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16th December
Up goes IP, down comes public interest: the evil Giant wheel of WTO+ FTA)
Himakshi, Ishupal, Azamat, Gurpreet, Ganesh, Naveen
As the 4th Global Congress on IP moves into its final day, here’s a quick look at some of the interesting insights on trade, intellectual property, and right to health.
20 years have passed since the most comprehensive and far reaching multilateral agreement covering a multitude of issues under the overarching theme of trade came into existence. Intellectual Property was one of these issues. After several years which saw highly contested negotiations, global rules about knowledge and innovation production under the Agreement on Trade Related Intellectual Property Rights (TRIPS Agreement) were agreed to.
This new era of free-trade agreements threatens the very core of the consensus achieved under TRIPS. Since the developed countries were unable to achieve their agenda in a multi-lateral forum, they shifted the strategy by negotiating the same issues through bilateral agreements. Several sessions in the Congress focused on sharing insights on those presently being negotiated, and their implications on public interest including access to medicines. The larger goal seems to be raising the IP protection standards across some countries through bilateral and then bring that back to WTO for renegotiating TRIPS to the same standards.
The key agreements being negotiated include Trans-Pacific Partnership (TPP), Transatlantic Trade and Investment Partnership (TTIP), Regional Cooperation and Economic Partnership (RCEP), and EU-Free Trade Agreements (EU-FTA). Of these the TPP negotiations were concluded in November, and now needs to be ratified by the Parliaments in the signatory countries. The others are still being negotiated. However, based on the final TPP text and the leaked chapters of other agreements, there seem to be a move towards enforcing TRIPS+ standards.
The panel discussion titled ‘Are Trade Negotiations Injurious to Your Health?’ provided an interesting space to unpack the specific provisions within these agreements that are extremely problematic and pose a serious threat to public interest on a number of issues. The speakers also highlighted the ramifications of these provisions on access to health.
Some of the most discussed provisions were on data exclusivity that extend product patent terms from 5yrs to 8yrs. This would translate to market exclusivity, especially for biologics, delaying entry of generic medicines, i.e. biosimilars. The impact of this would be devastating, especially for countries like Vietnam where presently the government is able to provide ARVs to 68% of people living with HIV. If the country ratifies the TPP, then this number is likely to come down to 30% or less, given that the price of the drugs will go up but the budgetary allocation will probably be the same if not reduced due to the financial climate. The developed countries will also have serious implications. A speaker shared findings of her research from Australia where the tax-payer funded Pharmaceutical Benefits Scheme would make substantial savings from the entry of biosimilars, thus increasing their ability to cover more people.
The free trade agreements are also bringing in clauses that reduce patent eligibility requirements. While the argument is that they will promote innovation, speakers shared concerns that the kind of innovation promoted would be small, insignificant changes to existing drugs, dis-incentivizing actual innovation. Additionally, this would delay competition, particularly the entry of generics.
Another critical matter at the centre of many deliberations was the Investor State Dispute Settlement provisions (ISDS). ISDS provisions enable private investors to challenge the government in case of not adhering to certain provisions especially those related to investment. The inclusion of intellectual property within the definition of investment within some of these free trade agreements creates a effective possibility of strong enforcement of these intellectual property rights by private investors. Same kind of apprehensions was also discussed in panel titled Trade Agreement, Copyright, Internet and Enforcement Provisions in relation to field of copyrights.
India has a high stake in these global developments, whether it is directly participating in the agreements or is implicated by market restrictions imposed in other ASEAN countries. In this context, it becomes important to look at the national trends and developments in intellectual property. This theme was the focus of a very interesting panel titled ‘India’s National Intellectual Property Rights Policy (IPR): The Way Forward’ chaired by WTO Counselor Jayashree Watal. The draft IPR policy prepared recently by the Indian govt. was the central point of discussion and several speakers shared their critique on it. A key challenge raised was the lack of focus on innovations, especially in the field of neglected diseases. There was also a recommendation that the policy should be linked with the other industrial policies for coherence. A common remark was that the IPR policy had no regard for various factors including affordability, accountability and transparency. The policy doesn’t address implementation challenges like lack of coordination between agencies.
The discussions on challenges raised by the free-trade agreements inevitably led brainstorming ways in which these can be addressed. An interesting and recurring tension was the lack of clarity about the ways and strategies of pushing back and contesting against such kinds of global rules which has so many drastic implications. One view was on focusing upon finding and locating internal flexibilities and positive provisions within these agreements. Another one was one understanding the whole picture and emphasizing on completely alternate ways beyond these systems rather than playing the game of developing countries of periodic racheting up of intellectual property standard through different ways.
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17th December
Up goes IP, down comes public interest: the vicious whirlpool of International IP Law Making
Himakshi, Ishupal, Azamat, Gurpreet, Ganesh, Naveen
The most interesting session on Day 3 was a panel discussion titled ‘Regional/National Implications of International IP Law Making’. Nirmalya Syam talked about the future of WIPO and the development agenda which is the basis of the negotiation. It was during the 2004 General Assembly meeting of the WIPO when an informal proposal presented by Argentina and Brazil for establishing a development agenda was first circulated for discussion. This proposal basically questioned prioritization of promotion of intellectual property rights within WIPO and through its activities and argued for incorporation of development concerns specifically referring to WIPO as a specialized UN agency having mandate as well as responsibility to “take into account the broader development-related commitments and resolutions of the UN system as a whole. This proposal recieved immediate support from many developing countries forming the Group of Friends of Development. After much deliberations, the Development Agenda was officially adopted, three years later, in 2007. The DA in its final form contains forty five points or recommendations, agreed upon from the various proposals submitted by member nations. These forty five recommendations have been organized in six following categories : Technical Assistance and Capacity Building; Norm-Setting, Flexibilities, Public Policy and the Public Domain ; Technology Transfer, Information and Communication Technology and Access to Knowledge; Assessments, Evaluation and Impact Studies; Cluster E: Institutional Matters including Mandate and Governance; Other Issues (Enforcement of IPRs, overall balancing of interestes according to Art. 7 of the TRIPS. The key issues related to the the development agenda which were pointed out are. Despite the broad and far reaching recomendations the interpretation by WIPO has been narrow. The understanding of TRIPS flexibilities as employed by the WIPO includes deviation from principles of TRIPS which go beyond the actual obligations (TRIPS plus provisions). This is contrary to the aims of the Development Agenda. Furthermore, the technical assistance and capacity building activties conducted by the WIPO for the supposed benefit of the developing countries is narrowly focused on better enforcement of intellectual property rights rather than helping with their particular developmental needs. Lastly, there is no progress within norms setting activities related to protection of the public domain.
