Thoughts in Colours

Training for Research on Development - IDRC Internship Awards for 2011

2010-08-20T17:01:00.000+02:00

Read my blog on this on the Ideas in Development Blog at http://www.iqsensato.org/blog/2010/06/24/internships/.

Kenya: Our Possible Futures; Our Choices

2009-07-20T07:47:00.001+02:00

My piece with this title has been published on "African Arguments" as part of the online debate on violence and accountability in Kenya. It is available at http://africanarguments.org/author/sisule-musungu/

Obama's Africa Policy

2009-07-16T15:44:00.001+02:00

My response to Obama's Ghana Speech. Available on Ideas in Development Blog at http://www.iqsensato.org/blog/2009/07/11/obamas-africa-policy-a-response-to-the-ghana-speech/

International Opportunities for the Obama Administration and the EU “to do Good” on Patent and Copyright Policy in the Next Four Years

2009-01-13T19:10:00.011+01:00

1. Introduction
The need for intellectual property (IP) policy and rules to adequately respond to socio-economic and technological transformations of recent decades and to development imperatives has been recognised internationally for some time now.

The adequate response should entail:
-Rebalancing patent and copyright rules and policy to better reflect the public interest;
-Evolving international standards on patents and copyrights based on better socio-economic evidence and impact assessment;
-Taking better account of the different levels of development of different countries that make up the community of nations; and
-More openness to new business models which may not necessarily require exclusive rights as incentives.

Efforts to address these needs by different stakeholders, most notably, civil society organisations, developing countries and academics and researchers as well as enlightened funding and development agencies have so far yielded important positive results. Some of the milestones include: the adoption of the Doha Declaration on the TRIPS Agreement and Public Health in 2001; the report of the World Health Organization (WHO) Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) in 2006; the adoption of a development agenda for World Intellectual Property Organization (WIPO) in 2007; the adoption of the WHO Global Strategy and Plan of Action on Public Health, Innovation and IP in 2008 as well as a new work programmes for the WIPO Standing Committee on Patents (SCP).

At the same time, however, other stakeholders, most notably, industry groups and lobbyists in the pharmaceuticals, software, film and music industries and the US and EU governments together with their Organization Economic Cooperation and Development (OECD) partners have embarked on various initiatives to ratchet-up or create new standards and rules on patents and copyrights especially in the area of enforcement. While some of the concerns raised by these groups and governments are legitimate, they efforts have largely been based on inflated figures of business losses from IP infringement, fear mongering and threats, forum shopping and lately, in the context of the negotiations on the proposed Anti-Counterfeiting Trade Agreement (ACTA), dubious treaty-making or what I call “counterfeit policy-making”.

Overall, however, in the next four years, the Obama administration and the EU, have a number of opportunities to do good, meaning that they can meaningfully contribute to promoting balanced and opportunity enhancing international patent, copyright and access to knowledge policies. Below, I outline what are the main opportunities that the Obama administration and the EU can seize to do good in the next four years. But first a few words on the role of leadership in doing good.

2. Doing Good: The Role of Leadership
“Change has come to America” Obama declared during his victory speech on 4th November 2008. In simple terms, when Obama talks about change coming to America, I assume that he means that by virtue of the change in leadership there will be changes in the political and socio-economic operations in the country and beyond. For a person who works on international patent and copyright policy as well as innovation for development, the question I ask myself is: What change has come, or is coming, with respect to the approach of America to global knowledge governance and on patents and copyright policy?

The ability of the Obama administration and EU institutions to do good on patent and copyright policy will depend on leadership both at the top and within the ranks. In the current global circumstances, US leadership will probably matter the most. For the US to do good on the international stage will require engagement and real leadership from Obama himself as well as at four other levels, at least. Leadership will be required of whoever occupies the position of: ‘IP Czar’, as the new White House position on IP enforcement has come to be popularly known; the United States Trade Representative (USTR); head of the United States Patent and Trademark Office (USPTO); and head of the United States Copyright Office. Leadership at these four levels will mean, at least, that when these people take the plane or send representatives to Geneva or to Latin American, Asian or African capitals for negotiation or discussions on IP they will be thinking of engaging partners, negotiating for legitimate interests based on evidence and facts as opposed to the attitude that they are going to meet ‘IP thieves and pirates’, ‘counterfeiters’, ‘communists’ etc.

Of course, for leadership on the Obama administration side and in the EU to lead to anything there has to be similarly enlightened leadership of countries like Brazil, India and African countries such as South Africa, Egypt, Kenya and Nigeria. The ability of these countries to be real partners and to defend and promote their initiatives also based on evidence and facts and to follow through key agendas will be critical to avoid a situation where the agendas of international organisations are filled up with only on hot air. Equally important will be the leadership and sensitivity in key international organisations such as WIPO, WTO, WHO, the World Customs Organization (WCO), among others. Finally, an understanding of the importance of good global policy on knowledge governance and, by extension patent and copyright policy will be required of the leaders of major funding and development agencies. Foundations and development agencies which claim to be interested in innovation for development and in the public interest in the knowledge society but fail to support the evolution of balanced and opportunity enhancing patent and copyright policies are clearly not good partners in any effort by the Obama administration or EU institutions to do good on global knowledge governance.
3. Opportunities to do Good on Global Patent and Copyright Policies
Without re-inventing the wheel, and without any many major policy reversals, the incoming US administration and the EU institutions have a range of opportunities to do good in international patent and copyright arenas. In particular, there are opportunities to significantly contribute to meaningfully addressing the challenges we face in the areas of: innovation and access to medicines; patent standards including questions around mechanisms to support collaborative and other business models; copyright in the digital age; and IP enforcement. There is also a basis to do good in other areas and forums.

