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Workshop on TRADE AND ACCESS TO MEDICINES
OCTOBER 9-12, 2007
Nalsar University of Law
Hyderabad, India

Background

Access to medicines is one of the primary components of the right to health. However, the realisation of this right is increasingly affected by national and international trade and economic policies. Although India has emerged as the leading supplier of generic drugs in the world, the World Medicines Situation Report 2004 of the World Health Organization (WHO) says about 67 per cent of the population does not have access to essential medicines. According to the National Commission on Macroeconomics and Health (NCMH), India's non-communicable 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 National Health Accounts of India (NHAI) reported that the government expenditure on health as a percentage of total expenditure on health is 17.9 per cent while private expenditure is 82.1 per cent. Drugs account for nearly 70 per cent of the expenditure on health and there has been a decline in governmental spending on health. Public spending on research and development of medicines is abysmally low.

The public health policies of the government have an important bearing on access to medicines. However in the context of the emerging international economic order, the intellectual property regime, the regulatory framework, research and development policies, the business models of pharmaceutical companies, branding and pricing strategies, domestic and international trade in medicines, etc. have a significant impact on access to medicines. Hence, there is a necessity for a holistic understanding of the factors that impede the realisation of access to medicines in the country.

To develop a shared understanding among public interest groups and individuals to ensure a favourable legal and policy regime for enhancing access to medicines in India , the Centre for Trade and Development (Centad) organised a workshop bringing together groups and individuals from across the country. The workshop on Trade and Access to Medicines was held from October 9 to 12, 2007, at the NALSAR University, Hyderabad, India .

Day 1

Inaugural Session

Ganjam Singh, Registrar, NALSAR University of Law, in his introductory remarks said the topic of the workshop is of considerable relevance because of the context in which the companies need maximum protection for their intellectual property and at the same time the public have a right to get medicines at an affordable price. In the issues related to medicine, there are other crucial issues that come up like price control, differential pricing, and compulsory licensing.

Anand Kumar Das, Project Manager, Oxfam GB, briefed on the activities of Oxfam. He said TRIPS and trade-related aspects of medicine was an important part of the Make Trade Fair Campaign launched by Oxfam. Das said the affordability of medicine is an important issue in the emerging scenario. Oxfam's For All Campaign had an element of quality healthcare to be made available to all people. He added that Oxfam is looking forward at the deliberations and what strategies the group suggests at the end of the fourth day, as Oxfam would like to take up the issues in different ways in its HIV Programme, Essential Services Campaign, and its all future work on health.

K.M. Gopakumar, Research Officer, Centad, introduced the agenda of the workshop. He said that the deliberations of the workshop will take off by looking at the meaning and content of access to medicines. Gopakumar added that there will be attempts to locating access within the health system, public spending on access to medicines and health, a brief introduction on the policy framework at the national and international level that influences access, drug promotion, issues of rational drug use, a brief on the concept on essential drugs, rational therapy, focus on drug industry, intellectual property rights (IPR) and access, sessions on regulation and how it affects access, research and development, procurement and dispensation, looking to identify policy gaps and bottlenecks on access. He said the last day of the workshop will have some success stories, how civil society shapes things, a couple of case studies, a panel on access to medicines and the role of parliamentarians.

Gopakumar said Centad is augmenting its work on access to medicines by looking at four issues related to access -- IPRs and access, regulatory framework and access, pricing and access, and industry trends and access.

Session 1

1. Meaning and Content of Access to Medicines

Nirmalya Syam of Centad explained the meaning and content of the access to medicines. He said the legal right to access to medicines is a component of the right to health, which contains a host of entitlements which defines the meaning of access to medicines as well. Nirmalya added that the accessibility of essential drugs must be without discrimination by ensuring that medicines are available within the physical reach and also affordable to all. There must be access to drug information. He said that issues of cost effectiveness should not be used as a mandate to bypass the issues of quality and thereby compromising quality standards.

