Brussels -- Producing quality medicines, vaccines and diagnostic tests locally is one way low and middle-income countries can improve people's access to them, as is highlighted in a series of new reports released by the World Health Organization (WHO) in Brussels today.

"This is the first study of this type that seeks to analyse how industry, trade and health policies can work together towards shared goals to both further economic development and improve public health,." said Dr Marie-Paule Kieny, Assistant Director General for Innovation, Information, Evidence and Research at WHO. 

The study highlights the challenge governments face in balancing the availability of quality-assured medical products that meet priority public health needs with ensuring that products are acceptable and affordable. Imports of affordable medicines, often generics manufactured in India and China, are one solution but the reports highlight a growing trend towards domestic production. The authors bring together evidence from a wide range of countries that are building a viable local manufacturing industry. These include Bangladesh, Ethiopia, Jordan, and Uganda.  

Zafar Mirza from WHO's department of Public Health Innovation and Intellectual Property added, "Local production should be assessed not just on its economic feasibility. With the right financial incentives and regulation from government, local production should also be supported in a way that increases its potential to improve public health."

The reports are brought together in a summary document entitled Local production for access to medical products – developing a framework to improve public health. This framework emphasizes the importance of having a long-term vision and coherence across national policies. This means aligning policies on issues as diverse as medical regulation, industrial and investment policies, science, technology and innovation policies, intellectual property policies, health insurance policies, procurement policies, and technology transfer. It identifies five shared goals of industrial and health policy where incentives for local producers need to be matched with real improvements in access. 

The work has been supported with funding from the European Union.

Kader Arif, member of the European Parliament Working Group on Access to Medicines, Innovation and Neglected Diseases, said, "I feel there are some interesting findings in this work, particularly as the global economy shifts and it is uncertain if developing countries will still be able to rely on a supply of affordable generic medicines from the traditional sources of India and China. A lot still needs to be done at the political level to deal with the overall access-to-medicines issue, in the context of a fast evolving intellectual property rights regime. I hope local manufacturers and governments will consider this guidance and I look forward to the next stage in the development of the project, where the framework will be piloted in a number of countries to demonstrate how access to these drugs and medical equipment can be improved where they are needed most." 

Notes

This paper is the output of work commissioned and undertaken by the World Health Organization (WHO), the United Nations Conference on Trade and Development (UNCTAD), the International Centre for Trade and Sustainable Development (ICTSD) and a range of stakeholders working in the fields of public health, industrial policy and development. 

It is supported by funding from the European Union as one action under the World Health Organization Global Strategy and Plan of Action on Public Health Innovation and Intellectual Property. 

Access to medicines remains a challenge in developing countries and it is an important part of the Millennium Development Goals (MDGs).  Surveys of medicine prices and availability have shown that public sector availability of a selection of generic  medicines is less than 60% across the world.

There is a major global market distinction between the originator companies that develop new products based in the Organisation for Economic Co-operation and Development (OECD) countries that have combined annual sales of US$ 680 billion, versus the generics market value of US$120 billion. 

India and China are well known as suppliers of generic medicines and active pharmaceutical ingredients (API). For example, 80% of all donor-funded annual purchase volumes of antiretroviral (ARV) medicines in 2008 were supplied by Indian manufacturers and around 75% of API production from China and India is exported.  

Many other middle-income countries have also established a sizable pharmaceutical industry, built vaccine production capacity and are diversifying in other areas of health technologies. This trend is also growing in some low-income countries. However, the success stories of industrial development in India and China are not easy to emulate due to the size of their economies and their strategic policies, including in relation to intellectual property (IP), and in particular before and after implementation of the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS). In South Africa, for example, only 5% of the active pharmaceutical manufacture is produced locally.   

The aim of this work was to develop a framework that could bring together and guide policy-makers and others from all the relevant fields. The framework provides an entry point for supporting the local production of medicines, vaccines and diagnostics in a manner that should improve access to those medical products maximizing the potential to improve public health.

The shared goals of industrial and health policies for local production and improvement in access to medical technology

1. Strategic selection of essential medical products for local production

Focus on the medical products that are important for local public health needs, are in short supply and can be produced locally with some support. 

2. Pricing of locally-produced medical products that governments and people can afford

Strike a correct balance between affordability and economic feasibility of production. Government can support local producers of selected essential medicines through appropriate pricing policies. 

3. Strict compliance to quality standards by manufacturers and effective national regulatory authorities

No local production of medical products is desirable without quality assurance, and government incentives have to ensure strict compliance with required quality control systems in accordance with acceptable quality standards. 

4. Ensure health security – an uninterrupted supply of essential medical products

Essential medicines must be continuously available at various levels of the health system. Taking a longer-term strategic perspective, local production is one area that could contribute to greater health security and access. 

5. Innovation for development of formulations more suitable for local conditions

Innovation capacity is a critical prerequisite not only for R&D leading to new drug discovery, but also for the development of products that are incremental improvements, such as formulations that are more suitable for local conditions. 

Next steps: using the framework to promote local production for improving access to medical products 

Along with other partners, WHO plans to promote this framework in Phase 2 of the project globally, regionally and in some selected countries, especially in Africa in the context of The Pharmaceutical Manufacturing Plan for Africa. The activities are planned in the following four major groups:

1. Analysis for policy coherence

In selected countries, industry, trade and health policies will be mapped with input from the relevant policy-makers and other stakeholders in order to identify measures for improved policy coherence for local production and access to medical products. 

2. Development of global resources on local production, technology transfer and access to medical products

A web-based global repository of technical materials will be established, including a database of relevant literature. The patent status of medical technologies that are considered essential to meet high-priority national public health needs will be assessed. Links will be provided to experts and organizations providing support in this area and to technology transfer initiatives. 

3. Advocacy for the policy framework 

Briefing papers, journal articles and workshops will be used to advocate for the use and improvement of this framework approach to promote local production for improving access to medical products. 

4. Capacity building and technical assistance for local production of selected essential medical products

The real value of this framework will be in its implementation. In selected countries there is a plan to identify essential medical products that are not getting to those who need them and which can be produced locally. Areas for specific capacity building will be identified at the policy level, at the national regulatory authority level and at the company level. Local production of such products will be facilitated in close collaboration with health authorities and manufacturers. 

Websites:

- WHO Public Health Innovation and Intellectual Property: http://www.who.int/phi/en/ 

- European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases: http://www.msfaccess.org/content/european-parliament-working-group 

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