Remembering Seamus Heaney

FROM THE REPUBLIC OF CONSCIENCE

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This poem was written by Seamus in 1985 at the request of Mary Lawlor of Amnesty International Ireland to mark International Human Rights Day. It has since inspired a generation of human rights activists. Amnesty International’s highest award – the Ambassador of Conscience – is inspired by this work.

 

 

 

I

When I landed in the republic of conscience

it was so noiseless when the engines stopped

I could hear a curlew high above the runway.

 

At immigration, the clerk was an old man

who produced a wallet from his homespun coat

and showed me a photograph of my grandfather.

 

The woman in customs asked me to declare

the words of our traditional cures and charms

to heal dumbness and avert the evil eye.

 

No porters. No interpreter. No taxi.

You carried your own burden and very soon

your symptoms of creeping privilege disappeared.

 

II

Fog is a dreaded omen there but lightning

spells universal good and parents hangs

waddled infants in trees during thunderstorms.

 

Salt is their precious mineral. And seashells

are held to the ear during births and funerals.

The base of all inks and pigments is seawater.

 

Their sacred symbol is a stylized boat.

The sail is an ear, the mast a sloping pen,

the hull a mouth-shape, the keel an open eye.

 

At their inauguration, public leaders

must swear to uphold unwritten law and weep

to atone for their presumption to hold office –

 

and to affirm their faith that all life sprang

from salt in tears which the sky-god wept

after he dreamt his solitude was endless.

 

III

I came back from that frugal republic

with my two arms the one length, the customs woman

having insisted my allowance was myself.

 

The old man rose and gazed into my face

and said that was official recognition

that I was now a dual citizen.

 

He therefore desired me when I got home

to consider myself a representative

and to speak on their behalf in my own tongue.

 

Their embassies, he said, were everywhere

but operated independently

and no ambassador would ever be relieved.

 

“From the Republic of Conscience,” from Opened Ground: Selected Poems 1966-1996 by Seamus Heaney. Copyright © 1998 by Seamus Heaney.

 

Emmanuel Oke: On the Novartis case, the Indian Supreme Court and the Right to Health

We are delighted to welcome this blog post from Emmanuel Oke, PhD candidate here at the Centre for Criminal Justice and Human Rights, UCC.

THE INDIAN NOVARTIS CASE: FINDING THE RIGHT BALANCE BETWEEN ACCESS AND INNOVATION

Emmanuel OkeEmmanuel Oke*

Earlier this year, in April, 2013, the Indian Supreme Court delivered the much awaited judgment in the appeal filed by Novartis against the refusal of the Indian patent office to grant a patent on its cancer drug, Glivec. The patent office and the Indian Intellectual Property Appellate Board had both decided that Novartis’ patent application failed to meet the requirements of section 3(d) of the Indian Patents Act. Section 3(d) prohibits the grant of patents on new forms of known drugs unless the patent applicant can demonstrate that the new form has ‘enhanced therapeutic efficacy’ over the previously known drug. In its decision, the Indian Supreme Court equally held that Novartis had failed to meet the requirements of section 3(d).

The active ingredient in Glivec is a derivative of a drug compound called ‘imatinib’. Novartis had improved upon ‘imatinib’ by converting it into a salt form called ‘imatinib mesylate’ and it was from ‘imatinib mesylate’ that Novartis derived the most stable version of the drug compound, a particular polymorphic form called the ‘beta crystalline form of imatinib mesylate’. This beta crystalline form is the active ingredient in Glivec. The argument of Novartis was that Glivec could not be denied a patent based on section 3(d) because the active ingredient in Glivec was more effective than ‘imatinib’ as it was absorbed easily in the bloodstream and there was a 30% increase in bioavailability (bioavailability is the degree and rate at which a drug is absorbed into a living system or is made available at the site of physiological activity). The Indian Supreme Court however held that Novartis failed to provide evidence to establish that the increase in bioavailability results in ‘enhanced therapeutic efficacy’ (para. 189). But what exactly is ‘enhanced therapeutic efficacy’? How can a patent applicant establish ‘enhanced therapeutic efficacy’? These questions will be addressed later on in this post.