3.1 Doing good on innovation, health research and access to medicines

The relationship between patents and access to essential medicines especially in developing countries has been a point of major controversy in international IP policy-making. On the one hand, developing countries and health groups have argued against current approaches to patent rights in the pharmaceutical sector on the basis that the monopoly-based approach relies on high medicines prices which puts these essentials out of the reach of those who need them most. On the other hand, developed countries, such as the US, have argued for stringent minimum rules on the basis that such protection was essential for innovation. Without resorting to the name calling, intimidation or insults, in the way that certain industry lobbyists have done, a small but dedicated group of civil society organisations, academics and researchers decided to find a way in which the legitimate concerns of industry and innovative businesses regarding incentives and funding could be addressed while assuring access to essential medicines for all. It is through these efforts that we now have A Global Strategy and Plan of Action on Public Health, Innovation and IP, which was adopted by the World Health Assembly in May 2008. We now face the challenge of implementation and monitoring.

The Global Strategy “aims to promote new thinking on innovation and access to medicines as well as ... provide a medium-term framework for securing an enhanced and sustainable basis for needs driven essential health research and development relevant to diseases which disproportionately affect developing countries...” To do good, the Obama administration and the EU have to politically and financially support the implementation of the Strategy including insisting that the expert group on financing comes up with workable solutions and not shortcuts. There is also a need to avoid a multiplicity of half-baked new initiatives and to promote transparency at the WHO. If WHO succeeds in missing this opportunity to address the 10/90 gap now the issues will come back again to occupy the international policy space that could be utilised to address other issues. It must be remembered that while we have known of the 10/90 gap for a long time the initiative to look for innovative solutions did not come from within the WHO Secretariat but rather through the efforts civil society and NGOs, countries such as Kenya and Brazil, academics and researchers and a few funding agencies.
3.2 Doing good on patent policy
The geo-economic transformations that we are witnessing today coupled with the current financial crisis and the attendant employment and competiveness worries means that we are likely to see increased pressure on the patent system and patent policy. There are clearly many opportunities for the Obama administration to do good on US patent reform with spill over effects internationally. But there are even greater opportunities to do good at the international level.

We would remember that between 2002 and 2007 the US, the EU and Japan tried, unsuccessfully, to ram down the ‘throats’ of other nations an international patent reform package in the name of the draft Substantive Patent Law Treaty (SPLT) at WIPO. That effort failed because instead of seeking to convince other countries, the US and the EU decided to use intimidation, threats “to leave WIPO” and, with the connivance of the ex-Director-General of WIPO, secret conclaves that sought to by-pass proper governmental machinery in countries like India. In the end, sanity has prevailed and now WIPO has the most forward looking agenda on patents in its history.

The agenda seeks to address a range of important issues of interest to all Members states and, most importantly, to many stakeholders who, hitherto, were not considered stakeholders in the patent system. In particular, the current work programme of the SCP includes work on: economic impact of the patent system; transfer of technology; competition policy and anti-competitive practices; dissemination of patent information; standards and patents; alternative models for innovation; harmonization of basic notions of substantive patentability requirements; disclosure of inventions; database on search and examination reports; opposition system; exceptions from patentable subject matter; limitations to the rights; research exemption; compulsory licenses; client-attorney privilege; patents and health; the relationship between the patent system and the CBD; and relation of patents with other public policy issues.

To do good on patent policy internationally the Obama administration and the EU can do no better than to support balanced and results-oriented execution of the new WIPO programme.

3.3 Doing good on copyright policy

The internet and other advances in communications technologies have unleashed many opportunities for innovation, entrepreneurship, social interactions and political participation. Instead of these transformations ushering in an era for rethinking copyright policy to enable both consumers and creative communities to benefit, however, we have seen an explosion of demands for new copyright and other related rights. Following the conclusion of the WIPO Internet treaties in 1996, the international community has mainly dedicated its energy on a rather dubious attempt to introduce new exclusive rights for broadcasting organisation in the name of preventing ‘broadcast signal piracy’. This was a brainchild of the Europeans with the support of the US. This effort faltered because when the proponents were confronted with basic questions about justification, evidence and proportionality they had no convincing response.

In the last few years, with the leadership of Chile, the question of limitations and exceptions has been given some space on the agenda of the WIPO Standing Committee on Copyright and Related Rights (SCCR). In the latest session, a concrete proposal was presented on exceptions for the visually impaired. The case to move on this proposal is not only backed by good evidence but is compelling. The studies done or commissioned by the WIPO Secretariat as well as information meetings they have organised on exceptions have also shown the importance of the issues not only on the question of exceptions for the special needs but more generally.

To do good on copyright the Obama administration and the EU could do alot of service to the world by dropping any demand for further negotiations on broadcasting organisation, until there is better evidence and instead support the agenda on limitation and exceptions. The result of such a process would benefit not only people in developing countries but in the US and in many European countries as well. Of course, other issues that are shown to merit attention should also be addressed by the SCCR in the next four years.

3.4 Doing good on IP enforcement

Current US and EU initiatives on enforcement such as ACTA and work at WCO threaten to do alot harm, especially in developing countries. ACTA is a particularly worrisome development. The stated goal of ACTA is to establish ‘a common standard of IP enforcement to combat global infringement of IP’. It is clear from the stated goal of the effort that the standards sought to be developed will not only apply in the participating countries but to other countries including being a basis for processes such as the Special 301 Reports or technical assistance programmes for developing countries.

There is no denying that any group of countries have the sovereign right to negotiate trade or other agreements to address shared concerns within their territories. So why is ACTA a problem? The problem with ACTA, simply stated, is that a small number of countries, driven by a narrow set of industrial interests, are proposing to tackle what they call ‘a global problem’ by developing a tool with ‘global reach’ while excluding the majority of the world population from the standard-setting process.

To do good on IP enforcement the Obama administration can start by reversing the Bush administration’s policy of secret negotiations which lack democratic credentials not only internationally but in the US itself. The new Commission in Europe at the end of the year should follow suit. If the US and EU cannot provide convincing evidence and argumentation why international institutions such as WTO and WIPO should address new enforcement standards then something is quite wrong with the evidence-base.

