Results from a study published by Dondorp and colleagues (Dondorp et al. 2004) found that samples of artesunate tablets in Laos were ‘counterfeit’ after both chemical testing and package verification. Additionally, this study highlights the use of sophisticated technology to replicate the genuine ‘Guilin Pharma’ hologram on the packaging from falsified artesunate tablets in southern Laos (Dondorp et al. 2004). Another investigation of fake artesunate samples, collected 115 further samples in Laos with a total of 49.9% fake artesunate with either no or insufficient quantities of the Active Pharmaceutical Ingredient (API) (P. Newton et al. 2008). While in a further study, 180 outlets in 12/18 province were surveyed in 2003 to record the presence of oral artesunate monotherapies (oAMTs) (Sengaloundeth et al. 2009). Out of 180 outlets, 25 sold banned oAMTs, and 22 of those were deemed ‘counterfeit’. Although these findings provide vague estimates of the scale of the problem, such evidence may have prompted the FDD and implementing partners to improve efforts against poor- quality medicines in Laos.
The revision of the National Medicines Policy in 2003 formed a window of opportunity to strengthen quality monitoring operations. The revised NMP (2003, Article 2.3) emphasizes first and foremost monitoring on drug safety and efficacy for consumer protection rather than addressing the crime of falsified medicines. The focus of this policy is primarily on quality assurance, stating that ‘Quality assurance is a wide-ranging concept covering all matters that
directly or indirectly influence the quality of a product’ (Article 4). The revised policy states that pharmaceutical products proven unsafe or ineffective will be recalled and that Marketing Authorizations may be withdrawn, if a product are subsequently deemed non-compliant with submitted quality standards or found to be unsafe for consumers. While the Law on Drugs (2000) already called for the establishment of Toxicology Information Centre, the revised NMP strengthens pharmacovigilance procedures. Article 4.5, for example, states that the MoH should use existing international networks for quality assurance such as the Electronic System or Drug Information Exchange in the Western Pacific Region, to share information on drug regulatory decisions in other countries and improve Laos’ efforts in the quality assurance of new drugs. Article 2.10 of the revised NMP also encouraged the government to ‘identify and to promote research activities, which will provide evidence based decisions for interventions for strengthening the implementation of the NMP’. This is testimony once again to a strong focus on evidence-based policy making, with an openness to research and external collaborations. This emphasis is potentially a legacy of the involvement of SIDA and the Karolinska Institute of Stockholm as international collaborators in the drafting of the NMPs (Jönsson et al. 2015).
7.2.2.2 USP and drug quality monitoring activities
To support the implementation of drug quality monitoring activities, USP has provided invaluable technical assistance to the FDD and the BFDI, since it started its operations in Laos in 2003. The USP Promoting the Quality of Medicines (PQM) program proved crucial in strengthening drug quality monitoring operations in Laos. In its role as a main technical partner to the FDD and the BFDI, USP acts as policy entrepreneur along with LOWMRU for efforts against poor-quality AMLs, raising awareness about the risks of poor-quality medicines in the supply chain and harnessing political will to improve quality control of medicines. More specifically, USP supports post-marketing surveillance efforts and the quality inspection of AMLs, for example through the development of laboratory standard operating procedures, as well as a clear testing and sampling methodology. A yearly average of 250 samples in each province are tested on site using the USP-sponsored minilab. All suspect samples are then forwarded to the national laboratory, known as the Food and Drug Quality Control Centre (FDQCC). If no samples are suspect, 10% of the initial sample is forwarded through regardless. USP supports capacity development for the national lab in preparation for a potential international ISO certification for its testing methodology in the future. It also supports laboratory staff in their learning of English to facilitate this process. The PQM program, as an initiative, is present in more than one country throughout the GMS, and not
only supports the capacity of the Lao government to improve their quality monitoring activities, but creates a region-wide network among Mekong countries to share information and expertise on efforts against poor-quality medicines.
As part of the government’s efforts to improve access to quality AMLs, the sale and distribution of oAMTs was banned in 2007. Since 2008, the Public-Private Mix (PPM) program led by the FDD, with technical support from the WHO and funding from the GF, has been a key initiative to improve access to good quality medicines and to exercise some control over the private sector distribution of essential medicines, as suggested by respondents from the CMPE. The first initiative within this PPM program was to map private health facilities and pharmacy outlets in Laos to subsequently invite them to a training course on the use of RDTs for malaria diagnosis and on effective reporting of malaria cases. After this course, private sector outlets were given the option to opt into the PPM scheme with the signature of a yearly contract. Those that agreed to the terms (approximately 250 pharmacies to date) were given permission to distribute first line treatments to confirmed malaria patients. Despite these initiatives, respondents suggested that oAMTs are reportedly still available through unofficial channels (Skerrit et al. 2014).
7.2.2.3 Improving equitable access to quality medicines
Most policy and legal documents in this second phase of the policy process emphasize improving access to medicines, focusing not just on safety and efficacy and consumer protection, but on key issues of equitable access to health services and access to medicines for vulnerable populations. This emphasis is important because it translates into a priority focus on strengthening health systems in support of the principle of universal health coverage. The first NMP (1993) already emphasized the goal of ‘ensuring availability and rational use of high quality medicines at low cost, with a focus on vulnerable populations in remote areas’. Additionally, the overall objective of the revised NMP (2003, Chapter 1) includes ensuring ‘equitable availability and affordability of essential medicines’. Under Article 8.6, the NMP 2003 focuses on ’economic strategies for medicines’ to finance access to essential drugs and encourage cost recovery by harnessing donor financing to provide essential medicines for all, including for remote and vulnerable populations. Furthermore, the Law on Health Care (2005), which details the health insurance system, reiterates the need to: ‘improve the quality of health care to ensure that the whole population and in particular women and children, poor citizens and those who live in remote or isolated areas, have a good state of health’ (Article 5).
Despite an interest in the problem of poor-quality medicines, definitions of poor-quality medicines in rules and regulations drafted between 2003 and 2011 remain vague. The 2003 regulation on import-export companies, for example (Article 14.4), states that the ‘import- export of unqualified drugs, counterfeit drugs, drugs from improper sources, incorrect packaging….and all types of banned drug are prohibited’; hereby using in its definition of poor-quality medicines a wide array of terms from ‘unqualified’ to ‘banned’ vs. ‘prohibited’, none of which are defined further in the document. The term ‘falsified’ still does not appear in this definition.
7.2.3 Phase III: cooperation against substandard medicines (2011-2016)