It is important to note that section 3(d) was introduced into the Indian Patents Act in 2005 when India had to amend its patent law to provide patent protection for pharmaceutical products as required by the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). Prior to 2005, India had previously amended its patent law in 1970 to exclude pharmaceutical products from patent protection. This exclusion of patent protection for pharmaceutical products enabled the local pharmaceutical companies in India to develop the capability to produce cheaper generic versions of drugs that were patented in other countries. The production of cheaper generic drugs within the country thus ensured that drugs were not prohibitively priced beyond the reach of poor patients. Besides, Indian drug companies have become major suppliers of generic drugs to several developing countries, hence the description of India as the ‘pharmacy of the developing world’. The objective behind the introduction of section 3(d) was to ensure that only ‘genuine’ pharmaceutical innovations were granted patent protection in India. Section 3(d) was essentially designed to prohibit what is known as ‘ever-greening’ where a drug company obtains several layers of patents on different forms of the same drug. Section 3(d) therefore raised the bar for drug patent applicants and this was designed to ensure that local drug companies in India could still continue to produce generic versions of drugs that failed to meet the requirements of the patent law.

To be sure, there is a huge problem of lack of access to essential medicines in India. In actual fact, it has once been reported that India has the largest number of citizens with no access to essential medicines. Also, as noted above, several developing countries are dependent on supplies of cheaper generic drugs (including anti-retroviral drugs) from Indian drug companies. This therefore explains why Indian lawmakers introduced several provisions (including section 3(d)) into the Indian patent law in 2005. The lawmakers wanted to ensure that compliance with the requirements of the TRIPS Agreement would not have a negative impact on access to medicines and the right to health of Indians and other poor patients in other developing countries. It should be quickly added that the TRIPS Agreement permits countries, when formulating or amending their laws, to adopt measures necessary to protect public health (Article 8(1) TRIPS). This was subsequently reaffirmed in the Doha Declaration on the TRIPS Agreement and Public Health of 2001. Therefore, India has not breached its international obligations by introducing section 3(d) into its patent law.

There is no doubt that the decision of the Indian Supreme Court in the Novartis case is a triumph for the right to health, particularly the right to have access to affordable medicines. It is however crucial to also consider whether a provision like section 3(d) can potentially have a negative impact on access to essential medicines in the long term. While section 3(d) serves as a prohibition against ‘ever-greening’, there is a significant risk that certain useful incremental pharmaceutical innovations (i.e. useful improvements of known drugs) may also fail to meet the requirements of this provision. It should be noted that most domestic drug companies in India do not currently possess the capability to produce highly innovative drugs and they can only engage in incremental pharmaceutical innovation. It is therefore essential to encourage these domestic drug companies to engage in incremental pharmaceutical innovation as this will consequently lead to the development of the capability to produce highly innovative drugs and it can also encourage these domestic companies to invest in the development of drugs for treating diseases that primarily affect patients in India.

This brings us back to the earlier questions regarding what constitutes ‘enhanced therapeutic efficacy’. Unfortunately, the Indian Supreme Court failed to define or describe the scope of what constitutes ‘enhanced therapeutic efficacy’. The court was content to hold that it was unnecessary to decide this crucial issue because on the facts before it, Novartis had failed to provide evidence to demonstrate ‘enhanced therapeutic efficacy’. The implication of this is that, right now, no one actually knows the exact requirements that one has to fulfill before the demands of section 3(d) can be satisfied. Though the court was of the view that its decision was not a bar against incremental pharmaceutical innovations (para.191), by failing to specify what constitutes ‘enhanced therapeutic efficacy’, there is a risk that potentially useful incremental pharmaceutical innovations may not meet the requirements of section 3(d). It should always be remembered that fostering pharmaceutical innovation and facilitating access to medicines are both crucial to securing the right to health.

*PhD Candidate, Faculty of Law, University College Cork.

http://research.ucc.ie/profiles/B012/111220443

http://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=1681210

Authors meet Readers series: Dr Olufemi Amao on Corporate Social Responsibility

‘Authors meet Readers’ series: celebrating the work of UCC PhD Law graduates  

I am delighted to introduce Dr Olufemi Amao as part of our ongoing ‘Authors meet Readers’ online series, celebrating the distinguished research and publishing of our PhD graduates. Dr Amao completed his PhD  at UCC in 2008, and also lectured at UCC in the areas of Business Law. He was an active contributor to our PhD graduate training programme and to the activities of the Centre for Criminal Justice and Human Rights. Femi copyOne of my favourite photographs from the launch of the CCJHR is Olufemi with a graduate of the LLM (Research) programme, Nikolaos D. Stamatakis.