Speaking on TRIPS, he said it does not lay down detailed guidelines on the ways to promote access to medicines through and IPR regime, and even the exceptions under TRIPS face the threat of erosion under constant demands for TRIPS plus standards in various international agreements. Nirmalya pointed that this is a concern that one needs to keep in mind when talking about international trading regimes facilitating the right to health and access to medicines in difference to human rights concern. He concluded by saying that civil society organisations and academics influence and shape the discourse on access to medicines in a positive way.

Floor Discussion

One of the issues raised in the session was on the nature and role of TRIPS with regard to access. It was pointed out that the human rights responsibilities are the highest obligations the states have in any multilateral agreements, including the TRIPS. In the overall balance between trade promotions and public health promotion in TRIPS, there is a balance much more in favour of trade promotion than public health concerns. There are flexibilities in TRIPS and now there is a movement for the erosion of those flexibilities. Commenting from the chair, Amitav Guha said the access to medicine has come recently from supranational bodies like UN, WHO and others. Access to medicine has emerged as a major issue. He pointed out that access impediment is coming from the industry. Another issue that came up was on the cultural and ethical acceptability of medicines. It came up that states should not push for drugs and medicines that are not culturally and ethically unacceptable even though they are effective.

Session 2

Healthcare System in India

Brinelle D' Souzo , Assistant Professor, Centre for Health and Mental Health, School of Social Work, TISS, Mumbai, narrated the evolution of India's healthcare system and where it stands now. She said the country had a planned public health services development. The two decades that followed Independence are considered as the ‘golden two decades of public health' in India, because of the expansion of primary healthcare programmes, family planning, water supply, welfare programmes, etc., and the initiation of a significant number of indigenous system of medicines and health systems. Brinelle said the next three decades saw a sharp decline in the quality of healthcare services, which acquired a technical perspective. Obsessive preoccupation with the family planning programmes led to a serious neglect of the health services needs of the poor. During the last two decades, there has been an international intervention in health by Western countries and international aid organisations. There was a movement from primary healthcare to selective primary healthcare. Since the 1990s we have health sector reforms which were broadly driven by the World Bank. Primary healthcare is reduced to the level of primary level services in reality and secondary and tertiary level sectors are the profit makers, which are promoted to the private sector. Brinelle concluded by stating that there is a lot of emphasis given to public-private partnerships, which is reducing the state's involvement in health completely.

Floor Discussions

It was observed in the session that there has been a global arrangement to derail us from reaching the goal of health for all. Health is getting more and more mystified, technicalised and it is going away from the prevailing knowledge. An important issue that came up during the discussion was on public-private partnerships. Participants said the government's capacity should be improved to deal with private partners. PPP is reducing the involvement of state in health completely and absolving the state of the responsibility of providing access to health. A comment was made that it is increasingly getting difficult to distinguish between public and private. One of the participants commented that the primary responsibility of health is of the government and there should not be any passing of the responsibility in terms of PPP. Another issue was on the lack of convergence in the public health sector among the various departments dealing with different aspects that are connected with health.

Section 3

Legal and Policy Framework on Access to Medicines

Nirmaya Syam, Centad, made an attempt to identify the organisations and other actors which have influence on people's right to access to medicines. The role of the United Nations Commission on Human Rights (UNCHR) and the World Health Organization (WHO), and also the guidelines by the Special Rapporteur Prof. Paul Hunt were looked at. Emphasis was given on the draft guidelines on pharmaceutical companies which were open to discussion. WHO's role in setting the production standards, drug research, procurement and dispensation, etc., and also the role of Intergovernmental Working Group (IGWG) were looked at.

Floor Discussions

During the discussion, the importance of demystifying the basic health indicators was raised. There was a comment that the health indicators should not be the same for all countries. Geographical, ethnic and racial differences should be taken into consideration. Participants observed that there should be regional understanding of the policy issues and indexes should be developed accordingly.