3.5 Doing good in other forums and processes

There is no doubt that IP policy issues and demands for new rules or regulations will crop up in various other arenas. The UN Climate change negotiations are one good example where patent and technology transfer issues have become prominent. There is a broader opportunity for the Obama administration and the EU to always do good whenever IP issues come up in negotiations. This could be done by applying the principles on norm-setting agreed under the WIPO Development agenda in 2007. While these principles were agreed in WIPO they are applicable to any other international IP norm-setting activities.

In this regard, the Obama administration and the EU can do good on patent and copyright policy at all times by supporting the application of these principles more widely. The said principles include that norm-setting processes on IP should:
-Be inclusive and participatory taking into consideration the interests and priorities of all stakeholders;
-Take into account different levels of development in different countries;
-Take into consideration a balance between costs and benefits of new norms or rules;
-Be supportive of the development goals agreed within the United Nations system, including those contained in the Millennium Declaration; and
-Should address, as appropriate, issues such as flexibilities, exceptions and limitations for Member States and special provisions for developing countries and least-developed countries (LDCs).

While these are basic principles of good governance, they are often forgotten in the IP policy-making processes.
4. Conclusion
The Obama administration and the expected new European Commission towards the end of the year have a range of opportunities to do good on patent and copyright policy. To succeed in doing good will require credible leadership not only at the top but within the ranks including at places such as the USTR and USPTO. Success will also, however, depend on leadership from developing countries and by the Director-Generals of international institutions such as WIPO, WTO and WHO.

What should be done with Mugabe?

2008-12-08T15:33:00.002+01:00

What should be done with Mugabe?

What should be done with Mugabe?

What should be done with Mugabe?

Obama's Triumph: Lessons for Africa and Beyond

2008-11-05T15:37:00.010+01:00

Barack Obama's election as the next president of the United States of America is historic in many ways and for many reasons. The celebrations that erupted across America and across the world tell a story of a lifetime. I have been blessed in my lifetime to have seen one other moment like this. Another momentous occassion marked by an equally elegant and inspiring speech. This was on the 10th of May 1994 when Nelson Mandela was inaugrated as the first black president of South Africa. Then, as today, there were global celebrations; the world was filled with hope and the human spirit had triumped again. On that historic day, Mandela uttered many immortal words but one of the most powerful statements for me was the following: "Never, never again will this beautiful land experience the oppression of one by another." While Mandela did, and continues to do what he can to make that statement come true, South Africa still faces many challenges. What is the relevance of this to Obama's election, one might ask? The relevance is that as we celebrate another first for African, it must not be lost to us that a historic moment is a moment for education and reeducation. There are many critical lessons from Obama's life history and his electoral triumph. Some refelections on lessons for me for Africa and beyond.

Warped priorities

Africans, whatever their origin, should be proud and should celebrate this moment in history. Many continue to endure racial hatred not just in the US but in Europe, in Asia and elsewhere. Many remain scarred by the legacy of colonialism, slavery and apartheid. But in celebrating, we should not miss an important lesson from Obama's journey. Obama is gifted in many ways. His intellect, calmness, oratorical skills and other gifts have been well analysed in the last two years . But even for someone so gifted, he had to work so hard to achieve what he achieved. And even after this momentous victory, tomorrow morning he will be taking his children to school and starting work straightaway. He did not declare a holiday for himself or his family. He knows that there is alot of work ahead and celebration should not make him lose sight of this. Compare that to the reaction in Kenya. President Kibaki, on the utterly flimsy grounds, declared a national holiday. In a country which had two public holidays in October (Moi and Kenyatta days) and a litany of other holidays in the year; for a country which lost the first quarter of the year in bloodshed and economic suffering; for a country that has 42 ministers to pay how on earth do you celebrate the life of Obama by going on holiday?. The lesson for Kibaki should have been why hard work is important why Kenyans should have gone to work and rededicated themselves to nation building. There is nothing that demonstrates better why African countries like Kenya might have difficulties uplifting their people! Priorities can not be so warped.

Shaking off the shackles of history through self-belief

There are some who says Obama's ancestors were not slaves so he is not truly African American. To that I say complete nonsense. Obama's ancestors were colonised, an equally brutal form of oppression. What is most important, however, is what we can learn from Obama's attitude towards history. While he has no illusions about racism and the scars of slavery, he believed in himself, celebrated the opportunities he was afforded and took charge of his destiny. For Africa, especially African leaders, it is time to change their attitude towards the colonial history. Always focusing on colonial masters et al obscures the opportunities we have and the differnce we can make.

Trumpeting "Experience" to cover up for quackery

The McCain campaign, and before that Hillary Clinton's campaign, tried and failed to bring down Obama by claiming he had no experience. Even Sarah Pallin dared claim she would lead better. Obama triumphed because he was willing to learn, he chose his staff from the young and the old, based on their knowledge and expertise, to be in his team. What we can learn from Obama is that honest experience is an asset but age alone does not bestow wisdom or indeed useful experience. McCain in his concession speech admitted as much. Africa's leadership in government and beyond continues to be peopled by individuals who use age as equal to experience. This denies many millions the oportunity to make a difference in government, business and elsewhere. But the phenonmenon is more widespread. Developing country organisations such as South Centre have been turned into retirement homes. Experience is trumpeted to cover up for quackery.

As Obama said in his acceptance speech there is new energy to harness. It is in the young and dynamic. Countries such as Rwanda which have understood this are starting to reap handomely.

In praise of women

There were many people in Barack Obama's life that supported him and inspired him. But five women seem to stand tall among them. These are his mother and his grandmother (may God bless their souls), Michelle Obama and his two daughters. You cant help but see in this victory women allover.....The great thing about Obama is he never forgot this. For Africa and many other places in the world the lesson is to cherish and celebrate women in our communities. The story of Hadijatou (http://www.interights.org/niger-slavery/index.htm) which has been in the new recently reminds us that there are far too many women still suffering through the lack of opportunity, oppression and discrimination.