The next presenter Sangeeta Godbole spoke of her experience as a negotiator for the Indian govt. on the EU-FTA Trade & Goods track. She shared that in most negotiations there is space for arriving at some consensus, at least on the agenda if not on operational terms and conditions. However, when it comes to IP negotiations, there is a stark divergence between India’s stance and the stance demanded of it by EU. The modus operandi often seems akin to a badgering than a negotiation. Another challenge faced by the negotiators is lack of alternative proposals on IP that often hamper the bargaining process. Her recommendations centered on looking beyond TRIPS, or at a ‘TRIPS improved’ agreement that is pro-development agenda. Christine from the American University echoed Sangeeta’s suggestion, citing findings from her research on IP treaties signed in early 1900s. She pointed out how there is a proliferation of IP treaties and gave the example of Chile which has signed close to 100 treaties on IP till date. The takeaway from her presentation was also that TRIPS is not final and absolute. There can be and should be a push for the next agreement on IP that better balances user rights with public interest. Taking on from this theme of the need for alternatives, Feroz Ali, presented a proposal on reimagining TRIPS as an access regime. He started with pointing out that even though there is a provision in TRIPS for review, no renegotiation has taken place, bringing a stasis in international IP law making. As a result countries are resorting to bilateral agreements and changes within national law that respond better to their national IP contexts. In this backdrop, he proposed relooking TRIPS as an access regime which would include high standards of patentability, corollary standards for import and export, as well as strong use of compulsory licensing provisions, especially contemporaneous CLs for manufacturing and import. For this regime to work, countries with manufacturing capacity would play the role of enablers while countries that are strong markets for the generics would be allies with relaxed regimes.
A running theme in this session was also to relook at the trade negotiation processes. Speakers focused on the need for unity among developing countries for bringing to the table a consistent narrative and argument on the alternative to TRIPS+. Another strategy would be to accommodate for the divergence in IP needs of the developing countries as the contexts are varied and thus one-size-fits-all agenda for negotiation may not always work. In these scenarios, a model text reflecting national IP needs would be a much-needed asset for the negotiators.
The panel on reforming negotiation processes was another interesting session. The key takeaways were similar to other discussions. There are challenges in manner the trade negotiations are carried in secretive manner. Every policy issue became trade problem and IP policy is important in that aspect. Trade Agreement becoming less inclusive and process of trade negotiation is closed and opaque these are the very important concerns raised by Electronic Frontier Foundation. It has been noted that the secrecy of the trade negotiation process is default due to following factors-
- Weaker position of Civil Society.
- Academia with limited access to negotiation materials and facts supporting government positions.
- Legislators with no access to even the text being negotiated.
Civil Society can do mobilisation on ground through knowing and informing who is involved in negotiation process /Mapping their networks/ links previous experiences can keep check on right person/ institution taking part in countries negotiation process. Need to connect with local journalists and whistle a blower with keeping anonymity is need of hour. Rather than influencing a international organizations which is difficult to mold; it’s better to target the local governments of democratic countries or key players in government. Dynamics of any negotiation process is to reach the agreement; everyone has to gain something reaching the consensus.
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16th December
TRIPS Implementation
Mayank, Biplab, Shabnam, Archana, Ashwathy, Godwin, Prachi
Implementation of TRIPS flexibilities session laid emphasis on the experience of developing countries like Thailand, Argentina, Brazil, India and China in implementing the ‘TRIPS flexibilities’.
A common consensus that emerged from all the presentations in the panel discussion was that stronger IPR protection in pharmaceutical sector did not lead to increased innovation through greater foreign direct investment. TRIPS was also unable to boost R&D in newer drugs in developing countries. Thailand did not see an increase in FDI inflows after it amended its Patent law in 1992. Also, issuing 7 compulsory licences till 2007 did not significantly affect the FDI inflows in Thailand. Concerns were also raised regarding unequal distribution of R&D expenditure in pharmaceutical industry where 78% of the R&D expenditure occurred in OECD countries alone.
Concerns were raised about the high prices and lack of availability of medicines in Latin American nations. Prices of some essential drugs ranged from 3-45 times the International Reference Prices. Use of health safeguards (TRIPS flexibilities) was advocated by the speakers to provide access to medicines.
Exceptions and Flexibilities were first raised in Berne Convention(1967). TRIPS took a few leaves out of the Bern Convention and brought in the provision of Article13 which says “Members shall confine limitations and exceptions to the exclusive rights to certain SPECIAL CASES which do not conflict with a NORMAL EXPLOITATION of work don’t UNNECESSARILY PREJUDICE the legitimate interest of the right holder.” The process of screening through 3ST (3 STEP TEST) is generating lot of confusions. It’s being said to take the 3ST in its literal meaning. There are some misconceptions like (a)public interest must outweigh the right holder’s interest. (b) even a small fall in the right holder’s benefit due to exceptions is not welcome. Universalization of 3ST hasn’t gone smoothly and it has been badly misinterpreted. The Article necessitates the introduction of compulsory license. However 3ST can be applied only to those exceptions which has been mandated by international law. It is to be estimated who benefits from 3ST actually. 3ST can be effectively practised to improve the economic interest of the member countries. 3ST is expanding from the interest of the right holders to interest of public health. It is also included in TRIPS ARTICLE-13, WCT ARTICLE(10)(1)(2), BEINJING ARTICLE-13(2), so ubiquity has become a problem. So as a whole the 3ST entails lot of complexities,which the right holders are trying to take advantage of and diminish the public interest per se. Whereas many people are more inclined to public interest and few are advocating for balance between IPR and Public Interest.
In the context of China and implementation of TRIPS, in 2001 China had to make the hard choice to take part in the global market by signing the TRIPS agreement and hence formulate Intellectual Property Laws. However they have succeeded in using intellectual property to protect their knowledge based economy. In 2012 the Central Committee of the CPC acknowledged the need to protect and “utilise” intellectual property. The speakers also conceded that the scenario is different on resource based economies.
Interestingly their patent laws give special emphasis on protecting the end user. They have thus made good progress towards striking a balance between IP and public interest. China now has special courts dealing with IP and they intend to introduce a total of 10 such courts with trans-provincial jurisdiction. They also discussed how companies had to keep their FRANDS obligations and how the value of these were determined. A very incisive discussion on trademark litigations followed. WIPO reports state that for another subsequent year China came first in the sheer number of patents. An interesting point made was that low quality patents hamper public interest, and so stronger quality checking measures were needed.