Section 4

Public Health Approach to Public Health

Gopal Dabade said the essential drug concept is especially valuable in poor resource settings as it allows people to get the best medicines with the resource available. Commenting on the model list of essential drugs of WHO, he said it is only a sort of guideline. They can be used only at the primary level, i.e., the village, district and major hospital levels. An important aspect is the amount of training that needs to be given to the person who uses these drugs. Dabade pointed out that the whole gamut of public health approaches to the concept of access to medicine is based on the problem of irrational drugs. He said the very concept of rational drug use begins as soon as the patient walks into a clinic. Dabade cited that one of the major reasons for the irrational drug use is the non-availability of the drug in proper dose and combination. Marketing strategies of drug companies and cultural factors contribute to irrational drug use. Social scientists have an important role to play in analysing the cultural aspect of the irrational drug use. Dabade called for clinical guidelines for prescribing drugs and prescription auditing to see how many of the prescriptions are rational and irrational. He said that drugs must be prescribed in generic names.

Floor Discussions

Most of the comments made in the discussions focused on the proliferation of irrational drugs. It was pointed out that the pharmaceutical companies promote various components of drugs depending on the market structure in which the firms operate. Participants stressed the need for an inbuilt mechanism to control drugs prices rather than being left to market forces. The need for a ‘national formulary' was also raised, which could help cut down the prescriptions of irrational combinations and misuse of drugs.

Section 5

Drug Promotion and Proliferation of Irrational Combinations

Amitav Guha raised the important issue of the proliferation of irrational drugs. He brought out interesting anecdotes on the drug promotional strategies of pharmaceutical companies. Guha said that many of the references on the newly-researched drugs are obscure, and sometimes conflictual and contradictory. He said the Drugs and Magic Remedies (Objectionable Advertisements) Act (1954) is silent on ways to prevent unethical marketing. The code of ethics of the Organisation of Pharmaceutical Producers of India (OPPI) also has ambiguities and is non-specific. The policy conclusions of the Guha were direct. He called for the formulation and implementation of ethical code by the government, change in legislation and creating an exclusive ministry to deal with all aspects of medicines, production control, screening out of all medicines and weeding of irrationals, central and strict control of clinical trials, central legislation of licenses and screening of all promotional activities of the pharmaceutical companies by developing protocols to qualify promotional materials, and also educating doctors.

Floor Discussions

One of the significant issues that came up during the discussions was on the off-level use of medicines. It was pointed out that no protocols are followed in such cases. Irrational drugs are very dangerous. Participants were critical of the role of the government with regard to regulations on drugs.

Section 6

Health and Drug Expenditure

Shaktivel Selvaraj presented the magnitude and pattern of the health expenditure in the country and tried to locate drug expenditure in the overall framework. He said only one-fourth of the total expenditure on health comes from public expenditure. Regarding insurance, he said it is hardly there. Social insurance is basically CGHS and ESIs and both together come to around 2.5 per cent. It was pointed out that the major part of the health expenditure was on drugs alone. Selvaraj said people in rural areas spend around 5.7 per cent and in the urban areas 4.8 per cent of the total expenditure on health.

Floor Discussions

Participants commented on the cost and spending involved on drugs as part of the health expenditure. A comment was made on the necessity to improve the public healthcare system with considerable monitoring. There were discussions on institutional support, i.e., by way of insurance on large scale. The necessity for gearing up the whole system was also raised. It was pointed out that the very system that is supposed to cure illness is bringing illness by pushing people into poverty.

Day 2

Session 1

Pharmaceutical Industry: An Overview

Shakthivel Selvaraj made an extensive survey of the pharmaceutical industry and pointed out that the normal dimensions of consumer choice do not exist in this particular sector. He said the MNCs claim of involving extensive R&D expenditure on drugs is highly misleading, as this figure includes significant expenses that are tax deductable and unrealistic scenarios of risk. R&D expenditures are primarily for contract research and clinical trials in particular rather than for any basic research or infectious diseases. Selvaraj added that the profitability of the pharmaceutical industry is one of the highest compared to all other industries. He explained developments like the ‘brand aging' in which old drugs are being dumped and new ones, which basically meant ‘old wine in new bottle', are introduced at a rapid pace. Selvaraj also raised the issue ‘fix-dose combinations', which are mostly irrational therapies, and said it is really a matter of great concern.

