Transparent Policy to Provide Safe and Affordable Medicines for All (LK0002)

Essential medical drugs play an important role in preventive, promotive, curative and rehabilitative health care. Sri Lanka is proud to sustain a free and universal healthcare system, which has helped it score high on health indicators for the country (such as life expectancy and utilization of health services). However, there still exist disparities in implementation of this system. Even if medical care is free, if safe and affordable medical drugs are not available to the general public, it will affect people’s health in a significantly negative way. In Sri Lanka, non-availability and shortage of drugs in government hospitals and clinics are having disastrous consequences. The quality and cost of drugs is also a serious problem for the people. This commitment aims to improve national health standards and ensure safe and affordable medicines will be available to all. The appointment of an advisory board to the National Medicinal Drug Regulatory Authority (NMDRA) and collaboration in assessing implementation will also increase government accountability and transparency. Issues to be Addressed: At the present there is no oversight from civil society of the national health standards and their implementation. There have been many cases of significant price fluctuations, poor quality drugs and non-availability of medication. This policy will address these issues by guaranteeing public oversight of the availability of safe and affordable medications through an advisory board to the National Medicinal Drug Regulatory Authority (NMDRA). Main Objective: Increase the level of availability and affordability of quality essential medicines in the country.

2. Safe and Affordable Medicines

Commitment Text:

Transparent Policy to Provide Safe and Affordable Medicines for All

Essential medical drugs play an important role in preventive, promotive, curative and rehabilitative health care. Sri Lanka is proud to sustain a free and universal healthcare system, which has helped it score high on health indicators for the country (such as life expectancy and utilisation of health services). However, there still exist disparities in implementation of this system. Even if medical care is free, if safe and affordable medical drugs are not available to the general public, it will affect people’s health in a significantly negative way.

In Sri Lanka, non-availability and shortage of drugs in government hospitals and clinics are having disastrous consequences. The quality and cost of drugs is also a serious problem for the people. This commitment aims to improve national health standards and ensure safe and affordable medicines will be available to all. The appointment of an advisory board to the National Medicinal Drug Regulatory Authority (NMRA) and collaboration in assessing implementation will also increase government accountability and transparency.

Milestones:

• 1 Appointment of the advisory board to the National Medicinal Drug Regulatory Authority (NMDRA) with representation from CSOs/Health Activists.
• 2 Establish an institutionalized monitoring system to ensure essential drug availability (RMSD, Institution level) with provision for public feedback.
• 3 All government hospitals and clinics ensure provision of quality essential medicines at all times and ensure public dissemination of the information through display boards.
• 4 Establish a rating system for private pharmacies that will be based on availability of essential medicines at affordable pricing and make that information public through a web portal.
• 5 Public awareness on the rating system for private pharmacies based on availability of essential medicines at an affordable price.

Responsible institution: Ministry of Health, Nutrition and Indigenous Medicine

Supporting institutions: National Medicines Regulatory Authority; Medical Supplies Division, Sarvodaya, Patient’s Rights Movement, People’s Health Movement (civil society)

Start date: July 2016............    End date: July 2018

Editorial Note: The text of the commitment was abridged for formatting reasons. For full text of the commitment, see the Sri Lanka National Action Plan 2016–2018 at http://bit.ly/2wv3jXR.

Commitment Aim:

This commitment aimed to increase the availability and affordability of quality essential medicine across Sri Lanka. The Ministry of Health and other associated stakeholders anticipated that this will lead to improvements in health indicators and national health standards. Although the milestones indicate a commitment to greater transparency in the availability of safe and affordable medicines, the commitment does not explicitly propose to establish a ‘transparent policy’ to ensure the same.

Status

Midterm: Limited

This commitment achieved limited completion by the midterm. The National Medicines Regulatory Authority (NMRA) nominated a list of candidates to comprise the advisory board, but noted that it was the responsibility of the Minister of Health to convert these nominations into formal appointments (Milestone 2.1). [22] The nominations included members of civil society, in line with guidelines on the board’s composition and representation. [23]

There was no fully operational, institutionalised monitoring mechanism, with provision for public feedback, on the availability of essential medicine (Milestone 2.2). This was confirmed by Sarvodaya, a civil society organisation advocating better health service delivery. [24] However, the NMRA stated that the Medical Supplies Division (MSD) under the Ministry of Health was developing basic online infrastructure to track stocks of medicine and supplies at the national, regional, and local level. [25]

The ministry noted that a number of health clinics and hospitals had started presenting information about the availability of quality essential medicines at public-facing locations (Milestone 2.3). However, this was not taking place in a uniform or systematic manner. [26] The pharmacy rating system was also not in place by the midterm (Milestone 2.4). A representative from the NMRA reported that they developed guidelines that could eventually inform such a rating system. [27] A civil society representative from Sarvodaya added that no specific lobbying had been undertaken by civil society in this regard. [28]

End of term: Limited

The commitment’s end-of-term completion remained limited.

Milestone 2.1: The Minister of Health had not finalized the appointment of the advisory board to the NMRA at the time of writing. The Ministry of Health speculated that key decision-makers were buoyed by the consistent reduction of prices of essential medicines. ^[29] Thus, they did not consider the appointment of an advisory board a matter of urgent concern.

