Regional Mechanism for bulk Purchase of Selected Quality Essential Drugs.

WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR SOUTH-EAST ASIA 20 th Meeting of Ministers of Health Jakarta, Indonesia, 9-10 September 2002 SEA/HMM/Meet.20/4 8 August 2002 REGIONAL MECHANISM FOR BULK PURCHASE OF SELECTED QUALITY ESSENTIAL DRUGS CONTENTS Page 1. INTRODUCTION............................................................................................................... 1 2. ISSUES IN DEVELOPING THE BULK PURCHASE SCHEMES...................................... 1 2.1 Experiences from other Bulk Purchase Schemes.................................................... 1 2.2 What are the drugs?................................................................................................. 1 2.3 Principle of Pre-qualification of Pharmaceutical Manufacturers............................... 1 2.4 Evaluation of Manufacturers..................................................................................... 2 2.5 Criteria for Pre-Qualification..................................................................................... 2 3. ACTIVITIES SO FAR ........................................................................................................ 2 3.1 Health Secretaries Meeting ........................................................................................2 3.2 Potential Suppliers – India, Indonesia........................................................................2 3.3 Drug Regulators in SEAR...........................................................................................3 3.4 Other Potential Benefits..............................................................................................3 4. SEARO’s ROLE IN IMPLEMENTING THE POTENTIAL BPS.......................................... 3 5. CONCLUSION .................................................................................................................. 3 6. POINTS FOR CONSIDERATION ..................................................................................... 4 6.1 Different Countries and Different Interests.................................................................4 6.2 Sub-Regional Coordination in the BPS ......................................................................4 6.3 Local Partners in the BPS...........................................................................................4 Annex − Selected Essential Drugs for Bulk Purchase Scheme ............................................. 5 1. INTRODUCTION At their meeting in August 2001, Health Ministers from countries of the South-East Asia Region expressed concern about the quality of essential drugs and requested WHO to assess whether a Bulk Purchasing Scheme (BPS) for generic Essential Drugs of assured quality would be practical. The focus was on quality first and then on bulk purchase, to decrease health care costs. The Ministers requested the Regional Office to formulate a proposal and present it to the Regional Committee in September 2002. The Health Ministers recommended that “WHO should offer technical support and facilitate activities such as Bulk Purchase Schemes (BPS) for Essential Drugs by generic name, and drug quality control systems, especially for the smaller countries in the Region.” Governments are aware of the limited resources available for health care. Essential Drugs are very cost-effective interventions but only if their quality is assured. Quality essential drugs procured by bulk purchasing enables governments to use the limited resources to the best effect. The proposed BPS has been developed after consultation with various sectors in pharmaceuticals. It is meant to complement existing purchasing systems where appropriate, and is clearly not meant to replace existing systems in a country. It is essentially a technical proposal that requires discussion and decisions by the countries to define the scope and future direction of the initiative. 2. ISSUES IN DEVELOPING THE BULK PURCHASE SCHEMES 2.1 Experiences from other Bulk Purchase Schemes Experiences from Bulk Purchase Schemes in other regions such as the Pacific and the Caribbean have shown that each scheme needed some impetus generated from the region itself, expertise from within the region and decisions at a high political level. A single successful model for bulk purchase does not appear to exist but the modality seems particularly suited to smaller countries. Schemes have to be developed using the strengths in the region and with necessary political decisions. The clear strength in SEAR is the surfeit of manufacturers; careful pre-qualification must be done to ensure quality in this situation of plenty. 2.2 What are the drugs? It would not be possible to develop a scheme based on the 300+ drugs in the WHO Model Essential Drug List with many formulations, in the short first phase of a year. Therefore, a list of commonly used essential drugs (oral formulations only) was identified and the first phase of the scheme would be based on this list (see Annex). 