Floor Discussions

An important issue that was raised during the discussion was on the issue of data on drugs and the problem of access to data by the public. It was pointed out that the data were protected to serve the interests of the pharmaceutical companies. Another issue discussed was on the lack of regulations on irrational drugs. It was observed that the industry, chemists, physicians, consumers and the government are responsible for the proliferation of irrationals. Regulations for the pharmaceutical industry were pointed out as a prime concern. Participants stressed the need for public interest litigation and educating the public.

Session 2

Drug Pricing and Access

S. Sreenivasan, Locost, said that drug pricing and access to drugs should be analysed in the context of the tremendous public health crisis. Affordability of drug is very important. Quoting the National Sample Survey Organisation (NSSO) studies, he said healthcare expenditure is the second most common reason for rural indebtedness. Srinivasan said the heath systems are decaying because of the increasing privitisation, irrational and unscientific drugs, etc. He explained the vast anomalies that exist over pricing where profit margins can be up to 4000 per cent. He added that different brands of the same drug sell at vastly different prices and most drugs are out of government price regulation in India. Srinivasan said that competition has not brought down drug prices because of the information asymmetry. He said that in heath and pharmaceutical sector there should be price regulation. Regarding patent, he said, we need alternative models for encouraging and rewarding innovation. Srinivasan said that there should not be any patent for any essential drug for the kind of therapeutic classes and kind of diseases there exists in this country.

Floor Discussion

A question was raised whether compulsory license can be issued only on epidemic situation or whether pricing too can be a reason. It was pointed out that since access to medicines to secure public health is provided for in the TRIPS Agreement, pricing also can be a reason for compulsory licensing. Another issue raised was on the role of insurance companies in regulating prices. It was pointed out that the insurance companies do not want the government to regulate prices, but they want themselves to call the shots. It was also observed during the discussions that the best way forward on pricing of drugs is to bring all essential drugs under price control.

Session 3

Intellectual Property Rights and Access to Medicines

Amit Sen Gupta in his presentation looked at the major concerns that are emerging today on the issue of IPRs and its ability and otherwise to promote innovation, to promote access, and also to promote research. He said IPRs are state-mandated monopoly and have now become protection for corporates rather than individual innovators. Gupta said, in the pharmaceutical sector, we have a situation where a handful of pharmaceutical companies who have access to IPRs decide what kind of drug should be developed. The attempt is to look at the next ‘blockbuster'. On the TRIPS Agreement, he said it was to keep the Indian, Chinese and Brazilian companies out of the markets in developed countries and it is not about free trade. He said there is profiteering in the pharmaceutical industry, the wrong kind of research being done and inhibition on research. Many patents are taken out to stop others from inventing rather than to protect one's own invention. It leads to the stifling of the domestic industry. The battle over IPRs is now shifting out of the WTO and the TRIPS Agreement to Free Trade Agreements (FTAs) and bilateral agreements. Gupta said it is not sufficient today to look at the TRIPS Agreement and its implementation, as the battle has shifted to other arenas like WIPO.

Floor Discussion

One issue that came up during the discussion was what stopped Indian companies from investing in product development. It was pointed out that the TRIPS Agreement was the prime reason that restrained Indian companies. Another issue raised was on TRIPS plus standards. It was observed that the standards vary from sector to sector on the basis of the flexibilities provided in the TRIPS like the parallel imports, data protection, compulsory licensing, etc. Public funding on R&D was another important issue discussed.