Taking in to consideration the implementation of TRIPS in LDCs, what can be construed is that LDCs have the privilege of not complying with provisions of TRIPS as compared to that of other Signatories of TRIPS. But the non-compliance to some provisions and the flexibility of the provisions should not be taken for granted by the LDCs. The LDCs should strive hard to come out from the tag of LDCs in the transition period and make the TRIPS applicable to them in all aspects to ensure free trade, technology transfer and other benefits that ensure further growth and development of the countries. Few examples of implementation of TRIPS in countries like Cambodia, Uganda etc gives an impression that even though the LDCs are given exceptions in complying with the TRIPS, some countries are keen in applying the principles in their governance. Sometimes, it is also because of the international pressures that they undergo. Still the problems persist as to some incoherencies between the different sectors of the country itself. The LDCs also face challenges in the form of misguidance from international institutions like WIPO in the name providing technical assistance. When discussions are made on LDCs, the focus is being lied on the diseases like Hepatitis, Tuberculosis etc whereas no mention about cardio-Vascular-Diseases and Diabetes don’t find a place even though most number of deaths are due to those diseases. From a different perspective, it can also be stated that the some countries fear losing the LDC status as they will lose the privileges they enjoy as being a LDC.
The IPR policies in India face a unilateral TRIPS policy. IPR has been one area in the India- US bilateral ties that both have been at loggerheads. The American firms, especially the pharmaceutical companies had been extremely critical about India having a lax IPR and patent laws discriminating them against domestic firms. The youth group raised questions and recommendations about the topics. The discussions could also give a clear picture about the IPR policy in India.
A Key message that could be drawn was that a patent free world would be a better world. Medicines Sans Frontiers organised an open side event which was designed as interactive session on patent opposition database, a web-based session of information sharing and collaboration. A patent less world becomes necessary because commercial goals assume predominance over public wellbeing. Better access to medicines can be ensured through a virtuous cycle through patent opposition, leading to voluntary license and compulsory license which in turn help parallel imports and finally patentability gets questioned. The challenges for the civil society include: lack of access to technical knowledge and IP activism is a highly skilled and specialised area of work. The session highlighted the work of MSF as they have created a dataset of opposition to different patenting of drugs in different parts of the world.
Moreover, there is a need to understand various terminologies related to ‘innovation’ so as to make understanding about the issue clearer. Rather than debating on whether an innovation should be patented and to what extent, focusing on incentives ‘openness’ provides, might help propagate this idea. Right to access and Right to innovation are both important and demand a balanced approach to be taken towards them. These rights should be seen pertaining to ‘individuals’ rather than nations or industries. In case of compulsory licensing, availability and affordability of medicines should be looked at rather than how it will affect pharmaceutical industry.
Manufacturers have sufficient incentives to invest in and develop new technology other than patenting the innovation. Case might be that (as in case of PIV medicines),patents give very little benefit to manufacturers and does not protect them from imitators which is actually done by regulatory and licensing mechanisms.
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17th December
TRIPS Implemented: Efficacy is still a question!
Shabnam, Biplab, Archana, Prachi, Mayank, Godwin, Ashwathy
The 1970s were about pushing back the idea that social creativity can be commodified. The 1980s were about negotiating in the adversary’s ground in rearguard, focused on creating loopholes. The developing countries failed to utilise these loopholes because of lack of political will. In fact while victory was claimed after every round of talks, there was in reality a ceding of ground each time. India has now reached a stage where we don’t even pretend that we’re putting up much of a fight. There is nothing new about the unilateral action by the United States which is really what the bilateral treaties are all about. It is time to turn the game around and take the offensive by opening new agendas and through direct trade relations instead of tariff relations.
There was a time when one Indian generic pharmaceutical company could change the face of the industry. But the instance of voluntary licensing in the Hepatitis C drugs means that the generic industry are now aligning themselves with global pharma, and we will have to rethink our strategies to protect public health. We also need to question whether poor implementation is affecting public interest in a bad way.
Pre grant open prosecution of patents is turning out to be an effective tool against low quality patents and this option can be explored in other countries. A study in drug trials in India was presented. The number of biologics being clinically tried in India has gone up in a span of ten years from 3% to 20%. However these are often priced so high that the same drugs which have been tested on them. One out of five drugs tested in India between 2005-2010 have not even been patented in India.
The Delhi Network of Positive People’s presentation of their work among HIV positive patients was particularly impressive. Their dedicated struggle opposing the NACO and the Ministry of Health for stock outs, protesting the change in the patent law in 2005, demonstrations against the RCEP with Japan is heartening. Their organisational skills and their endeavour to create an ambience in which everyone could be comfortable within their group is examplary.
The IPR protection has been observed to be reflected in various countries like South Africa, Australia, Indonesia, Brazil in ways which necessitates the urge to rethink and reform the IP policies over these countries. South Africa seems to be one of the most suffered countries because of the TRIPS and TRIPS PLUS agreements. The primary problem appearing in South Africa is that there is no good enough patent examining scopes. The criteria are often not fulfilled and more often not conspicuous one which leads to pharmaceutical companies to take advantage of the loopholes and gain unjust patents. In similar to South Africa, in Australia the major issues with IPR implementation is that it has not invited much investment as the so called myth promises to be. The quality of patent laws is too said to be of poor quality and it’s not just simple enough to interpret. Whereas in Indonesia the Patent reform laws are just budding in government level. There had been many movements from the civil society on demand of proper patent laws to facilitate easy access to medicines especially the ARV and HEP-C medicines. It is nice to see the issue of patent laws are now being talked over in Indonesian parliament and active endeavour on the government’s part to involve the public in general. In country like Brazil the IP reforms are being reconsidered to respect the principles of public health i.e universality, sustainability, and access. As a part of reforms all most all of these countries are unanimous on the fact that CL and parallel importation is required to be rigorously practised. It’s necessary to put up proper patent criteria and proper patent examination system along with enabling pre and post grant opposition provisions. The public interest is to be prioritised at the same time putting up balance as much possible with IPR. The media houses of the respective countries needs to be addressed and the governments should take initiative to save the public health system and ensure access to medicine regarding common health problems which calls for better adoption of the TRIPS agreements which according to some countries should get abolished if possible.
India also being a member state to the TRIPs agreement brought changes in its IPRs laws. The preceding years after becoming the signatory to the TRIPs, the country has seen many new IPR enactments. With globalization, liberalization and privatization, the ambit of IPR has grown multi-fold and its importance has amplified, having a profound impact on commercial interests. In spite the implementation of TRIPs, the working of patent system appears to be poor in the Country. There still persists a need to have some judicial reforms with respect to grant of patent injunctions in India. Stricter statues is still a requirement as concerned to avoidance of frivolous patent applications. It can be stated that at some point of time or the other, India forgets the ‘Trade’ in TRIPs and gave importance only to IP. Data Exclusivity is another concern that still persists. In fact, there should not be any data exclusivity. However, it is a appreciable decision that India has made in the case of Beyer V. UOI, to grant compulsory license. The country and the people can proudly say that rather than being a developed or developing country, it is a Technologically Proficient country, irrespective of existence of flaws in the policies of the Country.
