One-day National Consultation on
Access to Medicines in India

Introduction

India's contemporary health system is typically characterised by a poor public health system and an unregulated and high cost private healthcare. Drugs and medicines accounts for a vital and substantial share of healthcare in India. On the other hand, health and drug policies over the years are tended to serve corporate interests rather than public health. In view of these developments, access to healthcare and in particular medicines has suffered a serious setback in recent years.

Though over the years, India has emerged as the leading supplier of affordable generic drugs in the world, the access to medicine situation in the country is not satisfactory. The World Medicines Situation Report 2004 of the World Health Organisation (WHO) says about 67% of the population does not have access to essential medicines. The need further deepens in light of the reports like National Commission on Macroeconomics and Health (NCMH), which warns that India's noncommunicable disease burden is set to increase from 1804.34 cases per 0.1 million in 2005 to 2636.31 cases per 0.1 million in 2015. The government expenditure on health is only 17.9% while private expenditure is 82.1% reports the National Health Accounts of India (NHAI).

The public health policies of the government certainly do have a bearing on the access to medicines as drugs accounts for about 70% of the total expenditure on health. There are many factors that make medicines inaccessible; the same includes inadequate support for research and development, improper pricing regulation, international obligations like TRIPS etc. The evolving global economic order has a significant impact on access to medicines and this warns us that there is a dire need for the holistic understanding of the impeding factors in the realisation of access to health.

In order to document this issue and to suggest policy correctives, Public Health Foundation of India (PHFI) and Centre for Trade and Development (Centad) are jointly planning to bring out a national level report on Access to Medicines to achieve the following objectives:

.  Map the gaps in literature as regards the access to medicines debate

.  To come up with a comprehensive study covering the entire gamut of issues as regards the access to medicines scenario in India

.  Explore the inter-linkages and map the circumstances that hamper access right from R&D stage to the recipient.

.  Come up with policy recommendations to enhance access.

.  Generate a comprehensive document which would give a strong evidentiary- and fact-based foothold for civil society concerns as regard to access.

As an initial step, a One-day National Consultation on Access to Medicines in India was organised on May 27, 2008, at India International Centre, New Delhi. The major objective of this consultation was to obtain inputs from experts drawn from civil society, academia, policymakers and practitioners in public health in the form of commissioning background papers, identifying research gaps, carrying out new research based on secondary and primary data.

Session 1: Overview of Objectives of the Consultation

The meeting started with a brief introduction of the objectives of the consultation and it was emphasised that there is a need for restructuring of the report that would try to capture all major bottlenecks with regard to access to medicines in India starting from R&D to dispensation of medicines. It would not merely be a compilation of essays but a report with semi-technical language substantiated with ground realities. The report would collect and use the existing literature along with new research to fill the existing research gap.

The discussion began with raising issues related to the need for the report. One of the consensus-based response from the floor regarding the report was that it must be comprehensive, accurate and timely. It is useful to put together in one place all the literatures that affect access to medicines and tie them up with a common thread. There is a need to identify the gaps in existing literatures that affect access to medicines. Much of the evidence is anecdotal and this needs to be backed by relevant data. Another concern was that how to define and measure 'access'. There are different definitions for 'access', but which definition we will use for the present work is to be specified. An important question from the floor was related to the target group of the report -- whether it is the policymakers, advocacy groups, activists, young research scholars, or the civil society. The report should be a suitable combination of both conventional academic research and simple countering the situation; it must befittingly respond to the argument put up by the drug companies.

Session 2: Outline of Themes and Issues

The tentative chapterisation of the Access to Medicines Report was presented, inviting suggestions for modification, if any. The emphasis was to identify the research gaps. The tentative outline that was proposed included nine chapters, viz Introduction, Drug spending in India, Drug prices, Market structure, Research and Development and TRIPS, Regulation, Role of different organisatons, Procurement issues, and Conclusions, recommendations and way forward.

The following suggestions were made by the participants on the chapterisation scheme:

.  A brief overview of the structure of the public health system in India is to be given in the first chapter. The present status of availability and affordability has to be mentioned with the support of data. Access in both the public and private sector to be addressed separately. This should cover financing, infrastructure along with human resources.

.  A detailed analysis of the Market structure is required. Analysis of Production pattern of different companies is necessary. Information on diagnostics also to be incorporated. The different layers between production-distribution and consumption of the drugs are to be explained. Questions related to the measurement of the drug requirements of the community were asked. The lack of a standardised procedure for calculating drug requirements and issues related to financial allocation for the same were discussed.

.  Participants suggested the importance of focussing on a central theme to ensure the flow of the report. Equity part should be looked into. It was pointed out that 'access to medicine' is to be located within the context of 'access to healthcare'. Otherwise this will be a repetition of previous reports.

