ACCOUNTABILITY AND TRANSPARENCY IN THE PHARMACEUTICAL SECTOR: IS IT VALUABLE AND POSSIBLE?

CHAPTER 1.

Objectives

• to estimate legal base for the activity connected to medicines, from the point of view of providing the accountability and transparency;
• to study and analyze opinion of public health experts concerning a present situation and importance of these strategies in the Armenian pharmaceutical sector.

Methods

The contents of corresponding laws and under-legislation acts have been analyzed. Questionnaires have been developed (see attachment 2), in which respondents have been asked to estimate using a five-point scale the current situation and to determine importance of providing accountability and transparency on 13 main components of pharmaceutical management. The filled questionnaires have been received from 72 respondents (representatives of administration of the public medical enterprises, heads of hospital pharmacies and so forth). 136 professionals (72 – the same respondents and 74 additionally involved) were asked on necessity of a wide use of accountability and transparency for sphere of management and regulation of medicines.

Results

The majority of documents do not cover the requirements concerning the accountability and transparency. When estimating the current situation, respondents frequently have selected the answer “have no sufficient data”. "5" points have been exposed only 4 times, two of which by two participants for the point “Purchases and distribution of medicines in medical establishments”. Any component has not received a positive mark by even a half of respondents. 25 % of respondents have marked "1" for situation in the spheres of inspection and the control of advertising. Only 2 participants do not consider a wide use of accountability and transparency to be necessary for sphere of management and regulation of medicines. Providing these approaches, when counterfeit medicines have been found, have been accepted as very important by the greatest number of respondents (80,5 %).

Table1. Assessment of accountability and transparency in the pharmaceutical sector by Health care system professionals

Component in the pharmaceutical sector	Percentage of respondents who gave appropriate marks for accountability/transparency
	1/1	5/5	No enough information to asses
Centralized procurement	8,3/11	1,4	66,7
Distribution of medicines purchased	11/3,9	1,4	61,0
Licensing	13,9	2,8	61,0
Registration	22,2	2,8	47,0
Inspection	25,0	0	47,0
Quality control	22,2	1,4	48,6
Counterfeit medicines	13,9	1,4	44,4
Control of advertisement	25,0	5,6	52,8
Monitoring adverse reactions	13,9	0	58,3
Clinical trials	2,8	1,4	70,8
Medicines policy	13,9	2,8	41,7
Formulating EML	16,7	2,8	50,0
Medicines purchasing and distribution at the medical establishments	8,3	6,9	45,8

Figure 1. Opinion of professionals on necessity of a wide use of accountability and transparency for sphere of management and regulation of medicines

Conclusions

It is revealed, that almost all interrogated experts of public health services consider wide use of accountability and transparency to be necessary in the area of managing medicines supply. Introduction of appropriate requirements in the legislative documents related to medicines is necessary.

CHAPTER 2.

Objectives

• to study the situation on pharmaceutical expenditures and to develop appropriate recommendations.

Methods

Documents review; collecting information from records and the National Statistical Service; interviewing key staff.

Results

Real Public Health Expenditures for 10 years

A. In Armenian Drams (AMD)

B. In percentages of GDPPublic Pharmaceutical Expenditures for Centralized Procurement of Medicines

Planned in the State Budget, mln. USD

Drug donations

Drug sales

Household Pharmaceutical and Health Expenditures

A. Average monthly expenditures for one household member

B. Pharmaceutical expenditures of total household expenditures, AMD

Table 2. Total pharmaceutical consumption

Conclusions

This leads to the situation when many patients lack access to essential medicines. Recommendations on increasing public pharmaceutical expenditures and other strategies for improving affordability of medicines were presented to the Ministry of Health. Access to information should also be amended. Accountability and transparency mechanisms have to be introduced.

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.

7. Good drugs at low cost: Thailand’s provincial collective bargaining system for drug procurement. Essential Drugs Monitor, 1998, N25&26: 5-7.

8. Improving the supply, quality control and access to essential drugs in Guatemala. Essential Drugs Monitor, 1998, N25&26: 12-13.

9. Management Sciences for Health (1997). Managing Drug Supply: The Selection, Procurement, Distribution and Use of Pharmaceuticals, 2nd edn, Management Sciences for Health in collaboration with the World Health Organization. Kumarian Press, Hartford, CT.

Attachment 1.

