The 2012 conference focused on the importance of an effective, enacted national medicines policy in ensuring access to good quality medicines and their rational use. The range of countries, their sizes and economic diversity mean that the challenges of policy implementation differ. Some countries have substantial local manufacturing and export medicines, others are completely reliant on imports. While some countries have embraced information technology using data for real-time analysis of medicines use, others have few data for monitoring performance and informing policy development. The policy themes of 1995 remain largely unchanged in 2012, however there are new challenges in each of the policy areas.
Safe, effective, good quality medicines
While international attention focuses on fraudulent or counterfeit medicines,7,8 a big concern is poor quality (substandard) medicines. A study of 1437 samples of five classes of antimalarial drugs purchased in South East Asia between 1999 and 2010 found that 35% failed chemical analysis, 46% of 919 failed packaging analysis, and 36% of 1260 were classified as falsified (counterfeit).9 In 2008, a heparin produced with contaminated raw material procured from Asia caused deaths in the USA.10 Unregulated companies and poor adherence to good manufacturing practice and international regulatory standards threaten medicine users worldwide, particularly in countries which are reliant on imports but lack their own regulatory framework or laboratory testing capacity.
Possible responses to these challenges include regional sharing of information about manufacturing quality, strengthening the capacity of drug regulatory authorities for quality assurance activities, enforcement of regulations, and legal prosecutions. Medicines inspectors need to be empowered to act – to seize goods and shut down operations when necessary – and to be trained in the evidential standards needed for successful prosecutions. The plethora of medicine products, inadequate numbers of qualified staff and corruption threaten these regulatory efforts. Agencies like the TGA have an important role in undertaking product testing and supporting capacity building in the region through leadership and sharing information.
Medicines safety is more than adverse drug reaction reporting. While the World Health Organization (WHO) provides guidelines for establishing pharmacovigilance centres,11 these centres are not feasible in many smaller countries. In addition, these centres do not deal with other safety problems related to poor quality medicines (substandard or counterfeit products), or physical problems (for example products degraded by poor storage conditions or a lack of refrigeration).
There is an important role for medication error reporting systems to cover problems related to dispensing, prescribing and administering of medicines. Equally important is the ability to investigate and respond to these problems. This is a particular challenge when implementing national medicines policies with limited resources. These countries will need access to external experts and laboratories to support investigations until they build their own local capacity.
Affordable access to medicines
An emerging challenge is the transition from the treatment of acute disease and infections to the management and prevention of chronic disease.12 ‘Vertical disease’ programs, supported by international donors, have had enormous success in delivering both health care and medicines for tuberculosis, malaria and HIV. However, sustained efforts will be required to ensure adequate funding for medicines to treat chronic non-communicable diseases such as diabetes and cardiovascular disease. Without attention to this emerging need, there will be more examples of ‘I wish I had AIDS’, in response to the relatively poor access to affordable treatment for patients with diabetes compared to HIV in Cambodia.13
Health insurance schemes have the potential to improve affordable access to medicines in the region. An important consideration is what is included in a minimum benefits insurance package, balancing healthcare needs with financial constraints. Poor medicines coverage policies that do not meet prioritised healthcare needs may threaten the viability of these insurance schemes. The conference posed the difficult ethical question that if it is not possible to provide universal coverage, how can we best allocate the resources available?
Generic medicines have a key role in cost containment and for increasing affordable access to medicines. However, concerns about the quality of generic medicines in some countries create mistrust and poor acceptance by consumers and prescribers. While drug regulatory authorities have an important role in assessing bioequivalence and ensuring manufacturers comply with good manufacturing practice, education strategies are also needed to promote confidence and more widespread acceptance and use of generic medicines.
Rational use of medicines
It has been suggested that policies relating to the rational use of medicines (called quality use of medicines in Australia) can only be pursued after addressing the problems of medicines regulation, quality, access, pricing, financing, cost containment and generics.14 In many Asian countries, medicines sales are used as a means for revenue generation to support the delivery of health services, making promotion of rational use extremely difficult. Perhaps it is not surprising that the rational use of medicines is often forgotten or considered too hard, but it needs to be aligned with the rest of a national medicines policy if the policy is to be effective. Key challenges in the region are the absence of data to clearly define the problems and a limited workforce able to design, implement and evaluate interventions to improve medicines use.15
The WHO has advocated 12 key interventions to promote more rational use of medicines.16 While most countries have some policies that support the implementation of these interventions, these need to be addressed comprehensively and systematically. The conference heard that those countries with more comprehensive policies to support the quality use of medicines do seem to achieve increased rational use.17
Both multinational and local manufacturers need to be active participants in discussions about increasing access to medicines and ensuring quality products are available through a secure supply chain. They also need to improve policies and practices for medicines promotion, and explore new business models that recognise the need to balance profits with affordable and universal access to medicines. Important economic challenges remain for industry with differential pricing of medicines in low to middle income countries and more widespread use of pharmacoeconomic analyses to inform purchasing decisions by health insurance managers and governments. Already there is evidence, particularly from the multinational companies, of a willingness to be involved in providing affordable, universal access to medicines. The Access to Medicine Index* provides a method to monitor and evaluate the performance of the pharmaceutical industry in areas such as research and development, equitable pricing, patents and licensing, along with product donations and philanthropic activities.