Sourirajan Srinivasan, LOCOST (Low Cost Standard Therapeutics)

Lead Author: Sourirajan Srinivasan
Organization: Low Cost Standard Therapeutics (LOCOST)
Country: India

Abstract

Access to medicine world over has been highly compromised by many factors including the following:
1. Patents and TRIPS Plus trends
2. High Prices of Pharmaceuticals old and new
3. Lack of Access to Technology, both formulations and APIs and Machinery
This brief paper deals with all the above 3 factors and makes some suggestions to overcome these obstacles to access.

Submission

Access to medicine world over has been highly compromised by many factors including the following:
1. Patents and TRIPS Plus trends
2. High Prices of Pharmaceuticals old and new
3. Lack of Access to Technology, both formulations and APIs and Machinery
This brief paper deals with all the above 3 factors.
1. Patents and TRIPS Plus Trends

1.1 Patents and TRIPS Plus Trends like evergreening and data exclusivity provisions have become a regular feature in bilateral treaties among member states with tremendous asymmetry in GDP and per capita incomes (that is among poor and rich countries or “weak” and “strong” countries). The UN would need to come out with a model Free trade Agreement that suggests to the “weaker” member states as to how not to draft FTAs that will not be in the long interests of such member states. A center constituted by the UNDP or suitable UN agency must provide expert advice that developing countries and LDCs can call upon. Such a center must also provide advice and expertise as to how to draft model patent laws that are consistent with TRIPS and that that does not yield to TRIPS Plus trends and pressures from developed member states. Experience of countries like India on Section 3 d that call for higher standards of patentability, pre-grant, post-grant oppositions, enabling provisions like Compulsory Licences, etc., must be shared with an idea of incorporation into national patent laws of LDCs and developing countries. Assistance and training will also have to be provided to such LDCs as necessary for assessing and evaluating patent applications.

1.2 TRIPS itself must be reviewed as it was supposed to be and some explicit provisions spelling out useful features that can be adopted by member nations must be spelt out and be part of the revised TRIPS (eg., Compulsory Licence Provisions and when it can be invoked and how to take measures against evergreening, etc).

1.3 There is a great need to rethink and reevaluate the basic assumptions of patents as intellectual property rights. There is no clear cut evidence to date that product patents promote innovation especially in the area of pharmaceuticals. If the inventor is to be rewarded, other mechanisms including prize finds must be explored. Product Patents on pharmaceuticals thereafter needs to be abolished or at worst minimized to 7 years as they are anticompetitive and especially in the area of medicines are against the welfare of the human race. A commission be appointed again to consolidate the research findings on patents and innovation and suggest suitable alternatives for encouraging innovation.

1.4 Voluntary licensing must be recognized as a means to promote IPR and monopoly by other means. Member states, especially LDCs, must be discouraged to go in for anticompetitive voluntary licensing arrangements with patent holders.


2. High Prices of Pharmaceuticals Old and New

2.1 Recent trends in the US have seen exorbitant high price increases of older drugs and especially of those that are out of patent. This reveals if anything the worst side of a profit-oriented industry that is pharma and that places profits above people. It is the right of people to have access to affordable medicines. This must be re emphasized in international covenants.

2.2 An information pool/portal that is accessible by all as to sources of low priced quality medicines must be put up with advice as to how to order. Member nations must be encouraged to import on behalf of their governments by sourcing such lower price medicines, or create suitable mechanisms thereof, in the face of extraordinary greed by certain pharma corporations causing extraordinary price hikes of useful drugs leading to life and death crisis in several cases.

2.3 Such a portal will also reveal the true costs of medicines. A Pharmacoeconomics Commission with international authority must be constituted to research on the costs of patented drugs even as it provides transparent information and calculations as to what is the real cost of out of patented formulations. Latter the exercise can be extended to cover APIs and specific technologies used in production and quality control and assurance.

2.4 Pharmaceutical pricing is a human rights issue. Prices of medicines determine the haves and have-nots in health care access. Routine judicial commissions by appropriate UN bodies with powers to pronounce which of such prices are human rights violations by companies must be constituted and with powers to act on private corporations. There is no reason why if UN can legitimize action including collective isolation/boycott including counter offensives on private armed groups/militia in certain areas of the world, something equivalent cannot be thought of with respect to corporate in pharmaceutical sector that violate human rights by unaffordable and exploitative pricing of medicines, patented or otherwise.

2.5 The UN must constitute its own body for arbitral procedures preferably under the umbrella of the International Court of Justice. Private arbitration between nations must be declared against international law especially when the issue is of medicines and human rights. The WTO can continue to arbitrate on routine trade issues even as it must refuse to recognize TRIPS Plus invocations in FTAs and declare them as illegal.



3. Lack of Technology for formulations and APIs and Machinery
3.1 Pharma production has been made into a rocket science which it is not. Nevertheless there is scope for a center (or centers) for dissemination and demystification of pharma production technology internationally and preferably located in a developing country like India. Such a center will train or organize the training of countries interested in the formulation production to begin with. Later it may help in training of technology for APIs and production machinery. Emphasis must be on appropriate technology that is simple and affordable and doable.
3.2 The function of such centers will also be to help plan technology transfers to LDCs and plan for backward integration of technological skills, and products.
3.3 Countries like Bangladesh (who have LDC status till 2033) must be particularly encouraged to move towards self-reliance and self-sufficiency in technology for formulations and APIs.

4. Conclusion
This note has been written on behalf of LOCOST (Low Cost Standard Therapeutics) based out of Vadodara, India. LOCOST, established 1984, is a civil society organisation that manufactures generic formulations and markets them at low prices for over 120 medicines. It has experience of manufacturing and production and technology transfer to Bangladesh and has been a leader in India in promoting awareness and public advocacy of over pricing of medicines in India. Its efforts – in conjunction with other civil society partners like the All-India Drug Action Network (AIDAN) – through public interest litigation (PIL) in the Supreme Court of India has resulted in all drugs in the National List of Essential Drugs to be put under price control in India.