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16th December
Access to Medicines is a Human Right!
Deepak, Ishu, Pallavi, Amitabh, Ankur, Bijoylakshmi, Sanjeeta and Lalremuata
One of the most pressing issues in 21st century is the lack of availability of essential medicines to poor patients in underdeveloped and developing countries. The problem is attributed to the existing Intellectual Property Rights (IPR) regimes, which are not aligned with the goals of health and wellbeing under Millennium Development Goals (MDGs). This issue was widely discussed during the second day of the Global Congress on Intellectual Property Rights (IPR) and Access to Medicine 2015, which began with a panel discussion on Human Rights and Medicines: Opportunities and Threats. The panel was presided over by Justice Michael Kirby. He broke a news that United Nations (UN) General Secretary Ban-Ki-Moon has constituted a High Level Technical Panel, with an objective to overcome the prevailing incoherence in the IPR polices, which was one of the underlying causes of the failure of health goals under MDGs. The IPR regime has not only posed challenges for HIV/AIDS, but also to many other tropical and neglected diseases in countries of Asia, Africa and Latin America. Under the IPR regime, issues related with the accessibility of medicines could not be addressed with the help of market mechanisms. In case of HIV/AIDS, the cost of antiretroviral drug was approximately $10,000 under IP regime. However, with the intervention of a generic drug producer Cipla, the price of drug was brought down to $295 in 2001 and further to $67 by 2010. Thus, the drug development by generic companies provides a viable option to the patients to fight life threatening diseases. Similar is the case of Hepatitis C, as so far 246 drugs have been tested and only 1 has proved to be effective in curing the disease. This particular drug is developed by Gilead, which holds patent right over the drugs. The patent hold by the drug company has a corresponding impact on price of the drug (which is approximately $40,000).
According to Alma Ata declaration in 1978, health for all was envisioned as the goal to be achieved by 2000. Post 15 years, we haven’t been able to achieve it. So far, the HIV movement has been used as a battering ram to fight for other causes. Currently, the patients are fighting a lonely battle as their concerns are not aligned with the larger campaign objectives. During disease, the patient is in a vulnerable state with a sole aim to live and thus, falls prey to marketing gimmicks of pharmaceutical companies. The TRIPS regime and patent laws has further added to this vulnerability as there is non-compliance with human rights standards in its implementation. The question is, “Are patents delivering its objectives for which they are meant to?” Patents failed to deliver the stated objectives. The moral question is that it should be put into debate to the developed world. There is a strong need to make it a public battle. The generic pharmaceutical industry is under real threat. There is no counterweight to large pharma. The generic industry doesn’t have the support of the government. The way to overcome with the existing fragmentation is to come up with an analysis on how IPR is undermining the health of the individuals. Thus, there is a need of integration in the IP movement.
In 2008, the World Health Organization (WHO) published the final report of the Commission on Social Determinants of Health, entitled “Closing the Gap in a Generation—Health Equity through Action on the Social Determinants of Health.” It was evident from the report that social injustice is killing people on a grand scale and therefore, there is a need for a global action to achieve equity in health and access to medicines. Most of the international agencies, philanthropic foundations and donor countries provided funds to tackle the menace of lack of availability of essential medicines, however in recent times they have seemed to be withdrawing, as diseases like HIV/AIDS are no more attractive to them. The other major challenge is the rising need of second, third and fourth line of antiretroviral drugs by the patients, who are currently surviving on the first line drug. Again the lack of availability of essential drugs is the gross violation of human right to health.
Accountability of the global institutions viz. WHO, WIPO and WTO is required. WHO is currently not engaging in multi-sectoral action and around 80% of its donations are from various trans-national corporations having vested interests. The contribution of member states has gradually declined. WIPO has no clear aims and objective focusing on IP and development. It has failed to deliver as a coordinating agency for IP as developing and least developing countries are still struggling with stringent biased IPR which makes immense obstacle to get universal access to medicines. WTO on the other hand, is affected by the trade across the world and is currently being funded majorly by China. All these organizations are by and large run by developed countries and their interests where the agenda is set by the member states but in reality influenced by the few. The need of the hour is to convey in simple terms the key message of IP, so that its pros and cons are understood clearly at the community level. Community should be mobilized for a global movement on IP.
The sessions at Global Congress 2015 were quite informative, interesting and interactive; however, we as a group felt that voices from the grassroot were under represented. There seemed to be a gap between the policy makers and people working at the community level.
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17th December
The Global Congress on IP and Public Interest – Perspectives!
Ankur, Tushita, Lalremruata, Pallavi, Ishu, Deepak, Amitabh, Sanjeeta
Various issues were debated in today’s congress and this blog piece is a reflection of that!
Indigenous Traditional Knowledge and Geographical Indicators
Indigenous communities have been vulnerable when it comes to the protection of IP. There was no IP law before Geographical Indications of Goods (Registration and Protection) Act in 2013 in Bangladesh and their IP policy is not effective as since it is majorly controlled by local businessmen. The legal policy and the issues of traditional knowledge mention the importance of Geographical Indication (GI) and GI Tag for the protection of traditional knowledge and economic upliftment of the rural communities. The way that we treat indigenous peoples in our countries is like apartheid. The companies and countries are manipulating the GI such as Darjeeling Tea in India, which was registered GI in India but some companies in Japan misuse the name of the place to make Divine Darjeeling Tea. In order to protect the GI registration, all the stakeholders need to create awareness regarding the genuine products so that the real owners will get benefit. The government needs to realize that helping the indigenous and marginalized community to get GI registration as a protection of their social and cultural life is essential rather than thinking of it as business, trade and development. There is a need to prevent bio-piracy of our traditional medicines and other valuable products.
Making the Right to Medicines a Reality: An Innovative Approach
At the same time, it was debated that access to medicines should also be considered a human right. However, there remained an important question: how could this right actually be made a reality? One interesting example that was discussed in a number of sessions on the final day of the Congress was that of DNDi (the Drugs for Neglected Diseases initiative). DNDi is a not-for-profit drug development agency that is focused on meeting patient needs without relying on patents. Their goal is to make medicines for neglected diseases affordable and accessible to people who need it most. DNDi starts its work on a disease by first consulting with governments and communities to identify patient needs. Next, its team conducts a review of existing literature and pharmaceutical databases to determine existing pre-clinical research that could be helpful in the development of new therapies. When DNDi finds interesting compounds in public or private databases, the agency negotiates to get access to the existing intellectual property, in some cases purchasing the existing intellectual property using philanthropy to cover costs. Finally, DNDi begins developing the drug and carry out clinical trials to bring the drug to market.