2.3 Principle of Pre-qualification of Pharmaceutical Manufacturers Pre-qualifying manufacturers rather than including all registered manufacturers as suppliers is increasingly being used to assure quality. It has been used with great success in vaccines for childhood immunization and also in supplies such as condoms. The World Bank has recently accepted pre-qualification and does not, as previously, insist on the lowest bid in an open tender being accepted. SEA/HMM/Meet.20/4 Page 2 Pre-qualification ensures quality. Thus, the lowest offer from manufacturers who have pre-qualified ensures a quality product in a competitive environment. The SEARO Bulk Purchase Scheme for Selected Quality Essential Drugs (BPS SQED) has pre-qualification as the centrepiece for ensuring quality. However, ensuring quality could have an impact on the cost of the product. Thus, countries need to consider the scheme in the context of limited resources available for health. 2.4 Evaluation of Manufacturers It would be ideal for SEARO to inspect the manufacturing facilities of companies that would be potential suppliers to this scheme; however, it is impractical as there would be hundreds of manufacturers. The WHO Good Manufacturing Practices (GMP) Certificate scheme provides a suitable entry point for pre-qualification. WHO, in its technical role has provided the guidelines for the scheme to the countries, who, in turn, implement it through inspections by their Drug Regulatory Authorities (DRAs). The GMP certificate issued is therefore the responsibility of the DRA and not WHO and it is difficult at times to ensure a consistent quality. Thus, WHO’s GMP certificate would serve as the entry point and further steps are needed for pre-qualification. 2.5 Criteria for Pre-Qualification The first criteria for pre-qualification is inspection and approval of a pharmaceutical manufacturing facility by an internationally recognized DRA. The second criterion is the ability of the manufacturers to manufacture to the standard pharmacopeial specifications and the third is an export performance of at least 3 years. These pre-qualification criteria could be modified according to the needs of individual countries in the Region. For example, pharmaceutical companies pre-qualified to supply other UN agencies such as UNICEF could be considered; countries while retaining quality as the centrepiece could modify the pre-qualification criteria to suit their needs. 3. ACTIVITIES SO FAR 3.1 Health Secretaries Meeting The scheme was presented at the Health Secretaries Meeting in New Delhi in April 2002 and specific issues that may arise (registration of products in BPS, national financial regulations on pre-qualification, regulations on foreign suppliers) were discussed. 3.2 Potential Suppliers – India, Indonesia The scheme was presented to selected Indian Pharmaceutical companies (who are the major suppliers in the Region) at a meeting; there was interest as well as discussion of possible bottlenecks. The scheme has also been discussed with Indonesian manufacturers who were interested in selected essential drugs that were routinely manufactured by them. It is hoped to discuss the scheme with Thai Pharmaceutical Manufacturers as well. The other countries in the Region do not have manufacturers that have been inspected and approved by the international DRAs that have been specified and therefore do not qualify to be suppliers according to the proposed criteria. However, if these manufacturers were to be included with modified pre-qualification criteria, they too would be invited to participate in the scheme. SEA/HMM/Meet.20/4 Page 3 3.3 Drug Regulators in SEAR The scheme was finally discussed at a meeting of Drug Regulators in SEAR in late June. Here, the regulators described what steps had been taken in their countries to improve the quality of essential drugs; some countries were able to manufacture most of their requirements of essential drugs and the BPS had the potential of setting back these manufacturers as they were not included in the suppliers. They emphasized that a fine balance needs to be struck between the level of quality and encouraging local manufacture in the Region. There were also some apprehensions about the effect this scheme would have on the local DRAs as well as regulatory capacity. 3.4 Other Potential Benefits A list of pre-qualified manufacturers from SEAR would be useful to other international agencies too and for SEARO procurement itself. Presently, SEARO does not implement prequalification when purchasing pharmaceuticals. Multilateral initiatives such as the Global Fund for AIDS, Tuberculosis and Malaria would prefer that drugs be bought by the countries from a pre-qualified list of suppliers. 