REMUNERACIÓN DE CARGO DEL FONDO

Driven by socioeconomic developments in the country since the 1990s, Laos undertook a process of reforming its health sector (Kongsap et al. 2014) with the support of international development partners. Simultaneously, there were continuous efforts to strengthen the drug regulatory system to improve access to quality medicines between 1993 to 2003. This included the development of rules and regulations for the registration of pharmaceuticals and the licensing of pharmaceutical manufacturers, importers and distributors. Before the National Medicines Policy was in place, the delivery of drugs to pharmacies was a challenge and there were reports of mismanagement of donated pharmaceutical stocks that expired before reaching patients, or that failed to reach the right patients altogether (Jönsson et al. 2015; Thomé & Pholsena 2009). Loosely regulated private pharmacy outlets proliferated following the switch to an open market economy in the late 1980s, which led to the smuggling of many pharmaceutical products (STK25). These challenges drove support for drafting a National Medicine Policy (NMP 1993). This was drafted and approved in 1993, with the help of the Swedish International Development Cooperation Agency (SIDA) as the main implementing partner in this first phase of the policy process. The NMP was aimed at guiding the general development of a young health and pharmaceutical sector.

7.2.1.2 LOWMRU and the role of evidence

As a key focusing event of this phase, the Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit (LOWMRU) was established in 2000. Professor Paul Newton at LOWMRU first officially reported the presence of poor-quality AMLs in Laos, and the public health danger this represents in 2001, in a study on the quality of artesunate samples from shops, pharmacies and hospitals in five countries across Southeast Asia (Newton et al. 2001). While a relatively small sample of eight tablets was collected in Laos, 38% of those were deemed ‘fake’. This was the first reported evidence of poor-quality antimalarial medicines (AMLs) in Laos available in academic literature. LOWMRU continues to gather evidence on medicine quality in Laos, evidence that serves as guidance for policy makers and legislators. Subsequent publications by the research unit alerted to the urgency of cross-border action to prevent the spread of artemisinin resistance, potentially exacerbated by the availability of poor-quality AMLs. The work of LOWMRU also served to uncover the source and smuggling routes of at least some poor-quality AMLs and raise attention among donor organizations, attracting funding and support from the development sector.

In Laos, LOWMRU benefits from a close working relationship with several state-level actors including the FDD. As a research unit, LOWMRU brings together a network of actors through knowledge sharing. In its capacity to raise awareness about this challenge and gather political support for action to improve access to quality medicines, LOWMRU acts as a policy entrepreneur. The work of LOWMRU triggered a phase of issue and interest formation in Laos by 2003. With regards to sharing knowledge and expertise to strengthen drug regulation, however, Jönsson et al. (2015) note that since the mid-1990s, Thailand and Laos set up a bilateral health sector cooperation committee to learn from Thai expertise in strengthening health systems. From early on, Laos has been open to using scientific evidence to guide policy reforms and to sharing technical knowledge with neighbouring countries in support of efforts to strengthen the health sector. While it is uncertain to what extent scientific evidence influenced policy developments, there may be a link between the evidence produced by LOWMRU and the increasing attention from the Lao government towards the policy problem of poor-quality medicines.

7.2.1.3 Poor-quality medicines defined as counterfeit or unregistered

The Law on Drugs and Medical Products was introduced in 2000 and outlined more specifically the principles of drug management. Additionally, the (2003) Regulation Governing Drug Registration no. 1441/MoH (2003) provides more detail on registration procedures for pharmaceutical products in Laos. Regardless, poor-quality medicines were still defined predominantly as ‘counterfeit’ or ‘unregistered’ medicines. At the outset, the definition of what constitutes a poor-quality pharmaceutical product in Lao laws and regulations, remains unclear due to the inconsistent use of a variety of keywords related to medicine quality since 1993. The main term used in the definition of poor-quality medicines in the NMP was ‘counterfeit’ – a choice of terms that inadvertently emphasized the trade infringement aspect of the problem over its health implications. This may have been a deliberate choice, although the data collected does not suggest a strong inclination towards the protection of intellectual property rights for pharmaceutical products. More likely, the choice of term echoes the preferred terminology used in global communications around the problem of poor-quality medicines in the early 2000s.

The definition of poor-quality medicines available in the Law on Drugs and the Regulation no. 1441, still refers to a ‘counterfeit drug’ as an ‘imitation of a drug product, which is produced, distributed and legally registered’. Regulation no. 1441 (section 6, article 17) also states that ‘it is prohibited for individual and juristic persons to counterfeit the registered drug

formulas, trade names or generic name’. This clause exclusively refers to drug counterfeiting and trademark infringement. These last two definitions not only focus on drug counterfeit but speak of imitations of registered drugs only, thereby omitting from the scope of these laws any falsified medicine circulating in the country whose original brand is not registered in Laos. Penalties were established against individuals who produce or sell counterfeit or unregistered medicines. Regulation no. 1441 (2003), for example, establishes incremental levels of penalties for violations of regulations concerning pharmaceutical management. Any individual who sells ‘counterfeit’ or ‘unregistered’ medicines will see all drugs confiscated after a first violation, receive an additional fine as well as confiscation on second offence, and will be fined at 200% of the total value of all drugs in stock on third offence, with permanent closure of premises. Additionally, the Provision on the Establishment of Drug and Medical Equipment Import-export Companies (1442/MoH 2003) establishes measures against importers of such medicines.

7.2.2 Phase II: Interest formation and quality monitoring (2003-2011)