1. In recognition of the challenges faced by Member States to achieve availability and accessibility of essential drugs and the complexities involved, the following recommendations are made:

• Experience from countries facing economic crises demonstrate that the following basic principles should be adopted in an integrated manner, focusing on population groups most in need.

• Essential drugs and generic drug policies should already be in place and implemented.

• A decentralized drug management system for recording and reporting should be supported by appropriate guidelines.

2. Procurement for the most needed essential drugs should be pooled and followed by monitored distribution. National essential drug programmes should be made sustainable through mechanisms such as revolving funds, cost-sharing and cost-containment.

3. In order to ensure availability and accessibility to essential drugs at primary levels of health care:

• Essential drugs lists should be formulated for different levels of health care.

• Diagnosis and standard treatment guidelines should be developed and adopted for each level of health care.

• An enabling environment should be created for prescribers and other health care providers to improve availability of essential drugs within their scope of practice.

4. In order to improve drug donation practices:

• WHO should be proactive in promoting the WHO guidelines for drug donations.

• All donor and recipient countries should adopt and comply with these guidelines.

• There should be close collaboration between regulatory authorities in donor and recipient countries.

• Mechanisms should be established for the timely exchange of regulatory information between donor agencies and regulatory authorities.

• Countries should develop administrative procedures for accepting drug donations and disseminate them to all relevant agencies.

5. In order to improve access to essential drugs, drug regulators should:

• Ensure timely availability of essential drugs through expedited review and approval processes without compromising drug quality, efficacy and safety.

• Facilitate authorization of medicines considered to be major therapeutic advances through information exchange between regulators.

• Harmonize regulatory requirements and promote closer cooperation among regulatory authorities.

6. In order to make drugs affordable, drug regulatory authorities should:

• Establish legislation for generic substitution.

• Ensure timely authorization of generics.

• Establish mechanisms to facilitate introduction of generics promptly after patent expiry.

7. WHO should assist Member States in the implementation of the above recommendations as appropriate, and seek support from bilateral and multilateral agencies to ensure sustainable drug supply at peripheral levels of health care.