When you dare to hope you must be prepared to act

Obama dared to hope and deliberately acted on his hopes. It is this that has made a difference. This teaches us that hope alone will not change our fortunes. While it is true that Obama has inspired hope for millions, if not billions, the lesson we should learn from his story is that he hoped and acted. The problem for Africa and many others might be that we just to hope for a better world without acting to create a better world.

With Respect to McCain

2008-11-05T15:26:00.005+01:00

Today, was Obama's day! He won a landslide victory in a hard fought race, and he gave an elegant and inspiring victory speech. I expected nothing less.

But in defeat, John McCain earned back my respect; respect he had lost by the pettiness of his campaign, the fear mongering and the name calling in the last days of the race. His grace in deafeat was equally inspiring for me. In particular, the following words, among others inspired me:

"I won't spend a moment of history regretting what might have been."

Hats off to the comeback kid... At least he came back to respectability!

My Best US Election Quote

2008-11-04T08:49:00.004+01:00

The 2008 US Presidential Campaign has finally come to an end, and today, it is decision day for Americans. For over two years, we have been entertained, educated and, at times, terrified. Out of all the billions of words spoken and thousands of speeches made I have one short quote that for remains the best. It is the following:

"[I]t's is not the magnititude of our problems that concerns me most. It's is the smallness of our politics." Barack Obama.

It is a phrase Obama has used many times but it remains so powerful.

Ndesanjo Macha Wakes me Up from my Blog Slumber

2008-10-07T15:53:00.003+02:00

The last tme I blogged was over a year ago. I still write, think and talk but not on the blog. Somehow it slipped.

But today, 7th October 2008 in Nairobi at the HAI Africa/SATAMO/OSI seminar on access to essential medicines, Ndesanjo Macha (see http://globalvoicesonline.org/author/ndesanjo-macha/%20or%20) of global voices woke me up from the long slumber. He did this by giving the most compelling reasons for using a blog I have ever heard. He was talking to generally small civil society organisations from a dozen or so countries in Africa. This group of campaigners and activists were thinking about how to use new media to reach their goal of access to essential medicines for all by "knocking out stockouts" of medicine in health facilities in Africa. With small resources, limited human resources, technological limitations etc. at the end of it all these folks moved beyond the age old idea that "not everyone has access to a computer or internet".

But his talk also brought home to me the message of the failure of many seeking to change the world (say to bring essetial medicines to all, water all etc.) to adapt to how the world is changing. The failure to take the opportunities of today (cellphones, blogs etc.) to change the world. If you want to change the world you have to join the revolution was another thought at the end of it all.

To him I say, Nashukuru sana na ahsante!

The WIPO Development Agenda: Why WIPO leadership matters in Implementation

2007-09-30T18:50:00.000+02:00

On Friday, 28th September 2007 the World Intellectual Property Organization (WIPO) General Assembly finally adopted a development agenda for WIPO. The Assembly adopted a set of 45 proposals under six clusters, namely: technical assistance and capacity building; norm-setting, flexibilities and public domain; technology transfer, ICTs and access to knowledge; assessment, evaluation and impact studies; institutional matters including mandate and governance; and other issues such as a development approach to enforcement of intellectual property (IP). A committee on Development and Intellectual Property (CDIP) will be responsible for developing a work programme for implementation of these recommendations and for monitoring, assessing and reporting on implementation as well as coordinating with relevant WIPO Committees for these purposes.

There is no doubt that the adoption of the development agenda was one of the most important issues on the agenda of the 2007 WIPO General Assembly and the Members of the Group of Friends of Development rightly pointed this out (See, for example, the IP-Watch story by William New at http://www.ip-watch.org/weblog/index.php?p=762&res=1280). But there is also no denying that the development agenda and all other issues on the agenda of the General Assembly and other Assemblies of WIPO were overshadowed by the wrangles regarding whether the Director General of WIPO, Kamil Idris should step down for falsification of his age on various official documents including on visa applications (the latter being a criminal offense in many countries and a reason to be permanently barred from entering a country).

The two camps

While there are many interests and shades of opinion, this wrangle has been portrayed as pitting two sets of members states. The African Group, with the implicit or explicit support of many other developing countries (Mr. Idris’ “brothers”) and the United States and the European Communities (EC) with the support of the Swiss, Japan and many other developed countries (whom Dr. Idris has variously called racists or people with an agenda against the organization and his person). Dr. Idris is a cornered man. The rather vitriolic note issued in the name of the WIPO Secretariat at the start of the General Assembly on Monday, 24th September and the rejoinder by the President of the UN Joint Inspection Unit (JIU) on 25th September as well as the e-mail from the internal auditor who unearthed the age scandal speak volumes.

Apart from Member States, the debate has also obviously divided the WIPO Secretariat especially at senior management levels with those seen to be in Idris’ camp and those seen as supporting the United States and its friends or sitting on the fence.

Leadership and the Implementation of the Development Agenda: The connection

The position of Idris remains uncertain. But whether he steps down or not, the chasms that have been opened by this debacle are likely to haunt WIPO for some time to come. This is where the connection to the Development Agenda implementation comes in.

The full implementation of the Development Agenda will mean significant reform in WIPO. Coupled with the implementation of the results of the Desk-to-Desk review and the new budgeting and audit structure it means that WIPO is in the midst of its biggest reform since its founding some 37 years ago. It does no need a management expert to tell us that for an organization to navigate such major reform requires leadership from the top. Such reform cannot happen with an embattled Director General and a divided Secretariat and it cannot happen with a sharply polarized membership. Luckily, the Development Agenda had moved from a polarising issue among the membership to a shared reform platform . If the leadership question is not handled properly, it risks derailing the development agenda and returning us to 2004. For this reason, the Group of Friends of Development and other developing country as well as the development-friendly civil society groups and NGOs have the highest stake in ensuring the proper and speedy conclusion to the leadership question at WIPO.

