EMPOWERING STAKEHOLDERS IN DRUG POLICY MAKING BY RESEARCH EVIDENCE TO IMPROVE REGULATIONS FOR ETHICAL DRUG ADVERTISEMENT TOWARD RATIONAL DRUG USE Pham Huy Dung and Nguyen Thi Kim Chuc Institute for Health Environment and Development

Problem Statement: Consequences of the socio-economic reform and the health sector reform in Vietnam:  Drugs become more available -> no more shortage of drugs  Too many drugs -> foreign and local companies compete for drug sell -> increasing public spending on drugs and making drug advertisement unethical, which could have negative impact on rational drug use.

Objectives  Collect information on drug advertisement  Inform stakeholders in drug policy making about research evidence on unethical drug advertisement for them to improve regulations for drug promotion toward rational drug use  Evaluate change in drug advertisement  Propose new intervention (regulation)

Design,Setting and Population Design: Pre post evaluation of the regulatory status and its impact on advertisements to the public, on advertisements to doctors as well as on promotional practice. Setting and Population: Various stakeholders in drug policy making: the Committee for social affairs of the National Assemble, the Prime Minister Research Commission, the Committee of Science and Education of the Leading Party (the Communist Party), various departments of the Ministry of Health, various non-government association (the Youth Federation, the Women Union, etc.)

Intervention  Research results from a study on country status, regulatory status, drug advertisements to the public, advertisements to doctors and promotional practice in 1998 were used to inform stakeholders in drug policy making about evidence of unethical aspects in drug promotion harmful to rational drug use  The information process has been implemented through meetings, seminars and workshops using the Meta analysis method

Results: Improvement of the Regulatory Status  Ordinance of the national Assemble 39/2001/PL for advertisement  Ordinance of the President November 30,2001 for advertisement  Decree of the Government 59/2002 for advertisement  Decree of the Ministry of Health 2557/2002/QD-BYT for drug advertisements  Decree of the Ministry of Health on the list of drugs that are allowed for advertisement on March 12, 2003

Results: Advertisements and Promotional Practice  Advertisements  Advertisement to the general public: no improvement in generic names and contra- indications, some improvement in FDA approval (0%->22% in radios and TVs; 0%->47% in magazines)  Advertisement to doctors: no improvement in generic names, some improvement in contra- indications (5.6%->55.6%) and in FDA approval (0%-> 34.6%)  Promotional Practice  Improvement in knowledge among doctors, medical representatives and manufacturers

Discussion and Conclusions  Drug advertisement should respond to requirement of drug information  Rapid effect for improvement of the regulatory status  Low effect of the regulatory status on practice  Enforcement of regulations could control some issues such as generic name, contra- indications, FDA approval, etc.  How to control medical representatives?