Session 4

Data Exclusivity and Implications for Access to Medicines

Leena Menghaney, MSF, said the whole system of intellectual property is based on exclusive rights. The exclusive rights can stop another legal entity from exploiting intellectual property. She added that data exclusivity came up in the context of TRIPS, but it is something more than the TRIPS. Leena warned against the intensive lobbying of the US pharmaceutical companies for data exclusivity in India. She said data exclusivity is a way of imposing intellectual property and preventing affordable generic drugs by stopping the drug regulatory authorities from approving generic drugs. It almost works like a patent, which leaves us from any alternatives and it delays competitions and prevents other companies from selling an equivalent drug. Leena said it is important to look at data exclusivity from the point of access to medicines. She added that post-grant opposition is much more difficult than a pre-grant opposition, and it is better to opt for pre-grant opposition in terms of data exclusivity. She concluded her presentation by stressing that it is difficult to give data exclusivity under the Indian Drugs and Cosmetics Act, and if we go for data exclusivity, it will have an impact on access to generics.

Floor Discussions

A question was raised on data exclusivity on clinical trials. It was pointed out that there should not be any data exclusivity on clinical trials as safety and efficacy have already been established. It will only be a replication of the costs involved, if clinical trials are done again and again. Another comment was made that duplicating a clinical trial is an ethical issue. Data exclusivity also has human rights implications. It was also discussed on the need for providing incentives for the innovator outside the patenting system.

Session 5

Indian Patent Law and Access to Medicines

K.M. Gopakumar in his presentation gave a brief on the evolution of India's patent law, the various amendments that have been made, the pre-grant and post-grant facility, and the significance of the Novartis case. Gopakumar said there are many gaps in the government-use and compulsory licensing provisions. There is a need to strengthen India's institutions and systems and make proper use of flexibilities given in the TRIPS Agreement. On the question of whether the introduction of patent affecting access to medicines, he said as far as old drugs are concerned, patents are not going to make an impact on access. However, patents will have its impact in terms of new drugs in small segments, i.e. on very particular area of cancer, hepatitis, etc. Gopakumar concluded by stating that there are gaps in the law and gaps in the implementation of law in addition to institutional gaps. He warned against laws getting harmonised through references by lawyers on case laws from the US, the UK and Europe.

Floor Discussions

Some of the comments raised in the session were on the greater costs involved in sourcing information from the patent office in India. Participants commented that it is difficult even to identify the heads under which patent applications are filed. Another question was on the issue of post-grant opposition. Since there is a requirement for an interested party for filing opposition, it was observed that the post-grant opposition can be a time-taking process.

Day 3

Session 1

Regulation and Access

K.V. Sharma in his presentation gave a detailed analysis of the various rules and regulations that regulate and control drugs and other pharmaceutical products. Tracing the history of drug regulation, he said it all began immediately after the Second World War due to the increasing demand of drugs and the rise in production of cheaper and inferior drugs to compete with the imported drugs. Sharma explained in detail the various provisions of the Drugs and Cosmetics Act (1940), Narcotic Drugs and Psychotropic Substances Act (1985), Medicinal and Toilet Preparations Excise Duty Act (1955), Drugs Price Control Order (1955) and the Essential Commodities Act (ECA), Drugs and Magic Remedies (Objectionable Advertisements) Act (1954) and Pharmacy Act (passed in 1948 and amended in 1959, 1976, 1982, 1984, 1986), Drugs and Cosmetics Amendment Bill (2007), etc.

Floor Discussions

A question was raised regarding the mechanisms in place to regulate access to drugs. It was pointed out that in case of access, if any manufacturer, using his dominant position, tries to prevent any other manufacturer, from manufacturing the same medicine then, competition commissioners can take action. Another question was whether marketing of drugs can be considered as an industry. It was observed that according to the Industrial Dispute Act, which was amended, sales promotion is considered as an industry, and therefore, all sales promotion activity should come under industry. An observation was made that there is no facilitative environment for access in spite of the sheer number of laws. Another observation was made on the problems and the cumbersome process in litigation faced in preventing quacks.