The strength of this approach by DNDi is two-fold. First, by conducting in-depth analysis of existing research on neglected diseases, DNDi is able to utilize existing research and identify compounds that may be very promising in treating neglected diseases but were never brought to market because pharmaceutical companies did not see a large market from which to earn a profit. Second, by negotiating to ensure that patents are not placed on or exercised for the drugs they develop, DNDi is able to develop drugs at a price that is much more affordable in those countries where neglected diseases are most prevalent.
Open licensing
With few or no restrictions, when any document, text, songs, other materials are shared, redistributed and become easily accessible to the public, then that particular work has an open license. This can be very useful in colleges and institutions because this will help students to access study materials without hassle. But do we talk about copyright issues? Are copyright issues even considered while making the intellectual property accessible on the internet to be availed by all? At the Global Congress, two speakers from Austria shared their ideas on copyright implications. They focused on teachers’ perspectives and students perspectives. The teachers of Austria are of the view that open licensing provides access to teaching material, editing and online distribution. They are also of the view that it allows them to have digital reproduction at a large scale. The students/ learners are of the view that open licensing definitely helps them create digital copies for learning purposes and this also helps them to have a collaborative learning with each other. In Austria, the classes of schools are seen as public and copyright implications are very low here. It definitely provides free access of information that is beneficial for the students but how do we ensure that the author’s copyright is maintained? The speakers wanted us to reflect upon the idea of copyright issues of intellectual property, especially in colleges and schools. This raises some vital questions as to what steps universities take ensuring that the intellectual property of authors is protected?
A renowned American Anthropologist, Margaret Mead used to say that children must be taught ‘how to think, not what to think’! A very inspiring thought indeed. Education in its true sense means freedom to study any and everything and letting the children/ students choose their niche areas. But are we as a world providing fair chance to all? Do we provide enough access to students across class and cultures to get hold of study materials? Are we doing enough to ensure that the professors across countries write their books and not depend on the books by few developed nations?
The context of Latin America was discussed in terms of how the country’s education sector works when it comes to availability of textbooks for students and writing of books by local authors. Textbooks are really expensive in Latin America and about 60% of yearly salary of people is spent on buying textbooks. Latin America has not come up with a solution yet. But the students have- photocopy of materials! There aren’t enough books for them already because most books are by authors of foreign countries and they are not available in abundance. There are very few books by local authors therefore the students do not have much to bank on. The professors are not used to writing books which doesn’t mean that they are not capable of writing textbooks. Only about 50% of the students use studying materials that includes photocopied materials. Most study from their class notes itself. And the rest do not have any access to the materials. Photocopying of materials is very common across schools and colleges in Latin America, but this also raises questions of copyright implications. Are there any legal solutions? LATIN (Latin American Textbooks Initiative) is an organization working extensively in this area and have come with a solution to this problem. Collaborative writing strategies can be used for textbooks productions. These will be licensed therefore solving the problem of copyright and will be easier for the professors. There must be Technological Platforms which may comprise a library, writing platform and a social platform where students and professors can interact. LATIN has successfully used these methods and in the year 2014, they had textbooks written by 1500 professors. Also, they are conducting surveys to find out whether these new textbooks are good enough to replace the traditional textbooks.
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16th December
IP Law & Policy Making with Special Reference to A2M
Astha, Lokesh, Neelanjan, Pradeep, Somalatha, Sulok and Sushma
Today’s visit to the Global Intellectual Property Congress 2015 was a new experience for all of us. Our focus was on the Intellectual Property (IP) policy making with special reference to access to medicine. Our discussions are in the wake of a national IP Policy and significant national and international developments.
IP policies need to focus on the involvement of IP in investments and its role in public health. The effects of aspects such as bilateral investments and compulsory licensing must also be taken into consideration while forming such policies. The overall relation between the IP policy, competition and the competitive environment among the industries must be taken into account while formulating an IP policy.
It seems that right now there is no clear vision about the IP policy. To achieve the powerful, public interest oriented IP policy, some targeted parameters such as transparency, predictability, competitiveness and rational account are required. The current IP policies have failed on a rational account. However, even if such a policy is formulated, there is a chance that it will fail on the ground of regulatory consent, because IP is a reward system and it is market driven. Governments do not drive IP, rather it is driven by the market. With regard to the question of access to medicine and public interest, a conspicuous lacunae in the IP policy is the disregard for neglected disease. IP is an instrument for national competitiveness and there is a direct link between the IP and the industrial policy. At present the patent landscaping and communication sector in India have the above mentioned aspects which are necessary for a powerful IP policy implementation.
There is a necessity to establish a proper link between IP and innovation and economic growth. Patents and trade secretes play an impactful role and help in economic growth.
Right now IP is treated as an end, however, it must be treated as a means to an end. The formulation of a specific Indian IP study program and a clear vision as to whether it is market driven or society driven is the need of the hour. A careful consideration of trade secrets, trademarks, and copyright is needed. At present there is no consideration about the role of IP policy in agriculture. The relation between IP and innovation must focus in agriculture sector too.
The general consensus among panelists seems to be that the IP Policy cannot not be completely abolished, rather, a reconciliation between IP laws and the right to health is the goal. Justice Kirby in his address pointed out that such a reconciliation was already underway in the international arena with TRIPS flexibilities coming into being. However, such flexibilities are not working and hence a High Level Panel has been commissioned by the Secretary General of the UN to iron out the ‘policy incoherence’ with regard to IP and access to medicines. It is apparent from the discussions that the IP policies of various countries are not as important an incentivising mechanism as the pharmaceutical market make them out to be. This is an interesting point which points to what one of the aims of this Congress should be – to identify a perfect balance between IP policies and the access to medicines, safeguarding both the rights of inventors to just rewards as well as the right of the public to health.
Another point raised was that voluntary licensing is causing a huge divide at the global level regarding the voluntary licensing amongst activists working for access to medicine. The TRIPS agreement no doubt is flexible but these flexibilities have not worked much in the favor of the developing countries. There are drugs in the market which have been patented especially in the case of tuberculosis but have not been licensed. Furthermore, compulsory licensing has not been favored by the private players as it decreases their control over the license with the generic manufacturing company. It is hoped that the deliberations of the High Level Committee will help in reaching some consensus, with regard to the IP policy, particularly whether to conserve the existing patent law or to modify it.
The need of the hour is a robust and flexible IP policy which can cater to the needs of different interest groups. In the discussions a number of defects in the present IP policy were identified. Firstly it was identified that specialized IP courts are no final solution to IP related issues. Further the tone and timing of the policy was wrong – in the sense that there was no balance between the law and its enforcement and a policy should ideally be formed before the legislation and not after it. Our policy was made many decades after the enactment of the IP legislation. The policy also lacked in predictability and rational outcome. Predictability in the sense that it tried to integrate the vast number of variables in one single policy document which is quite impossible and does not offer much of a solution rather than providing only for more and more studies. Rational Outcome in the sense that by going into too much details the policy restricts the space for judicial creativity. Also, the policy should choose principles which are neutral and not pro or anti IP.
