VISIBILITZACIÓ I SENSIBILITZACIÓ

This second phase starts with a network configuration change and the establishment of the Inter-Ministerial Committee to Fight against Counterfeit and Substandard Medicines (IMC) in 2005. Further evidence emerged in 2003 and 2006 confirming that poor-quality antimalarials were still a problem in Cambodia. Lon and colleagues (2006) reported that 57.9%

33 _{The GPHF minilab: Developed by the Global Pharma Health Fund E.V., the minilab was designed to} provide all the basic testing tools of a laboratory in one suitcase. It is used to test the quality of medicine samples in resource-constrained and remote areas, where laboratory access is limited.

of antimalarial tablets surveyed from licensed outlets and 75.2% from unlicensed outlets were found to be of poor-quality, with products labelled as being from Thailand, China, Cambodia and Vietnam, amongst others. The IMC was established as a coordination hub for the exchange of information across ten ministries for targeted efforts against poor-quality medicines (see Figure 10 page 113 for a visual representation of the committee membership). It was intended to serve as a platform to raise awareness across departments about this threat and facilitates the cooperation of health control agents, police and customs officials in fighting against the trade of poor-quality and unauthorized pharmaceuticals. Respondents suggest that the Ministry of Economy and Finance (MoEF) has a strong influence in this coalition, due to the power that it holds over approving the budget of the MoH. Aside from the MoH and the MoEF, the Ministry of Justice (MoJ) plays an important role in harnessing support against ‘counterfeit’ medicines through the IMC, as it oversees criminal law against pharmaceutical crimes. There is no evidence in this study of any such penalties being implemented, however. The Ministry of Interior (MoI) within the IMC, coordinates the involvement of customs and police officials in the fight against poor-quality medicines in general. The IMC represents an important network configuration change to trigger regulatory responses against poor-quality medicines. The establishment of the IMC evidences that by 2005, the problem of poor-quality medicines had reached the policy agenda in Cambodia.

Figure 11 Legend for Map of Stakeholders

*The landscape of policy actors represented above is an attempt to visually represent complex and dynamic interactions between several actors, whose professional links are not limited to those represented here. These interactions change over time and this map only captures a snapshot in time to support the reader’s understanding of the position of the IMC.

6.2.2.2 A focus on artemisinin resistance and oAMTs

Following the establishment of the IMC, the main focusing event in line with this second phase has been the increasing evidence of artemisinin resistance at the Thai-Cambodian border. This marked a phase of capacity building for efforts against substandard medicines in particular, by streamlining the distribution of ACTs and reducing access to banned oAMTs. The Good Pharmacy Practices Guide (2006), for example, has a specific section on AMLs, specifying that the sale of oAMTs is prohibited, that diagnostics should be performed first, and that serious cases should be referred to closest public health service. This provides instructions on the sale of pharmaceutical products from labelling instructions to adequate warehousing and storage facilities. It also discusses how to deal with ‘spurious’ or ‘expired’ medicines – to be kept separately for destruction. It does not, however, define what constitutes a ‘spurious’ medicine. By 2007, the WHO had banned the use and production of oAMTs and the Cambodian government followed suit in 2008, by officially banning the use, production and sale of oAMTs in Cambodia.

6.2.2.3 Revised legal framework for pharmacovigilance

Fears regarding the spread of artemisinin resistance and the ban on oAMTs coincided with a second window for pharmaceutical policy change and the introduction of the 2007 Amendment to the 1996 Law. The problem of poor-quality medicines was first mentioned in the Law on Management of Pharmaceuticals (1996). Article 12 of this law defined the scope of a penalty for medicines that are ‘counterfeit’ or of ‘non-quality’, as well as for ‘expired’ or ‘unauthorized’ medicines. Here, the definition of poor-quality medicines revolved predominantly around trademark infringement and non-registration. The falsification of pharmaceutical products was addressed exclusively as a commercial fraud (for example in the Law on the Management of Quality and Safety of Products and Services (2000)) or as a trademark infringement, rather than a crime. The 2007 Amendment clarifies the definition of a ‘counterfeit’ medicine (Article 2.2), but alludes first and foremost to the substandard nature of the product with a dose of Active Pharmaceutical Ingredient (API) below the required threshold for drug efficacy. This definition does not encompass the notion of ‘intent’, which would qualify a poor-quality medicine as ‘falsified’. Once again, there is an amalgam of definitions between substandard, unregistered/unauthorized/expired, as well as counterfeit medicines. More specifically, the 2007 Amendment emphasizes the importance of addressing Adverse Drug Reactions (ADR) and improving pharmacovigilance (PV), in line with fears of rising resistance. The Amendment granted the MoH a mandate to recall batches in case of

reported ADR. The recall procedure does not refer to terminology of ‘falsified’ medicines but discusses pharmaceutical products that are ‘dangerous to health’. This suggests an emphasis on monitoring ADR rather than addressing the threat of pharmaceutical crime. The Good Pharmacy Practices Guide (2006) highlights the role of pharmaceutical outlets in ADR reporting and product recall. In parallel to this renewed emphasis on PV activities, in 2008 the Cambodian PV centre was established34 _{with a Medicines Safety Advisory Committee.} Despite the establishment of a PV centre, the electronic reporting database and national pharmacovigilance guidelines were only introduced in 2012 and ADR reporting still remains low – at 3% in 2011 (Nwokike et al. 2013).

The 2007 Amendment also introduced changes regarding the penalties incurred for the import, distribution or sale of poor-quality medicines, which suggests a more conciliatory response to such unlawful activities. The 2007 Amendment outlines penalties for the production, import, export, and trade of ‘counterfeit drugs’, as well as pharmaceuticals of ‘non-quality’ (at Article 12), and imposes a lower fine35 _{than stipulated in the 1996 Royal Kram. Furthermore, the 2007} Amendment reduces the severity of the punishment for accomplices to an ‘administrative penalty’ instead of a fine (at Article 13). These revisions deter efforts towards a more transparent inspection process and suggest limited political will to penalise activity around counterfeit or non-quality drugs. Instead, the focus of policy efforts appeared to be on containing the threat of artemisinin resistance and enforcing the 2008 ban on oAMTs. The focus shifted away from poor-quality medicines as a pharmaceutical crime towards the challenge of substandard and unregistered medicines (oAMTs in particular), and the risks that these pose for the spread of artemisinin resistant malaria.

6.2.3 Phase III: Strengthening post-marketing surveillance against oAMTs (2010-