The Silence Option

The supporters of the Development Agenda have three options on how to engage on the question of the position of Idris. One option is to take the attitude that this is not our problem; our agenda has been approved so we keep quiet on that question. The silence among civil society groups, in particular, suggest that most have taken this position. However, as I have already pointed out, WIPO leadership has everything to do with the Development Agenda. The Agenda was partly aimed at checking bad leadership at the organisation and its implementation requires prudent, corruption-free leadership at WIPO. Those who genuinely believe in the reform of WIPO based on the Development Agenda cannot therefore choose the silence option. Imagine the hue and cry that would have come from governance focused civil society and others if this debacle had related to Pascal Lamy of WTO, for example. Or think back to the Wolfowitz saga at the World Bank.

The silence approach harms rather than promotes opportunities and respect for developing countries in international organisations.

The “Brother” Option

Does the United States, the EC and others who are asking Idris to honorably step down have an agenda? You bet they do. They have made that very clear, anyway. Is that wrong? If you do not like their agenda one of your best defenses is never ever give them a reason or excuse to come after you. Kamil Idris gave them a reason and in light of that their motivations cease to be the primary issue. It is whether illegal and/or unethical behavior took place or not. Wolfowitz also claimed that there were people out to finish him for ulterior motives. I come from a country which in the last two decades has invariably been ranked as highly corrupt. For this reason, I know that every corrupt person uses the same excuse when they are caught.

In this context, the second option the pro-development groups have is to defend Idris directly or indirectly based on the argument that this issue has been brought up to divert attention from important issues such as the Development Agenda. This is also not a prudent option. One cannot put beyond some in the WIPO Secretariat to seize on the Development Agenda as a shield for Idris by arguing that this issue is diverting attention from the Agenda or that it is only him who can implement the Development Agenda. It should not be lost on the advocates of the Development Agenda that in the early days of the development agenda, when Idris and a number of senior WIPO officials were openly hostile to the proposal; a time when calls were made to Ambassadors and developing country capitals to reign in some delegates who were “pursuing their own agenda”, arguments were made to suggest that the development agenda would simply divert resources and attention from the real technical assistance needs especially of Africa. The transcripts of the meetings which are freely available on WIPO’s website confirm this.

The Development Friendly Option

By taking clear positions and focusing on the facts and ultimately ensuring the punishment of Wolfowitz, developing countries and civil society organisations made the World Bank a better place and a stronger institution. The truth is that much of the chorus from these groups was driven by the desire to get back at Wolfowitz for his anti-corruption crusade in their countries and to paint him as a hypocrite. But the motivations of the critics was not the issue on which the final decision turned. By sorting out the problem, the Bank was allowed to focus on its real job and the Secretariat and staff spared enormous agony. That is the development friendly option.

At WIPO, development friendly groups and developing countries must fully engage in the discussion about the behavior of Idris and seek to solve this matter speedily, based on facts. If the WIPO Secretariat wants to issue official documents such as the Brief note distributed to the General Assembly, then the report at issue should also be openly available. If in the end it means Kamil Idris stepping aside because he broke the rules and has become incapable of leading the organisation, then the cause of the Development Agenda will have been served. Only confident, corruption and scandal-free leadership at WIPO will lead to the proper and full implementation of the WIPO Development Agenda.

Of Trivialities and Falling Skies: A Look at Decision in the Novartis Case in India

2007-08-10T10:32:00.000+02:00

The skies are falling in India, literary! But that is because of the monsoons! However, if you have been listening to the spokespersons of Novartis and the IFPMA you might be forgiven to think that the skies are falling in India because a Madras High Court Bench rightly “laughed” Novartis out of court for three trivialities. First, the refusal by Novartis to accept that its drug Glivec could actually be a trivial invention per India’s law (a final affirmative finding is yet to be made on this). Second, the argument by Novartis that section 3(d) of the Indian Patent Act, 2005 violates the World Trade Organization Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS). And third, the idea that the said section is unconstitutional because it is arbitrary, illogical and vague since Parliament made no guidelines on what “enhancement of efficacy et al” means. In the media throughout the world no words have been spared to describe what happened, why and its significance. The 89 page decision is actually interesting reading, so if you have time read the whole thing.

Ruling in this highly publicised case, the learned High Court Justices dismissed, with no order as to costs, a petition by Novartis AG, the Basel based Swiss Company, and Novartis India Ltd, its Indian subsidiary to declare section 3(d) of the Indian Patent Act, 2005 non-compliant with TRIPS and Article 14 of the Indian Constitution. The judges clearly knowing they were being watched globally, delivered, not necessarily a classic, but a foolproof judgment. Health activists, generic companies, medical organisations, churches, and many others were obviously jubilant. But, even before reading the decision, Novartis in a press release posted on their website warned of falling skies. Charged the release: “A decision issued today in an Indian court will have long-term negative consequences for research and development into better medicines for patients in India and abroad.” The friends at IFPMA, the industry association, were not far behind. In their press release, IFPMA charged that: “The High Court in Chennai, India, has today dismissed a legal challenge to Section 3d in India’s 2005 Patent Law that seriously handicaps Indian patients, emerging research-based Indian and international pharmaceutical companies alike by discouraging development of innovative medicines.”

Novartis had argued that section 3(d) of the Indian Patent Act, 2005 did not comply with Article 27 of TRIPS as it was apparently discriminatory and was unconstitutional because it was arbitrary, illogical and vague. On the first ground, the Court, using basic international law principles, determined that in India, a dualist country in terms of its approach to international law, treaty law only became national law and capable of violation in India when specifically domesticated by the Indian parliament. By the same token it would follow that if the dispute was at the WTO India would not be permitted to argue in its defense simply that India’s parliament had decided to implement a TRIPS provision in a particular way or that its parliament had discretion. Indeed, in a ruling in 1998 in the India mailbox case the Panel told India as much.