Another primary issue identified was the lack of integration between various groups working towards the common goal of ensuring access to medicine for all. So there is a need to integrate and synergize various efforts. The need to increase people participation in such efforts was also stressed upon. Increased government intervention in the market is very essential to ensure access to medicine especially in countries like India. Right to health cannot be fully ensured by providing pills alone. What we need is a comprehensive solution to the problem.
Development is a major concern of any IP policy and how development is construed under the policy will determine the overall effectiveness of the policy. Development is not merely confined to economic growth. In the Indian perspective development has to be defined taking into consideration the needs and aspirations of the society. Indian society is characterized by diverse interests and an ideal IP policy should cater to these diverse interests.
Thus, in conclusion, the present IP policy must be balanced with the right to health. Abolition of the IP policy is not a solution. Today’s session were really interesting and thought-provoking. But some of us who were not familiar with basic IP concepts found it difficult to follow some discussions. Overall the sessions were very informative.
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17th December
IP Law and Policy Making with special reference to the case of A2M
Astha, Lokesh, Nilanjan Pradeep, Somalatha, Sulok and Sushma
One of the new fields having a direct impact on access to medicine is Biologics. Little has been explored as to the relationship between IP, access to medicine and biologics. Other closely related issues are that of public funded research institutions and clinical trials.
In the larger context of Innovation Policy it is necessary that some direction in this regard is given. One of the issues is as to what the policy of India relating to public funded research institutions should be. Two types of public funded research institutions were identified. One doing incremental innovations whereas other doing non-incremental innovations. So the question was whether the focus should be on non-incremental innovation which would result in patenting and huge profits or should it be on non-incremental innovations and contribute to the larger interests of advancement of science and technology?
It seems that a policy should go for the latter. The further question is as to how to manage patents if so obtained. This is in light of the fact that most of the public funded research institutions in India take only a few patents and those also are not licensed. Further interesting questions were asked such as should clinical trials in India, which is a major component of working of the patent especially in pharmaceutical sector, be conducted by public institutions? The suggestion made was to the effect that creation of a State sponsored platform for conducting of clinical trials could incentivize such institutions to take more patents.
Any IP model should ensure access and innovation. So any policy should be directed to achievement of these. The field of biologics is creating many new challenges like as biologics mostly involves biological materials and very complex molecules it becomes hard for proving bio-equivalence or bio-similarity. It is to be seen that the following policy questions are very critical as far as access to medicine is concerned. A policy which incentivizes public research institutions especially in the area of biologics can go a long way in ensuring access to health.
Standardization is another critical area to be focused on by the IP policy. Today we see hundreds of standards in any product/commodity. Standardization has a crucial role in ensuring right to health and access to medicines. So the holistic question is as to should India create its own standards or should we run behind international standards. The panel expressed the need to focus more on domestic standards. This would enable medicines and drugs to be in compliance with the standard and thus highly reduces cost. So we must decide as to how India should view standards and is there need to make changes to them in compliance with international standards or should we make our own?
Another point made was how licensing and regulation and access are an essential part of the market. The concept of Plain Packaging and its role and effect in the market and how it could be one of the alternatives for selling of certain goods was explained in great details. From a pure policy perspective a country like India must consider whether we must provide policy directions for plain packaging. This is a crucial question when it comes to tobacco and other harmful products. Many other countries like Australia are taking efforts in this regard. Suggestions were made to the effect that the government should regulate promotional effects of brands without jeopardizing these companies’ rights.
India is often regarded as the pharmacy of the South and we know more than ever that it is under threat. We further see changes in approach of pharmaceutical companies in the late 20th century where Indian companies resisted against the foreign pharma domination and now in the early 21st century where we see the pharmaceutical companies queuing before the foreign giants for licenses. This is a dangerous trend and so a sound policy must be made which gives conditions favourable to strengthening of the pharmaceutical sector in India which is essential for ensuring access to poor people of not only India but also of other developing and least developed countries.
Yet another common thread running through this seminar regarding the present IPR Policy was that it is ineffective and must be modified. The root cause of the problem was identified to be the exploitation of developing and least developed countries by the developed nations of the world. Interesting suggestions as to how to change this policy were proposed throughout the seminar with speakers drawing parallels to the recent agreement to control climate change. The point made was that if the world could come together to ensure that the health of our planet and the environment is safeguarded, a similar such meeting to modify or even reverse TRIPS is definitely a possibility. Learning from past mistakes was emphasized upon with special reference to the Inter-American Convention of Trademarks and Unfair Competition. It will be wise for the global community to study the numerous forgotten bilateral treaties that still exist today and use these to bypass the unfavourable TRIPS provisions. A viable suggestion to strengthen IP protection as well as the prevention of counterfeiting is stricter enforcement at the export point rather than the current practice of import screening. This proposition has statutory backing under Article 51 of the TRIPS and if properly implemented, will save Indian manpower and expenditure, not to mention mitigating the miscellaneous problems which arise with regard to disposal of forfeited goods.
The panelists at various sessions did not base their lectures on mere conjecture, rather they produced studies and statistics obtained by them from the field. A few results which were presented were particularly interesting and informative, specifically the studies conducted on the efficiency of S.3(d) in the Indian Patent Act and whether it is actually fulfilling the objectives of the Act. A study by Dr. Bhaven Sampat and his team revealed that the wile in other countries the secondary patent grant rate was much lower than the primary patent grant rate, in India, both the primary and secondary grant rates were almost the same. The bleak conclusion drawn from this study was that S. 3(d), in spite of its lofty ideals was not being implemented as was hoped. On the other hand Dr. Feroz Ali’s presentation on pre-grant oppositions being a step towards open prosecution of patents was much more heartening. The various successful pre-grant oppositions that have been filed resulting in rejection, abandonment or withdrawal of the opposed patent under S. 3(d) have been numerous. Thus, it may be implied that the reason S. 3(d) has not been directly relied on in case of post-grant opposition rejections as was pointed out in Dr. Sampat’s study could be that it is already being made full use of in the pre-grant opposition stage, and successful use at that.
In the midst of these scholarly discussions, the plight of the social workers and other people in direct contact with, or victims of, the patent regime which is not allowing them access to medicine was put forth as a stark reality. This congress, apart from providing a platform for academic theories to flourish must also make sure that implementation of the conclusions of their discussions take place.