.  Health policy of the country and drug procurement policies of different states are to be looked into. Suggestions came in to concentrate only on India. Drug policy in the country is criticised as only a pricing and licensing policy. We have to put public health in the forefront. Otherwise, it will end up in mere industry analysis.

.  There were suggestions for restructuring the chapters by collapsing the closely related themes which will ensure the flow of the report. For example, drug spending and drug pricing can be collapsed to one. Along with allopathic medicines, other possible systems of treatment should also be represented in the report. Pertaining Regulatory mechanism, the floor suggested it should be dealt with at the end of each chapter.

.  There is a need for defining the terms and concepts used in the report. A separate session or chapter on glossary was suggested to include 'what we meant by these terms'. For example, public health is not same as the public sector.

.  The floor unanimously suggested to include vaccines, blood and blood products, and medical devices along with medicines.

.  The report should include sessions for disease specific (HIV, Leprosy etc) and group specific (women, children and elderly) access to medicines. Government's role of regulation and facilitation of business is to be revisited. Closure of public sector vaccine units are to be noted. There is no effective mechanism for monitoring of production of bulk drugs in India. It was pointed out to include alternatives after analysing the merits and demerits of existing matters that can be placed in the concluding or pre-concluding chapter.

.  The floor also suggested to include case studies and conducting primary research wherever there is a need to substantiate the argument.

Session 3: Discussion of Background Papers for the Final report

The need for a rational drug policy in India was echoed throughout the discussion. Regulatory acts and role of different organisation should also be considered in the report. Concerns were raised about the unethical and intensive promotional strategies adopted by the pharmaceutical companies coupled with the declining values in the medical practice which has created a situation in which any unnecessary drug can be produced and marketed. Dilution of licensing for manufacturing and marketing drugs was discussed elaborately. Changes in the government policies with the advent of liberalisation and globalisation had its impact on the pharmaceutical sector also. The report should capture the changing nature of the industry from manufacturers to mere traders during the course of time. Much of the government's interests in this sector are inclined to promoting the industry by allowing foreign investments and profiteering by the industry. As a result what we have now is a policy that was formed to support the industry and remains silent on many important issues related to drug accessibility, quality control, rational use of medicines etc.

Much of the discussion on R&D revolved around the policy gaps and failure of the regulatory mechanism to ensure fair practices in the field. The report need to cover issues related to counter productive investments, contract manufacturing, linkages between different institutions and financing for the R&D, growth of bio-technology, role of CSIR, fake medicines, introduction of new vaccines and import of medical devices etc. Audit of the R&D area was stressed throughout the discussion.

There were suggestions from the floor to conduct primary research studies on availability and accessibility of drugs in private and public sector, incorporating interviews of key persons, including pharma sector, visiting some R&D laboratories, studies on medical audit and prescription audit etc. There was a discussion on the irrational use of diagnostic tests, and a need was expressed to consider the hidden cost of treatment as well.

It was pointed out that proper care should be taken to avoid duplication of the work.

Session 4: Other Logistical Issues

Fourth session started with the discussion on issues related to the constitution of editorial board and preparation of the report along with dissemination and advocacy plans. The responsibilities of the editorial board include developing topics, deciding upon the writers, providing guidelines for primary research and scanning through existing literatures, drafting and restructuring the entire report format. Background papers will be in technical language, but for the report, couple of people will be hired for writing it in a less technical language. The team will meet once in a month or once in 45 days and report periodically. Editorial board will look after monitoring while Centad and PHFI will take care of communication. The Chair suggested that the participants can share articles or any other information related to the subject to the group on email.

There was a strong emphasis on the need for politicisation of the issue for the benefit of the people in this country. It was decided that the report would be released before the election, latest by March. Concerns were raised to give a thrust on the impact aspects of the report which should be influencing the policymakers. The delegates also suggested to publish smaller versions of report with diagrams and charts, the result of primary research, policy briefs, writing in media etc prior to the release of the final report, so that when the final report will be released, it would be able to create pressure in the forthcoming elections. Approaching the political parties with abstracts of the report was also discussed.

Need for coordination between like-minded groups was expressed strongly in the meeting. The issue is to be expanded to other organisations working in this field, including women's groups, trade unions, right to food and right to education campaign groups . Meeting with sections of drug industry as part of coalition between all the stakeholders was also discussed, but it was rejected by majority of the participants. The meeting was concluded by setting the time for next consultation in November-December 2008 with the idea of presenting draft reports. Suggestions of reducing the consultation for half day and utilising the afternoon time for meeting with MPs and the media also came in from the floor.