E-DRUG: Indian substandard products in Africa (10)
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[I would suggest we change the title now to "substandard products in developing countries", unless some Indian E-druggers still have specific comments about the export situation from India? WB]
Dear e-druggers,
We welcome the initiative to start this debate on substandard medicines, which represent a major public health problem in all countries with insufficient enforcement of pharmaceutical regulation. It is positive that awareness around this topic, which is broader and more complex than medicines' counterfeiting, is growing. FYI, we published recently an editorial in the Tropical Medicine and International Health about substandard medicines that can be found here:
http://onlinelibrary.wiley.com/doi/10.1111/j.1365-3156.2012.03076.x/abstract
We would like to add a few comments and inputs on the ongoing discussion:
1. Poor-quality medical products (either substandards or counterfeits) may cause an elevated and avoidable morbidity and mortality if they reach the final user. It is therefore essential to adopt everywhere procurement policies that PREVENT poor-quality products from reaching the patients, rather than just identifying them a posteriori through random quality controls on the field.
2. In the long-term, this should be achieved by strengthening the regulatory oversight in all countries as well as on the international market. However, relying solely on the National Drugs Authorities to guarantee the quality of medicines in low and middle income countries may be insufficient in the short term. In fact, according to the WHO only 20% of the member states have DRAs with "developed capacities", while the remaining have still "variable to limited" capacity, often due to the limited human, financial and technical means. In addition, their capability to control the quality of the medicines that enter their territory or are produced in it is further limited by the global context, which is increasingly "business driven" and unregulated.
3. Many medical organizations (NGOs, public and humanitarian procurement centers, etc.) do have a real possibility to influence the market because they purchase important quantities of medicines and other medical products. If these organizations decide to purchase only products complying with appropriate quality standards, their suppliers will adapt standards accordingly and increase the quality of the products on offer. The Global Fund, having adopted a stringent procurement policy based on the principles of the WHO Pre-qualification, has already played an essential role to push the market of HIV, malaria and tuberculosis toward better standards, at least in the public sector.
4. Getting reliable and unbiased information on the quality of medical products available in the international market is complex, time consuming and expensive. Hence, little information is shared: organizations that wish to assess a wholesaler or a manufacturer do rarely have access to the data already collected by a peer organization. On the other side of the fence, a supplier may be audited tens of times a year for the same purposes, with different quality standards and by different organizations. How could we expect suppliers to act coherently if "we" are not capable to do it ourselves?
5. Information-sharing among peer-organizations that adopt the same referentials [references? Moderator] would avoid duplication of efforts and would push the suppliers operating in insufficiently regulated contexts toward better standards. It is indeed essential that the purchasers of medicines and other medical products make informed decisions about the quality of their purchases based on reliable information, but also that the suppliers know that the purchasers are sharing the information on their quality system: this will result in a strong pressure to upgrade quality standards.
6. We should never forget that most suppliers are profit-driven entities: it is not surprising that, rather than "self-regulating", they often adapt their offer to their customers' requirements. If a customer requires the cheapest medicine available and have no stringent quality requirements, the odds to get substandard medicines will be higher. In addition, a supplier will only invest in improving quality if the investment will bring business. Thus, a common voice with similar requirements coming from several organizations as well as DRAs will undoubtedly have an impact that would not be achievable if each of those organizations would act on its own.
To quote the Belgian motto, the country where our program www.quamed.org is located (and although our country does not currently show a good example of it ;-): "L'union fait la force", which could roughly be translated into "Unity brings strength"
Best regards,
Christophe Luyckx - QUAMED Coordinator
Institute of Tropical Medicine | Nationalestraat, 155 | 2000 Antwerpen Belgium
email: cluyckx@itg.be
cell: +32 473 65 52 09
office +32 3 247 65 95
fax: +32 3 247 65 32
web: www.quamed.org | www.itg.be
Raffaella Ravinetto - Head of the Clinical Trials Unit - Chair of the Quamed Steering Committee
Institute of Tropical Medicine | Nationalestraat, 155 | 2000 Antwerpen
email: rravinetto@itg.be
office +32 3 247 66 25
fax: +32 3 247 66 47
web: www.quamed.org | www.itg.be