Core Indicators

1. Legislation

1.1 Does legislation require transparency, accountability and code of conduct for regulatory work in the pharmaceutical sector?
1.2 Is there approved Law or regulation on a National Pharmaceutical Policy process?
1.3 Is it publicly available?
1.4 Is there code of conduct for:
Civic servants in general?
Officials in the Health care system?
Officials in the Pharmaceutical sector?
1.5 Is there a law or regulation prohibiting members of the drug slection committee from accepting support in kind or in cash from pharmaceutical companies?
1.6 Is there approved Law or regulation covering in detail Ethical criteria for promotion of medicines?

2. National Pharmaceutical Policy

2.1 Are all the interested stakeholders, including civic organizations, involved in a National Pharmaceutical Policy process (formulating, evaluating) ?
2.2 Is Media involved in a National Pharmaceutical Policy process?
2.3 Is National Pharmaceutical Policy document publicly available?
2.4 Is public aware on a regular basis about all stages of National Pharmaceutical Policy process (formulating, implementing, monitoring and evaluating)?

3. Regulation

3.1 Is there a public document that describes how to register a drug in this market?
3.2 Are regulatory policies, procedures and criteria for decisions made published and disseminated to all stakeholders?
3.3 Are issues of common concern and procedures are discussed with stakeholders?
3.4 Are guidelines to promote understanding of medicines regulation and facilitate their implementation published?
3.5 Are regular reports on activities provided to the supervisory authorities and the public?
3.6 Is an independent appeals system created for regulated firms?
3.7 Are mechanisms for dealing with complaints from the public established?
3.8 Is there a system of promotion and advertisement control with results published?
3.9 Is information on counterfeit medicines publicly available?

4. Financing

4.1 Are pharmaceutical expenditures allocated in the state budget (including those allocated for hospitals and primary health facilities) publicly available?
4.2 Are factual public expenditures on medicines are publicly available?

5. Selection of medicines

5.1 Are there approved criteria for including and eliminating drugs from the national EML/formulary?
5.2 Are they publicly available?
5.3 Are there clear criteria for committee membership?
5.4 Are there approved criteria for including and eliminating drugs from the hospital (any other medical establishment) formulary?

6. Supply

6.1 Are there approved operating procedures for medicines procurement, including criteria for tender?
6.2 Are these written procedures publicly available?
6.3 Does the procurement unit have an annual audit with published results?
6.4 Are the drug procurement prices made publicly available?
6.5 Is civil society involved at all stages of the rocess?
6.6 Are there approved criteria for managing drug donation (selecting, determining quantity, distributing)?

7. Distribution

7.1 Are there independent audits of warehouses by national inspectors or outside contractors?
7.2 Is there a coding used to identify government drugs?

8. Use

8.1 Is there system of monitoring medicines prescribing with published results and analysis?
8.2 Is there system of pharmacovigilance with published results and analysis?

9. Training

9.1 Are public servants and other persons responsible for decision-making in the pharmaceutical sector, trained in the area of transparency, accountability and ethical practice?

Attachment 2.

Questionnaire for Health care professionals
Part 1.

Please, assess accountability/transparency in each component of the pharmaceutical sector and circle an appropriate mark

Component in the pharmaceutical sector	Marks for accountability/transparency
Centralized procurement	1/1	2/2	3/3	4/4	5/5	No enough information to asses
Distribution of medicines purchased	1/1	2/2	3/3	4/4	5/5	No enough information to asses
Licensing	1/1	2/2	3/3	4/4	5/5	No enough information to asses
Registration	1/1	2/2	3/3	4/4	5/5	No enough information to asses
Inspection	1/1	2/2	3/3	4/4	5/5	No enough information to asses
Quality control	1/1	2/2	3/3	4/4	5/5	No enough information to asses
Counterfeit medicines	1/1	2/2	3/3	4/4	5/5	No enough information to asses
Control of advertisement	1/1	2/2	3/3	4/4	5/5	No enough information to asses
Monitoring adverse reactions	1/1	2/2	3/3	4/4	5/5	No enough information to asses
Clinical trials	1/1	2/2	3/3	4/4	5/5	No enough information to asses
Medicines policy	1/1	2/2	3/3	4/4	5/5	No enough information to asses
Formulating EML	1/1	2/2	3/3	4/4	5/5	No enough information to asses
Medicines purchasing and distribution at the medical establishments	1/1	2/2	3/3	4/4	5/5	No enough information to asses