[e-drug] Draft Sri Lankan National Drug Policy for comments

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: Draft Sri Lankan National Drug Policy for comments
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The Draft National Medicinal Drug Policy of Sri Lanka has been published for comments. See below.

The Ministry is asking for comments and although not on the website, the email for comments is
ddgls@health.gov.lk  or  chintab@sltnet.lk

The official in charge is 

Dr Ajit Mendis
Deputy Director General, Laboratory Services (hence the ddgls in the email)
Ministry of Health
Suwasiripaya
385 Deans Road
Colombo 10
Sri Lanka

--- 
http://www.health.gov.lk/Documents/DraftNMDPSRLFeb05v4.doc

DRAFT NATIONAL MEDICINAL DRUG POLICY FOR SRI LANKA

Preamble

Sri Lanka had a written/unwritten Drug Policy from the 1960s. It was written as elements of a policy, beginning from selection of drugs for the government drug supply and the Ceylon Hospitals Formulary in early 1960s, the Bibile Wickremasinghe report in 1971, the Cosmetics Devices and Drugs Act (1980). However there was no comprehensive document.

There were attempts to develop a NMDP in 1991 & 1996; while the documents were accepted by the Ministry of Health, they did not reach the final step of cabinet approval. Hence no comprehensive document exists at present. The present effort building upon previous efforts brings together the elements of a National Medicinal Drug Policy (NMDP) in one document and has been developed based on WHO documents through discussion with all stakeholders. It is hoped that this effort will see a formal National Medicinal Drug Policy being adopted by the cabinet for the country. 

The objectives of the Sri Lankan National Medicinal Drug Policy are

1.         To ensure the availability, affordability of efficacious, safe and good quality medicines relevant to the health care needs of the people in a sustainable and equitable manner. 

2.         To promote the rational use of these medicines by healthcare professionals and consumers. 

3.         To promote local manufacture of Essential Medicines. 


The Sri Lankan National Medicinal Drug Policy 

1.         will be within the overall health policy of the country

2.         will be based on the Essential Medicines Concept

3.         will be focused on the health sector but include the relevant areas such as education, finance, pharmaceutical industry and trade

4.         will safeguard the rights of the patients/consumers


An NMDP should cover all systems of medicine including allopathic, homeopathy, ayurveda, sidda, unani and any other systems recognised in the country. The primary concern of this policy is allopathic medicines; however policies for the others systems of medicines will be developed in consultation with stakeholders of those systems.

The Sri Lankan NMDP will have the following elements

1.         Selection of essential medicines

2.         Affordability and Equitable Access

3.         Financing options

4.         Supply systems and Donations

5.         Regulation and quality assurance 

6.         Quality Use of Medicines 

7.         Research 

8.         Human resources 

9.         Viable Local Pharmaceutical Industry

10.       Monitoring and evaluation 


Selection of essential medicines 

The selection of an Essential Medicines List prioritises the medicines that are important. The medicines will be selected according to sound and adequate scientific evidence, the disease pattern in the country and cost-effectiveness.

A National Standing Committee comprising all stakeholders will be established to define and regularly update the National Essential Medicines List. This committee will also oversee the implemetation of medicines policies. It will formulate, review and update Standard Treatment Guidelines, Drug Index, the Sri Lankan Formulary and Government Drug Procurement Documents.

Affordability and Equitable Access

A Pricing Policy/Mechanism should be adopted to ensure affordability. Legislation requiring generic prescribing and allowing cost-effective generic substitution should be enacted. There shall be a policy for licensing pharmacies which among others would incorporate the needs and requirements of the communities. 

Medicines including raw materials should be imported free of any taxes and other tariffs. The public health provisions of the Doha Declaration (Parallel Imports, Compulsory Licensing) should be incorporated into the national legislation to ensure affordability of needed medicines. Rational self medication will be facilitated by appropriate scheduling of the medicines.