Session 2

Pharmaceutical R&D and Access

Dinesh Abrol in his presentation explained how the transition from a process patent regime to a product patent has been effected in India. He said technology and knowledge have become a market good. There has been considerable decline in productivity in pharmaceuticals. Abrol said there were problems of alignment of innovation and access adding that though innovation is taking place, it is not directed on the diseases of the poor. The focus has shifted in favour of lifestyle diseases. Patent has become the new currency. There is no disclosure in research. He cited instances of the decline in public-funded research and problems of coordination and integration. Abrol concluded his presentation by stating that the whole patenting system was created in order to help finance capital, the private venture capital.

Floor Discussions

Participants remarked that there is a lot of restructuring taking pace at global level. It was pointed out that there is a need to create open access drug companies or drug management board by an international treaty. It should be funded through commitments from both developed and developing countries. LDCs should be exempted. It was observed that no single actor is capable of producing drugs and it has become a distributed capability. A question was raised on how much money on average is spent by the domestic industry and R&D for Type 3 diseases. It was pointed out that it is 5 to 7 per cent of the sales and worldwide the pattern is 12 to13 per cent, but there are companies that are higher to 18-20 per cent.

Session 3

Drug Procurement Dispensation and Access

S. Srinivasan, Locost, focused on drug procurement, drug policies, and also provided a tentative critique of some drug policies which have been circulated. He brought some interesting anecdotes on procurement while explaining the different modes of drug procurement. The Tamil Nadu and Delhi models of pooled public procurement (PPP) have been explained in detail. He said the PPP has substantial advantages by reducing drug prices and also ensuring quality. He added that the essential drug list is very important and the one formulated by the government should be implemented and only those drugs, mentioned in the list should be available, except for rare cases. Srinivasan concluded by presenting a comparative pricing of various drugs in the PPP model.

Floor Discussions

A question was raised on what prevented other states to model drug procurement on the pooled public procurement model of Tamil Nadu. It was pointed out that it depends on political and bureaucratic will because of the various interests involved. Another issue was on the criteria for procurement and the protocols followed. It was observed that there is a lack of standardised and need-based assessment on procurement. It was mainly done on the basis of a guess work like a percentage of previous year's procurement, etc.

Session 4

Advocacy Case Studies

1. National Working Group on Patent Laws

Amit Sen Gupta explained how the National Working Group on Patent Laws was formed and how the group was able to put together considerable amount of expertise. The Federation of Medical Representatives in India (FMRI), the Kerala Sasthra Sahitya Parisad (KSSP) and a host of voluntary organisations joined together to form the All India Drug Action Network (AIDAN). He also pictured how industry supported initially and then backed out.

Floor Discussions

An issue was raised on whether India's stand on patent should have been different. It was observed that the country's position should have been different. When India joined the WTO and signed the TRIPS, the other countries which were supporting India's position also joined as if there is no point in opposition to WTO and TRIPS. Another issue was raised on the three-phased amendment done on patent. It was commented that India's drug industry benefited considerably as a result of shifting to product patent in 2005. Another observation was made that even if we stay with TRIPS, implementation of patent law is neither technical nor legal, it is political.

2. Pre-grant Opposition

Loon Gangte, Delhi Network of Positive People, speaking on pre-grant opposition said the generic companies were successful in pulling down the prices of branded drugs. He quoted the example of Triomune which initially costed Rs. 480,194 and how it got reduced to Rs. 6072. Since patenting of drugs will lead to the stopping of production of generic drugs, it poses great threat to people living with HIV/AIDS and other diseases. Loon gave a list of drugs such as Combvir, Atazanavir, Kaletra and Gleevec in which the pre-grant opposition has been effectively used.

3. One Year World Win Campaign

Kajol Bharadwaj presented the campaign against patent for Glivac, which is a crucial anti-cancer drug, considered a wonder drug, and useful for chronic leukemia. Indian company NACO was producing it. Novartis has the patent for this drug in most countries, except for India. Kajol said the case was regarding what happens when a company has a monopoly. The success of the campaign was important because it was about every drug for every other disease for which applications were pending in the Mail Box. Kajol said the Glivac campaign was one year of consistent media and legislative campaign. It went from a national campaign with reverberations at international level.