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16th December
R&D, Innovation and Openness
Madhur, Eira, Piyush, Anu, Bilal & Nalini
Using Copyright for Collaborative Innovation
This session ‘Using Copyright for Collaborative Innovation’ aimed at free and transparent access to information through various collaborative efforts. Asaf Bartow from Wikimedia foundation discussed about various wikis and wikidata which is a collaboratively edited knowledge base as a source of common data types working under Creative Commons (CC) licenses for free distribution. Owing to the fact that that anyone can contribute the information, he emphasised on group communication mechanisms which allows the system of contributions to be edited apart from the content itself. He also discussed about the copyfraud i.e. false copyright claims and threats which Wikimedia foundation have faced such as from National ecurity Agency (NSA). Next talk was about “Pratham”, a non-governmental organisation to provide quality education to the millions of disadvantaged children in India. Books from Pratham have been published in various Indian languages. Pratham also has Storyweaver, an innovative plateform for children to read and enjoy stories their mother tongue. Finally, Sunil Adapa discussed about “FreedomBox”, a project to develop personal servers having free software which could protect privacy of the users running on Debian operating system.
It is clear that asymmetry of our society stems from the greed and secrecy of certain firms. After this discussion one can promote a harmonious system by developing the open access to knowledge through different innovative approaches. This Session could be more interesting if there were some interactive multimedia presentations especially in FreedomBox presentation.
Human Rights and Medicines: Opportunities and Threats:
The Campaign for Access to Essential Medicines is an international campaign started by Medecins Sans Frontieres (MSF) to increase the availability of essential medicines in developing countries. MSF often has difficulties treating patients because the medicines required are too expensive or are no longer produced. Sometimes, the only drugs available are highly toxic or ineffective, and they often have to resort to inadequate testing methods to diagnose patients.
Moving further towards today’s session Former High Court Justice and Sydney Law School alumnus the Honorable Michael Kirby AC CMG has been appointed by United Nations Secretary General to a high-level panel on health technology, innovation and access. The new Panel deals with trade, public health, human rights, and legal issues associated with access to treatment. Main task of panel is to make recommendations to the Secretary-General about how to improve the affordability and accessibility of essential medicines and how to improve incentives for the development of new vaccines, medicines and diagnostics. Panel’s focused area is set of health-related targets that fall under Goal 3 of the Sustainable Development Goals. These include the target of achieving universal access to “quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all”. As non-communicable diseases assume a higher profile in low- and middle-income countries, access to these drugs will also bring new challenges. Kirby stressed that there was a need to value the human right to life-saving medicines.
Further we have Pisey Ly she has been involved in women’s rights networks for many years thus working on the most urgent social problems Cambodian women face today. She focused on the area of sex workers, where she said that if government pays special attention towards them and listen to their views, it can lead to better anti trafficking policies. She even said that if we can’t give them a better life at least we can send them to rehabilitation for care and protection of health. It’s simple as no matter how far you go – go basic. Lastly, she also paid tribute to Andrew Hunter was the leading activist towards sex workers in Cambodia.
Rethinking the Future of Openness
The session titled ‘Rethinking the Future of Openness’ was an intense discussion on the growing legal formalism of the idea of openness. The panelists raised pertinent issues on how the idea of openness cherished under the Creative Commons license is being itself reduced to another element in the formal legal structure, thus destroying the very objective they sought to protect. An interesting observation made in this regard was by Lawrence Liang wherein he distinguished genteel openness from carnal openness, thereby seeking a more fierce form of support to open access. The panel drew attention to the fact that diverse movements are working towards creation of a more open knowledge system. However, these movements need to be more coordinated in their efforts to ensure that they don’t end up with conflicting demands, rendering their efforts futile. Youth participants in GCIP can take a cue from this observation and work towards harmonization of demands for openness. Alex Torkowski defended the faithfulness of the CC licensing system to openness by differentiating the idea of accessibility from ownership, stating that a CC license allows much greater accessibility to works while attributing the work to its creator. This, in his opinion, added muscle to the openness movement. Voices of dissent went further to state that a CC license is only a form of open license and not the only one available. It has over-shadowed alternative licenses, resulting in the destruction of the multiplicity of licenses available for an open sharing network.
Twenty years of TRIPS: flexibilities in practice or broken promises?
The session which questioned the very objective of TRIPS was chaired by Karyn Kaplan. Post TRIPS experiences of various countries, particularly the LDCs and Developing, were shared by Inthira Ramabhai, Loreno Di Giano, Nirmaly Syam and Fransisco Rossi. Focus was on the changes made by different countries to their existing patent laws owing to TRIPS compliance and the difference it made on their economy. Discussions concentrated on the promises (increased innovation, growing inflow of FDI and Transfer of Technology) which TRIPS made to its member countries in return for stronger IP protection. The most important information unraveled during the session was that there was no empirical evidence to prove that IP had possitive corelation with innovation, inflow of FDI and technology transfer. On the contrary empirical evidences shows that the relation has been on the reverse gear in case of “innovation” as the number new chemical entities invented after TRIPS was seen to be in a sharp decline. TRIPS has indeed been a broken promise as the promised land seems to be too far as the LDCs are not in a economic and technological possitions to use the flexibilities and the developing nations are being threatened by the international pressure in case of using them.
WTO, WHO and WIPO: Global Institutions Operating in Public Interest
Session about WTO, WHO and WIPO consisted of a panel of Nirmalya Syam, German Velazquez, Biswaji Dhar, Jayshree Watal, and Manisha Shridhar . WHO, WTO and WIPO are global institutions protecting various interests of people. From that perspective one can argue that UN leaders have initiated not so much reform of our as their neoliberal restructuring. The fundamental problem is that WHO has lost control over its budget. Currently less than 20% of its budget comes regularly from assessed member states contributions. It also discussed that WIPO General Agreement adopted 45 recommendations about public interest in 2007. Recommendations are placed in 6 clusters. 19 recommendations are for immediate implementation. In the present scenerio where the three global institutions function independently and protect the interest of different stake holders, harmonious co-existence of the IP rights with Human rights is required.
Public need instead of private greed: open knowledge innovation, a new approach for biomedical research and development
The session “public need instead of private greed: open knowledge innovation, a new approach for biomedical research and development” discuss how the approaches towards access to medicines has improved since 1996. The cost of antiretroviral medicines has come down from 12,000$/year to less than 100$/year per patient. The access to medicines initiative which initially depends on the Government’s will or charity has morphed into people’s right with the active support from United Nations, Ministries and various NGOs. The session also discuss various models which helps to innovate new medicines in a cost effect way. The development of new medicines for neglected tropical diseases or poor people’s disease does not attract much attention from the pharmaceutical firms because of the higher cost and unaffordability of new medicines. The open innovative approaches like Drugs for Neglected Disease initiative (DNDi) and P3 (Pull, Pool and Push) provides sustainable and cost effective solutions to innovate new medicines for the developing countries.