In simple terms, the Court was telling Novartis that the TRIPS Agreement is not a source of law in India. You can only litigate in Indian courts violation of Indian law. The judges, politely and respectfully, reminded Novartis that if they had trouble with the Indian law vis-à-vis TRIPS what they needed to do was simple. Take a train or a drive or use any other forms of transport available in Switzerland from Basel to Bern (the Swiss seat of government) and convince the folks in Bern that India was violating the contract that the Swiss government entered into in 1994 to protect Novartis’s and other Swiss companies’ inventions in India (there have been some reports from India indicating that a Swiss official has indicated they will not move to WTO). If the folks in Bern were convinced and the Indian government did not agree to change (India trade Minister, Kamal Nath says India law if fully TRIPS consistent), the folks in Bern or their lawyers were free to take a ride or send a cable to Geneva (the seat of WTO) and “sue the pants off” the Indian government.

I am at a loss how this simple, clear and reasonable message will have long-term negative consequences for R&D or how it will handicap Indian patients or discourage development of innovative medicines.

But the Novartis and IFPMA statements confirm once again a widely known fact. The message send by the Madras High Court speaks to many similar situations in developing countries. The case of Thailand and Brazil recently, and South Africa and others before that where TRIPS is brandished to threaten, scare and confuse are just few obvious examples. One would have thought we moved on from here, how wrong!

On the second ground, the Court held that it was reasonable and scientifically possible to make a determination that “a new form of a known substance had resulted in the enhancement of the known efficacy of the original substance and the derivative so derived will not be the same substance since the properties of the derivatives differ significantly with regard to efficacy.” [p.58]. In sum the judges told Novartis that if it was the innovative company that it claims, and in relevant cases has proven to be, then they should be ashamed to claim that they do not know what enhancement of known efficacy means. With emphasis, the judges therefore agreed with the Additional Solicitor General of India and other Counsel who argued that a company of Novartis stature cannot plead that “they do not know what is meant by enhancement of a known efficacy and they cannot show that the derivatives differ significantly in properties with regard to efficacy.” In essence, section 3(d) of the Indian Patent Law, 2005 is Constitutional and is not arbitrary, illogical or vague. It is a reasonable exercise of legislative power by the Indian parliament taking into account the country’s interests and, in particular, the need to prevent evergreening and improve access to medicines.

There is no doubt that thousands, if not more pages will be written on this landmark decision. What should not be lost is that other than settling the two basic questions in dispute, the Court also made some memorable observations and restatements of the law. Just a few including some quoted from earlier decisions:

[P.25] “When domestic law is challenged on the ground of it being in violation of an International Treaty, domestic courts would have no jurisdiction.”

[p.34] “No declaration would be given where it would serve no useful purpose to the petitioner…Assuming that we give a declaration as prayed for, namely, the amended provision is not in the discharge of India’s obligation under Article 27 of “TRIPS”, even then, we fail to see for what use the petitioner can put it.”

[P.41] “ Therefore it would be unwise to fix any specific formula to be applied, as a matter of static measure, to find out whether the new form of a known substance resulted in the enhancement of the known efficacy or the derivatives differ significantly in properties with regard to efficacy.”

[P.44] “The speeches made by the members of the House in the course of the debate are not admissible as extrinsic aids to the interpretation of statutory provisions.”

[P.52] “What the patent applicant is expected to show is, how effective the new discovery made would be in healing a disease/having a good effect on the body? In other words, the patent applicant is definitely aware as to what is the “therapeutic effect” of the drug for which he had already got a patent and what is the difference between the therapeutic effect of the patented drug and the drug in respect of which the patent is asked for.”

[P.63]: “Parliament and the State Legislatures function best when they concern themselves with general principles, broad objectives and fundamental issues…”.

[P.70] “We reiterate here at this stage that the amended section with it’s Explanation is capable of being understood and worked out in a normal manner not only by the patent applicant but also the Patent Controller”

[P.75] “The possibility of flagrant abuse or misuse of law has never been a ground for holding a provision ultra vires.”

[P.76] “The Legislature has a duty to safeguard the economic interests of the country.”

[P. 80] “It must be presumed that the legislature understands and correctly appreciates the need of its own people, that its laws are directed to problems made manifest by experience and that its discriminations are based on adequate grounds.”

[P. 81] “ Therefore from the year 1948 or so the Parliament was aware about the change in economic conditions of the country, which made them change the 1911 enactment to suit the needs of the economic conditions of the country. Therefore there cannot be any doubt at all that the Patents Act as it stood then and as it stands today, is designed to safeguard the economic interests of this country and if that is so, the amended section must be viewed with greater latitude.”

[]P.88] “We have borne in mind the object which the amending Act wanted to achieve namely, to prevent evergreening; to provide easy access to the citizens of this country to life saving drugs and to discharge their Constitutional obligation of providing good health care to its citizens.”

WIPO Development Agenda - As the dust settles,pondering what is in the agenda, whether it is success or hot air

2007-07-09T01:10:00.000+02:00

On 26 August 2004, in a sleepy international Geneva; deep into the European summer, the Delegations of Argentina and Brazil in Geneva submitted a proposal for the Establishment of a Development Agenda for WIPO to be considered at the WIPO General Assembly scheduled for 27 September to 5 October 2004. This document was assigned WIPO document number WO/GA/31/11 and transmitted to other WIPO Member States. By the time of the General Assembly, one month later, 12 other countries, namely, Bolivia, Cuba, Dominican Republic, Ecuador, Egypt, Iran, Kenya, Peru, Sierra Leone, South Africa, Tanzania and Venezuela were co-sponsors of the proposal. The 14 countries together came to be known as the “Group of Friends of Development”. In October 2004 The WIPO General Assembly formally decided to discuss the establishment of a WIPO development agenda.