Milestone 2.2: The MSD implemented a monitoring mechanism [30] to ensure the availability of medicine up to the level of Regional Medical Supply Divisions (RMSDs). The decentralized RMSDs distribute medicine, purchased centrally by the MSD, to 960 primary health care institutions across the country. There is, however, no monitoring of drug availability at the more granular institutional level. ^[31] Although a positive start, the RMSD monitoring mechanism [32] is currently not open for public feedback. ^[33] The ministry confirmed that it was soliciting external support to introduce a system to effectively monitor medicine stocks at all levels. ^[34]

Milestone 2.3: Civil society anticipated that this commitment would lead to health institutions proactively, and publicly, displaying the availability of medicine. [35] Although only a marginal increase from the midterm, civil society confirmed that such publication, though not thorough or systematic, had commenced at a small number of health clinics and hospitals. [36] However, as neither civil society nor government could provide a precise, verifiable figure, there is no change in the completion of this commitment.

The Ministry of Health explained that doctors only prescribed medicines that were available at the hospital dispensary. These medicines were available free-of-charge. If an essential medicine was unavailable on a particular day, the doctor would prescribe a suitable alternative. Given this protocol and the availability of essential medicines, the ministry suggested that the public display of available medicines was not of utmost concern. ^[37]

The milestone also refers to essential medicines being of adequate quality. The Ministry of Health confirmed that several measures are consistently taken to ensure that medicines of adequate quality are circulated through the system. ^[38] These include: good manufacturing practices at the time of procurement; formal recommendations from regulatory agencies; registration with the NMRA; and sample-testing by the State Pharmaceuticals Corporation. ^[39] Sarvodaya confirmed that these were standard measures in the context of quality assurance. [40]

Milestones 2.4–2.5: All stakeholders confirmed that no progress was made in introducing a rating system for private pharmacies. [41]

Did It Open Government?

Access to Information: Marginal

Civic Participation: Did not Change

This commitment did not lead to a change in civic participation, but did lead to a limited increase in access to information and thus, a marginal improvement in open government overall.

At the outset of the action plan, the inadequate availability and affordability of essential medicines were a major concern among key stakeholders in the health sector. [42] High costs, tedious drug registration processes, inadequate clinical testing capacities, and strong pharmaceutical lobbying all contributed to concerns about steady access to safe and affordable drugs. [43] This, in turn, led to noncompliance with prescribed drug regimens, and the development of additional health complications, which further burdened public healthcare services. [44]

Although a precise number was not provided, civil society confirmed that a few public health institutions had commenced displaying information on the availability of essential medicines. [45] However, as this was not fully completed—and there was no progress in setting up a pharmacy rating system—the commitment only contributed to a marginal increase in access to information.

The introduction of an online monitoring mechanism at the RMSD level helped inform citizens of the availability of medicines, a marginal achievement in improving access to information. Although there are no statistics on the number of citizens accessing this information, the Department of Census and Statistics reported that only around 25 per cent of the total population used the internet in the first six months of 2018. [46] This statistic points to limitations involved in government attempts to facilitate inclusive access to information through online channels alone. Additionally, the online mechanism did not allow public feedback and, therefore, did not contribute to an improvement in civic participation. The failure to appoint the nominees to the advisory board of the National Medicines Regulatory Authority (NMRA) limited this further. [47]

Carried Forward?

Sri Lanka’s second action plan was not released by the time of this report. Given the importance of ensuring the availability of safe and affordable essential medicines, the IRM researcher recommends that this commitment is carried forward to the next action plan.

However, cognizant of the limited progress achieved, the IRM researcher recommends adapting this commitment to enhance potential impact by better leveraging the principles of open government. A number of such measures were proposed in the 2016–2017 IRM midterm progress report. These include: publishing a trilingual report on measures taken to ensure availability of safe and affordable medicines; introducing grievance redress mechanisms to engage service providers in guaranteeing the availability of safe and affordable medicines; and conducting awareness programs on the availability of such mechanisms.

[22] Dr. Kamal Jayasinghe (National Medicines Regulatory Authority), interview by IRM researcher, 20 October 2017.

[23] National Medicines Regulatory Authority Act, No. 5 of 2015.

[24] Dr. Vinya Ariyaratne (Sarvodaya), interview by IRM researcher, 26 October 2017.

[25] “Item List,” Web Portal, Medical Supplies Division (Ministry of Health – Sri Lanka, 2017) https://www.msd.gov.lk/index.php/web-portals/item-list.

[26] Dr. Susie Perera (Ministry of Health, Nutrition, and Indigenous Medicine) and Dr. Amila Chandrasiri (Ministry of Health, Nutrition, and Indigenous Medicine), interview by IRM researcher, 6 October 2017.

[27] Jayasinghe, interview.

[28] Ariyaratne, interview.

[29] Dr. Susie Perera, interview by IRM researcher, 28 September 2018.

[30] “Item List” (Ministry of Health – Sri Lanka, 2018).

[31] Perera, interview, 28 September 2018.

[32] “Item List” (Ministry of Health – Sri Lanka, 2018).

[33] Perera, interview.

[34] Id.

[35] Dr. Vinya Ariyaratne (Sarvodaya), interview by IRM researcher, 27 September 2018.

[36] Id.

[37] Perera, interview, 28 September 2018.

[38] Id.

[39] Id.

[40] Ariyaratne, interview.

[41] Perera and Chandrasiri, interview, 6 October 2017; Ariyaratne, interview, 27 September 2018.

[42] C. Aloysius, “Drug Price Reduction: A Promise in Waiting” (Sunday Observer, 23 October 2016) http://www.sundayobserver.lk/2016/10/23/wellness/drug-price-reduction-promise-waiting.

[43] G. D. Dayaratne, “Medicinal Drug Policy of Sri Lanka: Some Challenges” (The Island, 6 April 2015) http://bit.ly/2CizcXo.

[44] Perera, interview.

[45] Ariyaratne, interview.

[46] “Computer Literacy Statistics – 2018” (Department of Census and Statistics, January–June 2018), https://bit.ly/2H7ikVg.

[47] Ariyaratne, interview.