Selection of essential drugs

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Promoting transparency and accountability – a necessary condition for successful pharmaceutical policy implementation

I. Introduction

“… corruption is a worldwide problem, existing
in both high- and low-income countries…
Thus no country should feel offended and restrained
to talk about it; most countries have reason to look
critically at their current situation and should
decide how they can promote good governance.”
Dr Hans Hogerzeil, WHO, 2006 [3]

Effectiveness of a pharmaceutical policy depends on many factors. Unethical or corrupt practice can highly influence the results. It can lead to reduced quality of health care, shortages of medically needed medicines and medical suppliers, unsafe and poor quality products on the market, financial loses for health systems due to irrational use of medicines through unethical promotion, and the undermining of public trust in science [6].

At present a pharmaceutical system’s vulnerability to corruption and unethical practice is widely discussing. The reasons of such vulnerability are:

• the “medicines chain” includes many different steps starting from R&D and ending with the consumption of the medicine by the patient;
• a numerous number of interested parties who are very different in their objectives;
• an imbalance of information;
• the uncertainty in health markets.

There are numerous reasons for existence of unethical or corrupt practice in Armenia in general and in the pharmaceutical sector in particular.
There are still many causes for corruption existence in Armenia [4]:

• Distracted perceptions of the significance, role, and functions of the state;
• Infringements upon a predominant attribute of a legal state, i.e. the rule of law;
• The incomplete separation of executive, legislative, and judicial powers;
• The public apparatus, which is socially and financially vulnerable, yet inflated in size, and renders public administration inefficient;
• The unbearable scale of the "grey" economy;
• The imperfection of democratic institutions;
• The inefficient and inaccessible representation of political and economic strategies to the public in the development of a new societal system;
• The underestimation of the anti-corruption element in the legislative process;
• The inadequacy of the law-enforcement system and judiciary in detecting corruption crimes and punishing corrupt entities, as well as breaches of the principle of inevitability of punishment;
• Inadequacy of mechanisms to protect human and citizen rights, the legislation, and social justice;
• Poor oversight and scrutiny over the performance of public administration functions; and
• The passive or selective engagement of the mass media in [covering] social and political events.

2. Problem description

2.1 Access to medicines

Due to lack of transparency and accountability there is no enough and reliable official information about a level of access to medicines in Armenia.

However, some information collected from key informants, publications and unpublished reports demonstrates existence of factors directly justifying about a lack of conditions necessary for providing access to medicines. The results of study implemented by DURG (NGO implementing research related to the pharmaceutical service and policy) show that availability of essential medicines at public medical establishments in 2005 is still less than 50%. Similarly, appropriateness of centrally purchased medicines to the National Essential Medicines List since 2001 was lower than 33%. Number of medical establishments where a Drug and therapeutic committee exists, has decreased since 2001.

2.2 Quality of medicines

Counterfeit medicines continue to be founded at the pharmaceutical market.

2.3. Rational drug use

Only less than 40% physicians at policlinics in Yerevan use Standard Treatment Guidelines in their routine practice. All pharmacies dispense prescription medicines (excluding narcotics and psychotropic medicines) without prescription.

3. Policy options

4. Conclusions

1. There is a lack of transparency and accountability in the Armenian pharmaceutical sector.
2. Introducing real mechanisms providing transparency and accountability will lead to improving the situation in the pharmaceutical sector.
3. Despite the fact that local professional do not have enough knowledge about transparency and accountability, there is believe in their high value for the pharmaceutical sector.
4. Transparency and accountability are necessary prerequisites of pharmaceutical policy effectiveness.
5. Approval of Code of conduct and making it publicly available can lead to a better quality of the pharmaceutical service.

5. Recommendations

5.1 Legislation

To insert changes in the Law on “Medicines” related to requirement of transparency, accountability and code of conduct for regulatory work and all other aspects of activity in the pharmaceutical sector.
To develop and approve regulation on a National Pharmaceutical Policy process and to make it publicly available.
To develop and approve regulation covering code of conduct for officials in the Health care system and the Pharmaceutical sector.
To develop and approve a Law or regulation covering in detail Ethical criteria for promotion of medicines.

