distribution chain, already constitutes a barrier to access for the poor.
Thus, even if the implementation of appropriate quality assurance measures
could temporarily cause an increase in the average price of medicines, this
would not in itself decrease access to essential medicines, just because it
is ... already decreased, and poor people are already pushed to (dangerously) look for essential medicines on the black market. Thus, these price-related fears should not discourage the upgrade of the pharmaceutical quality system, while we should probably better look at concomitant ways to avoid unnecessary price increases, e.g. along the distribution channels.
Beyond the mandate of AMRHI, there is a moral imperative to ensure the right of the poor to receive quality essential and life-saving medicines for free, just as it happens in rich countries through social solidarity mechanisms.
Because of its unique mandate, we think that WHO is in a privileged position to mobilize policy makers and donors to achieve this goal, through strong political commitment, and through appropriate policies including subsidization and sustainable funding for quality medicines.
3. Evaluation of the efficacy of the strategy
Given the nature of the mandate of AMRHI, we would like to suggest that
qualitative, rather than quantitative indicators were identified to assess
the efficacy of the overall strategy, as well as independent evaluation
mechanisms, based on objective quality indicators.
Many thanks again for this opportunity to comment on the concept paper.
Raffaella Ravinetto, Institute of Tropical Medicine, Antwerp
Jacques Pinel, pharmacist
Jean-Michel Caudron, pharmacist
Sandrine Cloez, pharmacist
Cécile Macé, pharmacist
Daniel Vandenbergh, pharmacist
http://pharmahook.blogspot.com/
rravinetto@itg.be