by Raffaella Ravinetto (Clinical Sciences Department, ITM Antwerp) and Christophe Luyckx (Public Health Department, ITM Antwerp)
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The universal availability of essential quality medicines (1), at affordable prices and with appropriate quality standards, is a fundamental prerequisite to ensure universal access to health.
In the field of prices of essential medicines, a lot has been done in the last decade for avoiding that the enforcement of inadequate intellectual property rules in the pharmaceutical field kept new medicines out of the reach of people living in middle- and low-income countries (2). Even if much more must be done to make all the essential medicines available to all those who are in need, India has set -with its Patent Act of 2005 (3)- a valuable model for maintaining the primacy of public health over commercial interests. Importantly, the lessons learned in the field of HIV/AIDS to increase the affordability of quality-assured essential antiretrovirals (4) seem now to start to serve as an example in other therapeutic fields: for instance, legitimate exceptions to patent-monopoly, like compulsory licenses, are now used to increase the access to appropriate anti-cancer medicines for those in need (5).
However, the gap between high-income countries vs. middle- and low-income countries is still outstanding in what concerns the assurance of appropriate quality standards for all essential medicines (6). The World Health Assembly (WHA) has been discussing for many years the challenge to individual and public health represented by poor-quality medicines, without reaching an agreement on measures to be implemented to fight them. Only in 2012, the 65th WHA approved a resolution to create a new ‘Member State mechanism’ (i.e. an intergovernmental mechanism, open to all WHO Member States), proposing international collaboration on ‘substandard, spurious, falsely-labelled, falsified or counterfeit (SSFFC) medical products’ (7). Its explicit goal is ‘to promote the prevention and control of SSFFC medical products and associated activities, to protect public health and promote access to affordable, safe, efficacious and quality medical products’. Noteworthy, the definition of “SSFFC medical products” is quite comprehensive: in fact, it encompasses medicines, vaccines, medical devices and in vitro diagnostic tests. Also, this definition does not prioritize counterfeits (products whose identity has deliberately and fraudulently hidden) (8) over substandards (legitimate, authorized products that do not comply with appropriate quality standards) (9). In fact, sub-standards are at least as dangerous as counterfeits, because their effects are often life-threatening or fatal, due to either direct toxicity or lack of efficacy. In addition, substandards are often the result of structural negligence, and structural negligence in pharmaceutical production should never be considered less important than a deliberate or fraudulent action, because the consequences are equally serious for the final user (10). As we already reminded elsewhere (11), the creation of the Member Mechanism offers a precious opportunity to tackle this problem in a comprehensive, patient-centered approach, aimed in first place at protecting individual and public health from the effects of ineffective or contaminated medicinal products, which are mainly prevalent in resource-poor countries. To do so, the Member State mechanism should prioritize activities that:
– Promote preventive measures, aimed at avoiding that poor-quality medical products reach the patients, rather than identifying them a posteriori, when a significant harm may have already been done, as it happened in recent cases in Bangladesh (12), Panama (13), Pakistan (14), and as showed by many retrospective surveys conducted on antimalarials (15, 16);
– Promote measures that may help to eliminate poor-quality medical products as a whole, rather than concentrating on counterfeits only. Even if there may be commercial interests to do so, a counterfeits-focused approach is market-centered rather than patient-centered, and it leaves many neglected patients exposed to the risk of being treated with substandard medicines.
– Strengthen the national and international regulation, with special focus on initiatives that promote collaboration, knowledge-sharing, resource-sharing and networking among national medicines regulatory authorizes, as described in a recent, very interesting concept paper by the WHO Pre-qualification programme (17);
– Reinforce the current WHO Pre-qualification programme (18) and possibly expand it to more therapeutic fields in addition to HIV/AIDS, malaria, tuberculosis and reproductive health.
– Educate and sensitize the main public and private stakeholders to adopt and implement procurement practices for medicines and other medical products based on stringent quality assurance criteria, in order to avoid risks for the patients and to promote the economical sustainability of quality production.
We hope that the Member State mechanism, which met for the first time in Buenos Aires in November 2012, will manage to overcome all the ideological, economical and commercial interests that could hamper its work, and that it will promote effective and patient-centered measures to ensure universal access to medicines of ensured quality. Just as States have a duty to ensure access to essential medicines for all, they should also ensure the same level of quality assurance and protection from ineffective or toxic medical products to everyone, irrespectively of the income level of the individuals, households and countries. Access to medicines and quality of medicines should be universal, and they should always go together, everywhere and for everyone.