The public interest should be a prime objective while making policies towards research and development. The innovative approaches which are least confined to the fetters of intellectual property rights should also encouraged towards research and development related to biomedical and pharmaceutical sectors.
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17th December
R&D, Innovation & Openness
Madhur, Eira, Piyush, Anu, Bilal & Nalini
Reimaging Innovation system: The ‘commons’ approach to research:
The Session “Reimaging Innovation system: The ‘commons’ approach to research” discussed the nature of innovation with corresponding emphasis on pharmaceutical research. The innovation could be divided into incremental and non-incremental innovations based on the outcome and risk that is inherent with the innovation. The significant leap in the knowledge primarily occurs through the non-incremental innovations which usually come in unexpected form while the incremental innovation does augment the knowledge but the outcome is expected. The pharmaceutical sector’s interest principally lies towards the incremental innovations because of the low risk involved in the innovation. The significant increment in “me too” drugs reflects the power that lies in the incremental innovations. The non-incremental innovations which are mostly public funded and favoured by the academician draws less attractions from the pharmaceutical sectors because of the high risk and unexpected outcome related to the innovations. The technologies and medicines developed by the pharmaceutical sector by incremental innovations depend significantly on the knowledge generated by the non-incremental innovations. The restructuring of research especially in the pharmaceutical sector requires a balance between incremental and non-incremental innovations for sustainable development of medicines.
Overcoming Barriers to Access to Medicine:
This session saw Chitra Arvind and the Lawyer’s Collective enlighten the participants on the nuances of conduction of prior art search when an application for patent registration is filed. A patent application has twin dimensions to it, which an application must keep in mind while submission of the application. International applications can be files from the date of filing of first application in all PCT member nations. Breaking a patent is a quintessential element of ensuring that only truly novel drugs receive patent protection and the regime is not used by big pharmaceutical companies to further their vested interests. She identified several interesting sources of finding of prior art on an invention which ranged from ancient texts like the Vedas to online resources of patent offices across the globe. A more thorough research would include checking conference proceedings, publications in scientific journals, encyclopedias, company disclosures, advertisements, etc. The databases are primarily divided into patent literature and non-patent literature, both of which need to be exhaustively analysed to find evidence to break a patent. A person seeking to oppose a patent application needs to substantiate his claim with sufficient evidence gathered from various sources.
India Pharmacy of the world: For now?
The session which analysed the current possition of Indian Pharmacy in comparison to its possition prior to the amendments of 2005 was chaired by Sharmila Mary Joseph. Concerns regarding the future of Indian pharmaceutical companies which is currently the hope of third world nations were raised by S.P.Shukla, Amit Sengupta, Bhaven Sampath, Feroz Ali, Arjun Bawja and Loon Gante. The session began by the analysis of the impacts created by TRIPS over the Indian Patent Law and consequently the Indian generic industry. The Patent Act whose vision was on welfare and rejection of the commodification of social creativities was replaced by more protection to private rights through TRIPS. With the change in the international legal framework the public policy of India also seems to have changed. Indian generic companies, once a competitor of MNCs have now transformed into recepient of their voluntary licenses. The session analyzed change in the public policy of government as the reason for it. Support to domestic industries have been on the decline since TRIPS.
The role of 3(d) was also analyzed which interestingly showed some conflicting signs. While the empirical datas submitted by Mr. Bhavan Sampath showed that the rejection of patents on the ground of section 3(d) was low the datas on pre grant opposition analyzed by Mr. Feroz Ali showed that section 3(d) was an important factor in rejecting incremental innovations during pre grant opposition stages. The session also questioned the common notion that India is a tough place of patents. Datas proved that contrary to the common notion the secondary applications granted in India were almost similar to the number of primary applications granted (45% :46%). But in the case of other major countries except South Africa but including United States the grant of secondary applications were much less in number when compared to the primary applications. Pre grant opposition was identified as an effective tool in attacking unwanted patents because it is the only procedure that allows for checking the validity of patents even before granting it. It was identified that pre grant opposition had very high success rate, 65.16%, and includes rejections, withdrawals and abandonments also. Pre grant opposition has also helped in increasing the vigilante of Patent office since in 9 cases even when the grounds of opposition were rejected the patents were rejected by the examiner.
These possitive signs could not release the tension of the situation as the panel as well as the audience were involved in the serious situations which the TRIPS have put India into and concluded that India’s service as world’s pharmacy would not last longer.
Access to Medicines in Middle-Income Countries: The Case of Hepatitis
Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV).There is global epidemic of hepatitis C, with approximately 150 million people (WHO) and 350,000 – 500,000 deaths estimated annually. Over 80% of those affected by the disease live in middle –income countries, especially in central, north and West Africa. Several middle –income countries such as Egypt, Nigeria, and Pakistan have a high burden of hepatitis C. Approximately 80% of newly-infected people are asymptotic, which makes it difficult to diagnose and treat those who go to develop chronic infection.
HCV is prevalent in middle – income countries. Middle –income countries, though home to most of the world’s poor, have growing middle classes representing economic opportunities for pharmaceutical companies. As a result, companies have an incentive to maintain exclusivity and charge higher prices in these markets. This may discourage donor, insurer and government investment in new expensive new treatments, potentially slowing the adoption of new medicines.
It is clear that treatment of hepatitis C is undergoing a revolution. All actors in the global health community need to ensure that these new products are available, accessible and affordable for all in need. Pharmaceutical companies have central roles to play, particularly with regard to ensuring affordability and voluntary licensing.
How to build a popular campaign for R&D reform:
This interactive session ‘How to build a popular campaign for R&D reform: establishing the key components’ was chaired by D. McDonald. Initially, there were some discussions concerning the problems associated with campaign building such as lack of public understanding and effectiveness of these efforts which can be solved by connecting with people through simplifying the agenda. Zakir Thomas raised the issues in Indian context where the public opinion is very hazy which requires alternative solutions. Further, the session was divided into the three groups: communication and narration, Movement challenges and strategic movements. James Love and Zakir Thomas were in strategic movements group where they emphasized the need of national movement in India to promote biomedical research and healthcare delivery as it has become crucial after recent World Health Assembly (WHA). An important point which came from this discussion was to open up the process among government negotiators, civil society and WHO representatives in first quarter of 2016. Moreover, intergovernmental pressure can also be harnessed to make a campaign successful as people or negotiators changes due to some political reasons.
This interesting session was really fruitful from Indian perspective as Zakir showed his commitment to make collaborative changes in a timely manner before the coming WHA. James also shared his opinion to promote health insurance in India, which should be taken seriously.