5.2 National Pharmaceutical Policy

To involve all the interested stakeholders, including civic organizations, in consultations related formulating and then - in evaluating a National Pharmaceutical Policy process.
To involve Media in a National Pharmaceutical Policy process.
To complete consultations and approve National Pharmaceutical Policy document; to make it publicly available.
Constantly to provide public awareness on the current stage of a National Pharmaceutical Policy process (formulating, implementing, monitoring and evaluating).

5.2 Regulation

To develop and approve a public document (operational practice) that describes in detail registration of medicines.
To publish and disseminate regulatory policies, procedures and criteria for decisions made to all stakeholders.
To discuss issues of common concern and procedures with stakeholders.
To publish guidelines to promote understanding of medicines regulation and facilitate their implementation.
To provide regular reports on activities to the supervisory authorities and the public.
To establish mechanisms for dealing with complaints from the public.
To establish a system of promotion and advertisement control with results published.
To provide that information on counterfeit medicines is publicly available.

5.3 Financing

To provide availability of complete information on pharmaceutical expenditures allocated in the state budget (including those allocated for hospitals and primary health facilities), as well as factual public expenditures on medicines.

5.4 Selection of medicines

To develop and approve criteria for selecting medicines for the national EML and to make it publicly available.
To develop and approve a public document (operational practice) that describes in detail process of including medicines in and eliminating from national EML; to include in this practice consultations with interested parties; to make this consultations process publicly available.
To create at the Ministry of Health a special committee on the national EML responsible for all aspects of activity related to Standard Traetment Guidelines and essential medicines; to develop clear criteria for the committee membership.
To develop and approve criteria for selecting medicines for the hospital (any other medical establishment) formulary and to make it publicly available.

5.5 Supply

To develop and approve operating procedures for medicines procurement, including criteria for tender and make them publicly available.
To involve a civil society at all the stages of the centralized procurement process.
To make publicly available a detailed information on the results of the medicines centralized procurement, including prices and volumes.
To develop and approve criteria for managing drug donation (selecting, determining quantity, distributing).

5.6 Distribution

To develop, introduce and monitor a comprehensive system of accountability for distributing medicines bought using public funding.
To involve civic organizations in audit.

5.7 Use

To support and promote a system of pharmacovigilance.
To organize on regular basis medicines prescribing monitoring; to make the results publicly available.
To develop and introduce a national system of medicines statistics (utilization of medicines).

5.8 Training

To provide training of all the public servants and other persons responsible for decision-making in the pharmaceutical sector in the area of transparency, accountability and ethical practice.

Attachment 1

Definitions

1. “Consultations” are those processes through which the Government (the Ministry of Health) wishes to trigger input from interested parties for the shaping of policy prior to a decision by the Commission.
2. “Interested parties” means all who wish to participate in consultations run by the Government (the Ministry of Health), whether they are organizations or private citizens.

REFERENCES

1. Cohen, J. C., Cercone, J. A., and Macaya, R. Improving Transparency in Pharmaceutical Systems: Strengthening Critical Decision Points Against Corruption. Latin American and Caribbean Region: Human Development Network. World Bank, Washington, DC, 2002.

2. Corruption in the health sector. U4 Issue 1:2006 (pdf-version of Theme pages on www.u4.no).

3. Dyer O. New report on corruption in health. Bulletin of the World Health Organization, Vol.84, N.2, WHO, Geneva, February 2006.

4. Republic of Armenia Anti-corruption strategy and implementation action plan. Yerevan, 2003.

5. World Health Organization, Effective medicines regulation: ensuring safety, efficacy and quality, WHO Policy Perspectives on Medicines n°7, WHO, Geneva, November 2003.

6. WHO Medicines strategy. Countries at the core 2004-2007. WHO, 2004.