 Olufemi’s blog post reflects on the themes addressed in his PhD, and recently published in his monograph, as part of the Routledge Research in Corporate Law series. Olufemi has also published in several leading international journals, and continues to make a significant contribution to the emerging body of law on Corporate Social Responsibility and International Human Rights Law. Full details of his many publications are available at: http://www.brunel.ac.uk/law/people/academic/olufemi-amao

 Femi

Delighted to welcome, Dr Olufemi Amao:

Reflections on my book: Corporate Social Responsibility, Human Rights and the Law: Multinational Corporations in Developing Countries

My book Corporate Social Responsibility, Human Rights and the Law: Multinational Corporations in Developing Countries was published in 2011 as part of the Routledge Research in Corporate Law series. Based on my doctoral research which I completed at UCC in 2008/2009, the book addresses the confluence between the concept of Corporate Social Responsibility (CSR) and the law against the backdrop of the control of Multinational Corporations (MNCs).

Femi bookMNCS have significant economic and social impact in their global operations which are not always beneficial. Available evidence shows that such negative impact is pronounced in the area of human rights.  The control of MNCs continues to be a challenge to law making institutions both at domestic and international level. The response of MNCs themselves to this challenge is to adopt voluntary CSR strategies in the hope that this will discourage law makers from imposing statutory standards of CSR.

The United Nations continue to explore options of establishing international CSR standards, and international organisations such as the Organisation for Economic Co-operation and Development (OECD) are actively contributing to this effort. My book contributed to the discourse especially from the perspective of developing countries. A key argument that I made is that for the concept of CSR to be relevant and effective, there needs to be a balanced interaction between the concept and the law. The law at domestic and international level can be employed in creative ways to enhance the concept of CSR.  In the book I made various suggestions on how this can be achieved.

The importance of this book is underscored by recent developments both at the domestic level and at the international level. The United Nations recently introduced the Framework for Business and Human Rights and the Guiding Principles on Business and Human Rights developed by the former UN Special Representative for Human Rights and Business, Professor John Ruggie .[1] This was the latest attempt by the UN to create an international standard for CSR, a theme that was extensively covered in my book.

 One of the chapters in the book discusses the potential of the judicial application of the Alien Tort Claims Act in the United States, and how this may impact on international standards for MNCs.  The statute conferred jurisdiction on the US federal district court to adjudicate on cases brought by foreigners against entities including MNCs. Legal experts and major international organisations saw the ATCA process as the most effective way for enforcing international standards against MNCs. However there has been a setback to this idea. In a recent decision in Kiobel v Shell[2] on April 17, 2013 the Supreme Court of the United States effectively closed this avenue. The court in that case severely limited the ability of foreign litigants to enforce international human rights standards against MNCs in US courts.

A few words on me and my career so far. I am currently a Lecturer at Brunel Law School, Brunel University, London. I teach a number of subjects including Company Law, Banking Law and International Finance Law. My research area is wide ranging and includes: Company Law, Corporate Law Theory, Corporate Governance, Corporate Social Responsibility, Multinational Corporations, Human Rights and International Law. I am currently working on a book on ‘African Union Law’.  I completed my PhD studies (under the supervision of Professor Irene Lynch Fannon and Professor Ursula Kilkelly) supported by the President’s PhD scholarship and the Department of Law Postgraduate Research scholarship. Further information can be found here: http://www.brunel.ac.uk/law/people/academic/olufemi-amao


[1] ‘Protect, Respect and Remedy: A Framework for Business and Human Rights’, Report of the Special Representative of the Secretary General on the issue of Human Rights and Transnational Corporations and other Business Enterprises, A/HRC/8/5 (7 April 2008); Human Rights Council,  ‘ Guiding  Principles  on Business and Human Rights: Implimenting the United Nations “Protect, Respect and Remedy” Framework’, A/HRC/17/31 (21 March, 2011).

[2] Esther Kiobel et al. v. Royal Dutch Petroleum Co., et al. No. 10-1491