4. SEARO’s ROLE IN IMPLEMENTING THE POTENTIAL BPS The Regional Office would, as mentioned previously, be an information provider in this scheme and its role would be to bring pre-qualified suppliers and countries together to negotiate the quantities and the prices of the essential drugs. The Regional Office would act as an “honest broker” in bringing the two parties together and assist in technical matters. A more advanced model is possible but requires more resources and therefore has to be considered within that context; this model may be more appropriate for the smaller countries. If a country specifies its requirements to WHO, the latter would then get the best prices from the pre-qualified manufacturers for the country. Additionally, if countries could agree on common specifications for purchasing essential drugs, the Regional Office could facilitate joint purchase by the countries. The economies of scale this would produce could lead to a further decrease in prices. 5. CONCLUSION The object of the WHO Medicines Strategy is to help save lives and improve health by closing the huge gap between the potential that essential drugs have to offer and the reality that for millions of people, particularly the poor and disadvantaged, medicines are unavailable, unaffordable, unsafe or improperly used. The Health Ministers meeting in August 2001 expressed concern and requested SEARO to concentrate on mechanisms for procuring Quality Essential Drugs. The same concerns were reflected in the Global Agenda in the World Health Assembly in May 2002. These address the constituency that needs it the most – quality essential drugs for the poor, the marginalised and the disadvantaged. The proposed BPS now requires discussion, evaluation and future direction from the Member Countries. The current proposal is analogous to a limited buffet meal with few items of good quality made by a few chefs, that is, a small number of commonly-used essential drugs made by an even smaller number of pre-qualified manufacturers from one or two SEA/HMM/Meet.20/4 Page 4 countries. Would the countries like to sample this “meal” now, or would they want to enlarge the meal further? 6. POINTS FOR CONSIDERATION It is unlikely that all countries in SEAR would be equally interested in this BPS due to the very different pharmaceutical situation in the individual countries. 6.1 Different Countries and Different Interests Some countries may see this scheme as being useful for purchasing whereas other countries may want their manufacturers to be the suppliers. Other countries may see this scheme (or the process of pre-qualification) as useful for particular drugs. Some countries may wish to buy a few drugs through this scheme to compare it with existing systems and products. 6.2 Sub-Regional Coordination in the BPS Due to the heterogeneity of the Region, similar countries may prefer to develop their own standards in pre-qualification. Potential buyers may develop their own pre-qualification criteria and potential suppliers could propose their pre-qualification criteria too. The political and economic impetus for such work could be through ministerial cooperation. SEARO could provide the technical and financial support needed for the meetings and other activities that will develop these pre-qualification criteria. Such activities would have the participation of the Drug Regulatory Authorities in those countries as well as the supply divisions in the respective ministries of health. 6.3 Local Partners in the BPS Some countries may desire greater involvement of local partners as the BPS could also be seen as an exercise in developing local capacity towards the final goal of the country developing self-sufficiency in essential drugs. A common problem in this area is the maldistribution of pharmaceuticals which would negate what has been achieved with the BPS. If a country has no suitable local manufacturer, then in the BPS, a supplier from abroad would be inevitable. However, the supplier could be required to link with a local distributor as a part of the contract to deliver the drugs. This way, not only quality drugs but expertise and systems to distribute pharmaceuticals will follow. SEA/HMM/Meet.20/4 Page 5 Annex SELECTED ESSENTIAL DRUGS FOR BULK PURCHASE SCHEME Drug Dosage Form Dose 1. Albendazole Tablets 400mg 2. Aluminium hydorxide Tablets 3. Amoxicillin Capsules 250mg 4. Aspirin Tablets 300mg 5. Atenolol Tablets 50/100mg 6. Chloroquine Tablets 100mg 7. Chlorphenamine Tablets 4mg 8. Chlorpromazine Tablets 100mg 9. Cimetidine Tablets 200mg 10. Diazepam Tablets 5mg 11. Erythromycin Caps/Tablets 250mg 12. Ethambutol Tablets 100mg 13. Ferrous Salt Tablets Equiv to 60mg 14. Furosemide Tablets 40mg 15. Glibenclamide Tablets 2.5/5mg 16. Hydrochlorothiazide Tablets 25/50mg 17. Ibuprofen Tablets 200/400 mg 18. Isoniazid Tablets 100mg 19. Mebendazole Tablets 100mg 20. Metoclopramide Tablets 10mg 21. Paracetamol Tablets 500mg 22. Phenoxymethilpenicillin Tablets 250mg 23. Phenytoin Tablets/Capsules 100mg 24. Prednisolone Tablets 5mg 25. Primaquine Tablets 7.5mg 26. Promethazine Tablets 25mg 27. Pyrazinamide Tablets 400mg 28. Rifampicin Capsules 150mg 29. Salbutamol Tablets 2/4mg 30. Sulfamethoxazole + trimethoprim Tablets 400+80mg