On 15 June 2007, approximately 34 months, three General Assemblies, three Inter-Sessional Intergovernmental Meetings on a WIPO Development Agenda (IIMs) and four Provisional Committee on Proposals Related to WIPO Development Agenda (PCDA) meetings WIPO Members finally agreed to establish a development agenda for WIPO. The agenda will be based on 45 recommendations covering issues and measures related to: technical assistance and capacity building; norm-setting; technology transfer, information and communications technologies (ICTs) and access to knowledge (A2K); assessment, evaluation and impact studies; institutional matters including the mandate and governance; and other issues. Though the WIPO General Assembly still has to approve the recommendations, the unanimous adoption of the recommendations at the Fourth PCDA suggests that, barring highly unusual surprises, this will be merely a formality.

In the beginning…

The initial seven page Argentina and Brazil proposal, based on the idea that development was the most important challenge facing the international community and that there was a development dimension that needed to be considered in intellectual property (IP) protection, sought important changes in a wide-range of WIPO’s activities and programmes including with respect to norm-setting; technology transfer, enforcement, technical assistance, and stakeholder participation in WIPO.

In the stampede to place on the table counter-proposals, stake ownership on the development agenda and in some cases plain obstructionism, WIPO ended up with 111 proposals by the 2006 General Assembly. Other proposals had come from the African Group, a group of Arab countries, Colombia, Chile, Mexico, the United States and the United Kingdom. Outside WIPO, the idea of a WIPO development agenda attracted unprecedented attention with discussions in conferences including a WIPO organised conference, the media, academic journals and on blogs. Highlights of events outside WIPO include the Geneva Declaration on the Future of WIPO and the draft Access to Knowledge Treaty.

From the beginning of the process I held the view that the proposal for the establishment of a development agenda and the process established thereafter to consider the form and content of a development agenda for WIPO, offered an unparalleled opportunity, especially for developing countries and public interest organisations, to place at the centre of the IP debate the question of the interrelation between IP and various facets of development. Other than various media comments, I have had occasion to write specifically on possible outcomes of the development agenda process. See, in particular, “Rethinking Innovation, Development and Intellectual Property in the UN: WIPO and beyond” – 2005 and “Essential Elements of a WIPO Development Agenda: What could Constitute Success?” (with Ron Marchant) – June 2007.

As the dust settles; What WIPO development agenda has been established?

The WIPO development agenda, as agreed at the Fourth Session of the PCDA, constitutes the issues and measures covered under the 45 recommendations that are being forwarded to the 2007 WIPO General Assembly in September/October. As per those recommendations, a WIPO development will entail: (a) significant reform of the WIPO technical assistance and capacity building programmes; (b) the establishment of a new development-based framework for norm-setting (treaty-making) activities; (c) consideration of access to knowledge and technology issues; (d) ramping-up WIPO focus and activities related to technology transfer; and (e) introducing a new evaluation and impact assessment framework in WIPO, among other measures.

The reform of WIPO’s technical assistance and capacity building programmes

Significant reforms are envisaged in this area whereby – Development considerations will be mainstreamed in assistance and capacity building programmes; The design, delivery and evaluation of assistance and capacity building programmes will be premised on specific principles including the principle of transparency and the principle that the level of development of each country has to be taken into account in implementing IP; there will be enhanced transparency through the publication of general technical assistance and capacity building programme information on the WIPO website in an accessible form, the provision of detailed information to Member States, on request and disclosure of information on technical assistance consultants coupled with stricter adherence and enforcement of the Code of Conduct; in the overall WIPO technical and capacity programme special attention will be paid to activities in Africa; in addition to the other issues that are addressed in the assistance and capacity building programmes, WIPO in its assistance programmes will also have to address issues of development-oriented IP education in academic institutions, the special needs of small and medium enterprises (SMEs), the interface between IP and competition, access to private patent databases by developing country IP offices, improvement of efficiency in IP offices in developing countries and ensuring that these offices promote balanced IP regimes, and flexibilities in the TRIPS Agreement; and through the creation of a database, specific efforts will be directed at matching IP-related development needs with available resources in and outside of WIPO.

What does this mean in practical terms?

While the implementation framework for all the 45 proposals is still being developed and some might argue that these recommendations do not mean much (the WIPO Secretariat could even argue that they have been doing all these), the reform introduced by the WIPO development agenda in this area of WIPO programming will mean at least three new things.

To start with, for the first time in WIPO’s history there will be an agreed general framework to guide the design, delivery and evaluation of activities in this area. A clear framework, established by Member States, will provide an important platform against which recipient countries, donor countries, academic researchers, critics, the media, civil society, industry and other stakeholders will critique and evaluate WIPO’s activities. Secondly, better transparency will inevitably lead to better accountability by the WIPO Secretariat to Member States in terms of efficiency in resource allocation and utilisation as well as impacts. Finally, this framework can help recipient countries better structure their requests to WIPO and in the long run will help increase the ownership and power of recipient countries vis-à-vis the WIPO Secretariat and other stakeholders in the design, delivery and evaluation phases of the programmes.

A new development-based framework for initiating, conducting and evaluating treaty-making and other norm-setting activities

The components of this new framework include: Mandatory Member-driven, open and balanced pre-negotiations consultations on proposed treaties or other norm-setting activities; a set of principles aimed at ensuring balanced, transparent and development-sensitive negotiation process and eventual treaties. The principles, among others include the principles that treaty-making will be Member-driven (avoiding Casablanca type conclaves), take into account the levels of development of different WIPO Members and the flexibilities contained in international IP agreements, especially flexibilities relevant to developing countries, and consider the costs and benefits of proposed treaties. The other components of the framework are continuing analysis of the implications of proposed treaties on the public domain, especially the need to ensure a rich and accessible public domain. Consideration would also be given to developing guidelines on the issue; dedicated focus on pro-competitive IP licensing practices; consideration in WIPO working documents related to proposed treaties of issues such as policy space in national implementation of IP rules, interface between IP and competition, transfer of technology, flexibilities, exceptions and limitations and special provisions for developing countries and LDCs.