Bibliography and websites
3 – Lancet Special Report. India’s patent laws under pressure. Vol 380 September 15, 2012. http://www.thelancet.com/
4 – MSF Access Campaign. Untangling the web of antiretroviral price reduction. 15th Edition. July 2012. Available at http://utw.msfaccess.org/
5 – Arie S. Bayer challenges India’s first compulsory licence for generic version of cancer drug BMJ2012;345:e6015
6 – Caudron J-M, Ford N, Henkens M, Mace C, Kiddle-Monroe R & Pinel J (2008) Substandard medicines in resource-poor settings: a problem that can no longer be ignored. Tropical Medicine and International Health 13, 1062–1072
8 – WHO Fact sheet N°275; http://www.who.int/mediacentre/factsheets/fs275/en/
9 – WHO frequently asked questions. What are substandard medicines? Available athttp://www.who.int/medicines/services/counterfeit/faqs/06/en/index.html
10 – Dorlo TPC, Ravinetto RM, Beijnen JH, Boelaert M. Commentary: Substandard medicines are the priority for neglected tropical diseases. BMJ 2012;345:e7518
11 – Ravinetto R, Boelaert M, Jacobs J, Pouget C, Luyckx C. Editorial. Poor-quality medical products: time to address substandards, not only counterfeits. Tropical Medicine and International Health 2012. doi:10.1111/j.1365-3156.2012.03076.x
12 – Dorlo TPC, Eggelte TA, Schoone GJ, de Vries PJ, Beijnen JH (2012) A Poor-Quality Generic Drug for the Treatment of Visceral Leishmaniasis: A Case Report and Appeal. PLoS Negl Trop Dis 6(5): e1544. doi:10.1371/journal.pntd.0001544
13 – E Danielle Rentz et al., Outbreak of acute renal failure in Panama in 2006: a case-control study. Bulletin of the World Health Organization 2008; 86: 749-756. Available at WHO website
14 – Arie S. Contaminated drugs are held responsible for 120 deaths in Pakistan. BMJ 2012;344:e951 doi: 10.1136/bmj.e951
15 – C. Maponga and C. Ondari, The quality of antimalarials. A study in selected African countries. WHO/EDM/PAR/2003.4, May 2003. Available at: http://apps.who.int/medicinedocs/en/d/Js4901e/
16 Survey of the quality of selected antimalarial medicines circulating in six countries of sub-Saharan Africa. WHO (Quality Assurance and Safety of Medicines, Department of Essential Medicines and Pharmaceutical Policies), January 2011. Available at:www.who.int/medicines/publications/WHO_QAMSA_report.pdf
17 – Regulator prequalification of medicines: a future concept for networking. WHO Drug Information Vol. 26, No. 3, 2012
Raffaella Ravinetto holds a Pharmacy Degree from the University of Torino and a Postgraduate Diploma in Tropical Medicine from the Antwerp Institute of Tropical Medicine. After a seven-year experience as a Clinical Research Scientist in the private pharmaceutical sector, she worked in emergency and development programs in the Balkans and in Africa. In 2002, she joined Médecins Sans Frontières (MSF), where she followed various dossiers on access to essential medicines and quality of medicines, while performing regular field assessments. She currently works at the Antwerp Institute of Tropical Medicine, as head of the Clinical Trials Unit, coordinator of the Switching the Poles Clinical Research Network and promoter of Quamed (a Network promoting evidence-based strategies for universal access to quality medicines). She was president of the Italian branch of MSF (2007-2011). Her main areas of interest include North-South collaborative clinical research, research ethics (particularly in relation to resource-constrained settings) and access to health.
After 8 years experience in the field of pharmaceutical marketing and communication, Christophe Luyckx joined the humanitarian sector where he implemented social marketing programs for various NGOs, donors and consultancy offices, aimed at strengthening the impact of generic medicines in developing countries. Christophe has also served as CEO of PSF (Pharmaciens sans Frontières) and PAH (Pharmacie et Aide Humanitaire) and was Marketing Director of an important procurement agency for generic medicines where he developed the procurement channels from China and India. These various assignments and experience in over 20 countries led Christophe to identify the quality of medicines as a major concern for developing countries and encouraged him to join the Institute of Tropical Medicine of Antwerp where he currently coordinates QUAMED: “quality medicines for all.” Christophe holds a master’s degree in Social Communications and a University degree in Public Health and Health Promotion.
This post was crossposted from the Equilibri website.