TREBALLAR I ESTUDIAR EN LA UA

6.2.3.1 Enforcing the ban on oAMTs

In the third phase of the policy development process, the introduction of a Medicines Policy (2010) offered a window of opportunity to align the role of the DDF and the MoH with the Health Strategy Plan (2008-2015) and the National Strategic Plan for Elimination of Malaria (2011-2015). As reported by Yeung et al. (2011), access to quality subsided malaria commodities in remote areas of Cambodia remained poor. In line with such evidence, the Medicines Policy focuses more specifically on the promotion of equitable access to good

34 _{The PV Centre is housed within the DDF, under the Essential Drugs Bureau.} 35 _{A fine of 2-10 million Cambodian Riels instead of 20-50 in the 1996 Royal Kram.}

quality, safe and efficacious medicines and on promoting the rational use of medicines (including AMLs). It also calls for stronger PV efforts by encouraging health workers to report ADRs more systematically, and by strengthening the national laboratory known as the National Health Products Quality Control Centre (NHQC) to reach international standards, calling for a re-organization of its functions. This policy aims to reinforce quality monitoring activities, more specifically, through the enforcement of the ban on oAMTs. The MoH Control Agents, whose authority falls under the Drug Regulation Bureau of the DDF, have a mandate to seize ‘counterfeit medicines’ and ‘other suspicious exhibits’, as stipulated in the (2011) Prakas on Roles and Responsibilities of Control Agent. In 2010, the MoH led a crackdown on unlicensed pharmaceutical outlets to enforce the ban on oAMTs, as well as licensing procedures. This initiative marked a turning point when MoH Control Agents raided several pharmaceutical outlets including informal outlets at the Olympic Market (central market) of Phnom Penh. This initiative led to encouraging results (Yeung et al. 2015), including the reduced circulation of unauthorized oAMTs (some of which were of poor-quality) and the closure of numerous unlicensed outlets predominantly in urban zones. According to various respondents, government actors capitalized on this successful initiative, which also received a lot of attention in the media and from the international community.

In this third phase, USP and PQM programs also continued their support of the DDF’s quality monitoring efforts for AMLs, and supported the enforcement of the ban on oAMTs. As a result of combined sampling and quality testing activities, 22 tons of falsified medicines were seized and destroyed between December 2010 and January 2011 (Fougeres 2011). Despite the support of technical partners, it appears that the focus of the MoH was predominantly on implementing the ban on oAMTs to strive towards malaria elimination in accordance with donor priorities, rather than strengthening post-marketing surveillance activities altogether. In fact, there is no further record in this third phase of concrete initiatives taken by the IMC since the ban on oAMTs. The FSP Mekong (a French government initiative which ended in 2015) did provide funding to facilitate more cross-sectoral cooperation against falsified medicines – but according to respondents’ feedback, this initiative has had limited success beyond the ban on oAMTs. Government officials’ focusing on the success of the 2010 crack down for example, diverted attention to the broader issue of poor-quality AMLs, including the pharmaceutical crime of medicines falsification and the illicit trade in falsified drugs.

6.2.3.2 Malaria elimination and the ban on oAMTs

The focus on the ban and the enforcement of licensing procedures, results suggest, may have been motivated by the desire to ‘contain’ the threat of artemisinin resistance to support malaria elimination efforts. Arguably, the driving principle behind this third phase of the policy process seems to be malaria elimination and efforts against artemisinin resistance. Several donors, such as the Australian Department of Foreign Affairs and Trade (DFAT) and the Bill and Melinda Gates Foundation (BMGF), have provided substantial funding in support of malaria control efforts in Cambodia. As suggested by respondents, the bulk of international aid for health in Cambodia is aimed at malaria control and elimination rather than improving medicine quality per se. Donors’ interests are geared towards addressing the threat of artemisinin resistance, through initiatives such as the region-wide Emergency Response to Artemisinin Resistance (ERAR) led by the WHO or the Global Fund’s Regional Artemisinin- resistance Initiative (RAI). This may explain the government’s focus on the ban on oAMTs, as oAMTs are perceived as directly contributing to artemisinin-resistance.