4. Pharmaceutical Policy 2002

S. Srinivasan, Locost, presented a detailed critique of the Pharmaceutical Policy 2002. He said it will reduce the basket of drugs to be in price control to about 25 from 74. It identifies bulk drugs to be under price control from the sales figures of formulations. Whereas most formulations are sold in combinations, it uses only sales of only single ingredient formulations to determine whether drugs will be out of price control or not. Srinivasan said the policy has no consideration as to the essentiality of the drug or its impact on poor. He said all essential drugs should be under price control. He concluded by pointing that the government has to intervene to protect public health because of the market failure in pharmaceutical sector.

5. PILS on Hazardous Substances

Gopal Dabade, Drug Action Forum, said the public interest litigations (PILs) are unique to India. He explained the evolution of PIL on drugs and pubic hearings that were held in different parts of the country. PILs have been effective in banning a number of drugs. Cohesiveness, involvement of various groups and media are important for success. PILs have helped to increase awareness and in developing an attitude change towards drugs. They could not remove all problems related to drugs. It is important to put the onus on government for weeding out irrational drugs. It is the government's responsibility to protect public health. Policy interventions along with PILs will help to serve a lot. Dabade also presented in detail the historical opposition to EP4 and neurobin.

Floor Discussions

An issue was raised on the possibility for a PIL to force the government for better regulation of the pharmaceutical and health sector. It was observed that the possibility cannot be ruled out, but one needs to present models of effective and successful mechanisms that are in place in other countries and highlighting the problems and failures in the existing system in the country. A comment was made that the proposed central drugs authority will help for more regulations. It was also observed that political and media advocacy are essential.

Day 4

Session 1

Access to Medicines and the Role of Parliamentarians

Chair: K.M. Gopakumar

Karan Singh Yadav, Member of Parliament, in his brief at the workshop highlighted instances of enormous rise in price of drugs, how the issue was raised in parliament and how it was taken up by the media, the way the ‘Parliamentarian's Forum on Access to medicines' was formed and the modalities of its working. Yadav cited instances of profiteering in the drug sector and how the network works. On the role of parliamentarians, he said they do have a role to play and to shift discussions on access to medicines it is important to have suggestions and recommendations from organisations and groups which are focusing on issues on medicines. Yadav concluded by stating that it is important to take care of the accessibility and affordability issues on drugs.

Suresh Kurup, Member of Parliament, in his presentation said it is difficult to raise a mass movement regarding the prices of medicines owing to the typical nature of the issue. He said a highly awareness campaign, especially among the members of parliament, legislatures, public health workers, and media, is essential. Kurup said there is near-absence of discussions on issues related to drugs and medicines in parliament. Easy and ready availability of drugs is part of the fundamental right. The policy of the government is gradually shifting from consumer-friendly to industry friendly. There should be a balance between the two. People-friendly amendments like the Section 3d were made possible through the intervention of a section of parliamentarians. There needs to be considerable pressure on the government and considerable vigilance is required. He said it is important to educate the parliamentarians and keep them informed. Kurup concluded by stating that an active and focused campaign to weed out all unnecessary drugs from the market is required.

Floor Discussions

A question was raised whether parliament can scrutinise the Draft Pharmaceutical Policy which is currently with the Group of Ministers (GoM). It was pointed out that the Parliamentary Standing Committee on Health can deliberate on it. The committee can also call all interested parties for a hearing in the committee. Another issue was raised on the need for prioritising R&D on drugs. It was observed that a full-fledge department, in addition to the existing departments of health and AYUSH, to focus entirely on research is coming up. Another question was raised on the ways and means to bring the attention of parliamentarians to issues of health. It was pointed out that active groups should brief parliamentarians on issues for more intense lobbying in parliament.

Agenda

Backgrounder

List of Participants

Presentation on Trade and Barriers to Access to Medicines

 
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