Financing options

The State should provide sufficient funding for procurement and supply of Essential Medicines, monitor appropriate use and prevent waste. Public and private sector health insurance schemes will be encouraged to develop re-imbursable lists of medicines.

Supply systems & Donations

The responsibility for ensuring a continuous availability of Essential Medicines in the country is a shared public/private sector responsibility. The State should continue centralised bulk purchase and supply to its institutions. Preference should be given to local manufacturers in supply of medicines to the state sector. Good pharmaceutical procurement practices and management of the supply chain should be enacted for both the public and private sector.

There should be a private/public mix of suppliers to the private sector. 

A policy for acceptance of donations of medicines should be developed based on WHO Guidelines for Drug Donations. Until this policy is developed the WHO guidelines should be followed.

Regulation and quality assurance 

Legislation should be enacted to provide a sound legal basis for regulating activities in medicines.  An Autonomous Medicinal Drug Regulatory Authority (AMDRA) under the Ministry of Health with transparent, accountable mechanisms and adequate human resources should be established. Medicines should be registered based on the criteria of quality, safety, efficacy, need and cost-effectiveness. Official drug information will be instituted through approval of Product Information Leaflets/Summary of Product Characterisitics and where relevant Patient Information Leaflets. 

The Authority should be funded by the state and through statutory levies on services rendered. An accredited Drug Quality Assurance Laboratory should function within the Authority with appropriate fees for services. 

Good Manufacturing Practices (GMP) compliant with WHO Guidelines should be required for registration of medicines. Good Pharmacy Practices (GPP) and Good Distribution Practices (GDP) should be developed and implemented.  

The promotion of medicines should be regulated based on the Sri Lanka Medical Association Ethical Criteria for Medicinal Drug Promotion. Post-marketing surveillance and adverse drug reaction monitoring systems should be established.

Quality Use of Medicines 

Appropriate education in the quality use of medicines should be included in the training of healthcare professionals. The state should fund a national medicines information center to provide independent and unbiased information to healthcare professionals and consumers.

The rational use of drugs should be promoted. Measures should be taken to prevent irrational use promoted by financial and other incentives. There should be public education programs about medicines especially through the school curricula.

Research 

There should be resources and incentives for operational research in issues on access to medicines, quality, storage and utilisation. The findings of research in medicines should be incorporated into clinical practice. 

Clinical research into drugs for neglected diseases which are prevalent in Sri Lanka should be encouraged. 

Contract research in drug development should be in keeping with WHO Good Clinical Practice Guidelines.

Human resources 

The state should be solely responsible for planning and developing the human resources in the pharmaceutical sector. The major responsibility for training will be with the state. There should be a special focus on the development of the pharmacy profession with degree programs in pharmacy. The Pharmacy Council should be established as a priority. There is a necessity for external technical cooperation for the development of human resources in the pharmaceutical sciences. Expertise in Clinical Pharmacology/Clinical Pharmacy needs to be developed and utilised in the health care sector.

Viable Local Pharmaceutical Industry

The state should encourage and facilitate a viable sustainabel local pharmaceutical industry by fiscal and other incentives. This will allow better monitoring of quality, improve availablity, affordability, employment of skilled personnel and development of technical and human resources. 

The State Pharmaceuticals Corporation (SPC) and the State Pharmaceuticals Manufacturing Corporation (SPMC) should be solely owned and managed by the state. Both corporations should facilitate training for the pharmaceutical sector. The SPC/Medical Supplies Division should procure the state requirements of pharmaceuticals from the SPMC. The close collaboration of SPC and SPMC is essential for a strong state sector in pharmaceuticals. 

The local pharmaceutical industry should be given priority over imports in state procurement. 

Monitoring and evaluation 

An inspection system should be established at the AMDRA for GPP, GMP, GDP by the appropriately qualified personnel. Regular Monitoring of the Pharmaceutical Sector through indicator-based surveys should be conducted by the National Standing Committee. 

This policy will be reviewed, and revised if necessary in five years.

09 February, 2005