When discussing the policy process and the key policy actors involved against poor-quality antimalarial medicines in Cambodia, respondents regularly mentioned Village Malaria Workers (VMWs)36 _{as having played an important role in the fight against poor-quality} medicines, by providing information on health seeking behaviour and promoting the rational use of AMLs. ACT watch and Malaria Consortium were also identified as key organizations providing essential data on AML distribution methods. The mandate of these organizations, however, is towards malaria control rather than directly reducing the prevalence of poor- quality antimalarials – although the latter objective can be acknowledged as part of the former. With increasing media attention and sustained donor support for efforts against artemisinin resistance (and therefore against the circulation of unauthorized, poor-quality oAMTs), the government-level representatives emphasize the success of these operations, failing in return to acknowledge the current weaknesses that remain in the drug regulatory system to address the broader threat of poor-quality medicines.

6.2.3.3 Cross-border cooperation

With regards to cross-border cooperation against poor-quality medicines in this third phase, the Medicines Policy (MoH 2010) does demonstrate Cambodia’s willingness to engage with

36 _{VHWs are funded through the United States Agency for International Development (USAID) and} managed by Cap-Malaria (Cap-M) and the National Malaria Program (CNM).

ASEAN-wide harmonization efforts. Since March 2010, applications for medicine registrations are made using the ASEAN ACTD and ACTR forms as part of the harmonization of pharmaceutical regulatory procedures in Southeast Asia. While official intentions to cooperate regionally are clearer within official documents of the Ministry of Commerce (such as the 2000 Law on the Management of Quality and Safety of products and Services), which institutionalizes the exchange of information with regional associations and international agencies, the Medicines Policy calls for the facilitation of regional cooperation and for sharing common procedures and experiences among ASEAN member states. Although a less systematic commitment, it is an important one nevertheless which suggests an intention to address a threat that is inherently regional (the threat of artemisinin resistance).

6.3 Perceptions of the problem of poor-quality AMLs

In this section, I present the findings from 17 stakeholder interviews conducted in 2015 in Phnom Penh, with representatives from the government, members of implementing partner organizations, donor organizations, as well as external consultants to the Cambodian health sector. These findings are summarized in Table 11 on page 120. While most participants seemed open to addressing the topic of medicine regulation and the problem of poor-quality medicines, there remained a notable degree of political sensitivity around the topic among government-level representatives, which many non-government interviewees were quick to warn me about. Some mentioned that this sensitivity might be due to government-linked vested interests in what has been described as a rather opaque procurement process. Due to the political sensitivity, many government officials refused to be interviewed. In some cases, I had to shift the focus of the interviews with some respondents to ‘access to medicines’ as a general topic before addressing the perceived threat of loosely termed ‘poor-quality medicines’, including both falsified and substandard medicines. For the Ministry of Interior representatives (in charge of the inspection of medicines for example), a lengthy bureaucratic process to request an interview made it impossible to interview a representative before the end of my fieldwork. Thus, I was only able to interview two government-level respondents in Cambodia. Due to the difficulty of obtaining open accounts regarding the situation of poor- quality medicines, many more interviews were conducted with implementing partner (IP) organizations and International Organizations (IOs) working with the Cambodian Ministry of Health (MoH), and whose views served to provide additional information on the Cambodian situation.

Frame Description

Medical Government respondents dismiss the challenge of poor-quality AMLs and emphasize the problem of oAMTs for malaria elimination.

Political Non government respondents highlight the lack of transparency in policy processes, the supply chain of pharmaceuticals and quality monitoring efforts, linking the problem of vested interests to the low political commitment to the problem of poor-quality medicines. Regulatory Both categories of respondents refer to the lack of financial and human capacity and poor

cross-sectoral cooperation efforts to regulate pharmaceutical effectively.

Health Systems Non-government respondents explain that the patchy access to health services and the distribution of cocktails of drugs through unqualified pharmacy personnel, are health system challenges that impact access to quality medicines. Patchy access to health services and lack of enforcement of health practitioner licenses.

Security Government respondents describe the problem of poor-quality medicines as a problem coming from the region and posing a national security concern, while both categories of respondents stated that the demand for cheaper accessible treatments among MMPs remains a challenge that requires better cross-border cooperation.

Economic Few references were made to the economic frame, however, respondents expressed concern at the increased flow of illicit goods following the AEC 2015 and discuss the affordability of AML treatments.