The practical implications of this new framework for treaty-making and other norm-setting activities are manifold. For example, the mandatory pre-negotiation procedures will mean that there will be opportunity for more robust debate to clarify objectives, scope and content of proposed treaties than before. While this might mean that it will take longer before treaty formulation can begin, it will reduce incidences of complete breakdown such as in the recent cases of the proposed substantive patent law treaty (SPLT) and the broadcasting treaty after many years of discussions. On the other hand, the set of principles are likely to play an important role in increasing transparency of WIPO treaty-making as well as general accountability leading to the strengthening of WIPO and improvement in its legitimacy. This is a benefit for all WIPO Member States and other stakeholders.

Consideration of access to knowledge (A2K) and technology issues

The development agenda adopted at the Fourth Session of the PCDA will usher in a new Era for WIPO in terms of the scope of its issue coverage. Moving away from the earlier view that WIPO’s mandate was limited to simply promoting IP, the recommendations foresee dedicated discussions on access to knowledge and technology. It is also foreseen that WIPO Member States will exchange experiences on open collaborative projects such as the human genome project. These discussions and exchange of experiences have the potential to lead to new instruments or norms on issues of access to knowledge and technology to the benefit of developing countries, LDCs and the public, North and South. In other words, the WIPO development agenda has established a formal platform for the A2K movement to take forward a range of ideas from the proposed A2K treaty to discussions on alternative incentives and models for innovation. Coupled with the recommendations on the public domain, this recommendations mark a major shift in the philosophy and ideology of WIPO.

Technology Transfer

The development agenda includes a raft of recommendations on technology transfer, an issue hitherto viewed with disdain in WIPO. Among others, WIPO will now have to specifically: explore IP-related policies and initiatives necessary to promote transfer of technology and supportive measures that developed countries can take to promote transfer of technology from their territories; have specific discussions that could even lead to new instruments on transfer of technology in an appropriate body; undertake initiatives, subject to the agreement of Member States, that contribute to transfer of technology, for example, improving access to patent information.

The implications of the recommendations on transfer of technology is likely to include a necessary change of attitude by WIPO towards transfer of technology issues and an acknowledgement of the a key component of the organisations constitutional mandate. The dedicated work programme, if properly implemented, could help WIPO live-up to its responsibility in the UN system for facilitating transfer of technology to developing countries for socio-economic and cultural development.

A new evaluation and impact assessment framework for WIPO

Pursuant to the recommendations of the PCDA, a new evaluation and impact assessment will be introduced in WIPO for the first time in the organisations history. Under this framework, WIPO will be expected to develop an annual review and evaluation mechanism to assess the development-orientation of all its programmes and activities, including technical assistance and capacity building activities. The review and evaluation mechanism will contain specific benchmarks and indicators, as applicable. To undertake this work, WIPO’s capacity to perform objective assessments of the impact of the organization’s activities on development is to be strengthened.

This is a quantum-leap for WIPO. Though it is too early, to anticipate the real implications here since the mechanism is yet to be developed, there is no doubt that the establishment of annual evaluation and impact assessment mechanism heralds a new era for WIPO. In addition to all the other reforms envisaged under the development agenda, the evaluation mechanism is also likely to induce further reforms over time.

In addition to the annual review and evaluation mechanism across WIPO activities, a special review of all current WIPO technical assistance activities is to be undertaken in addition to, upon request by Member States, studies to assess the economic, social and cultural impact of IP systems in these countries as well as on the links and impact of IP on development. A study on the impact of IP in the informal economy is also to be undertaken.

Other Issues

There are a number of other issues which will also be addressed in the WIPO development agenda. These include: balanced approach to enforcement of IP in line with article 7 of the TRIPS Agreement; procedures for WIPO meetings outside Geneva; continued efforts to ensure wide participation of civil society organisations in WIPO activities; intensifying cooperation with other UN agencies such as UNCTAD, WHO, UNIDO, UNESCO; improving methods for finding partners to fund and execute projects; undertaking studies, appropriate on brain drain in Africa; addressing IP-related aspects of information and communication technologies (ICTs) including relevant issues relating to the digital divide; and enhanced exchanges and cooperation between research and scientific institutions in developed and developing countries.

Success or hot air?

An implementation machinery for the development agenda was also agreed at the Fourth session of the PCDA. This machinery is a Committee on Development and IP. The Committee will develop a detailed work programme for the implementation of the development agenda, monitor, assess, discuss and report, in coordination with other WIPO bodies, the implementation of the various recommendations constituting a development agenda for WIPO and discuss other relevant IP and development issues identified by the committees or decided by the General Assembly of WIPO. The Committee, whose first session is proposed for the first half of 2008, will report to the General Assembly annually.

The outcomes of the development agenda were received with jubilation across the political and economic spectrum among WIPO Member States and other stakeholders. An unnamed government official quoted by Intellectual Property (IP) Watch speaking of the outcome said, “This is a major achievement. It’s a complete overhaul of the WIPO concept, broadening it to reflect society’s growing concern with ownership of technologies and knowledge, and its effects for the future, both in developed and developing countries.” The Director General of WIPO, Kamil Idris, who is known not to have been amused by the initial proposal in 2004 said in a WIPO press release on 18 June 2007 that the outcome was “an important contribution to international efforts to promote the development of a balanced intellectual property system that is responsive to the needs and interests of all countries – developed and developing alike,”. Others who commented on the outcome like James Love argued that the outcomes meant that “WIPO is no longer only to pursue mindless expansions of intellectual property rights, but now is a place to discuss a broad range of topics, including measures to protect or promote access to knowledge, the implications and benefits of a rich and accessible public domain, and strategies for dealing with abuses of rights, or other measures to protect the public interest.”

The results are clearly beyond the dreams of the initiators of the discussions and pretty much everyone else who witnessed the atmosphere, the discussions and other antics in WIPO in 2004.

From the very beginning of this process, however, sceptics have argued that the proposal for the establishment of a development agenda amounted to nothing more than hot air, ideology and empty rhetoric. So far the sceptics have been proven wrong. The range of reforms and new frameworks envisaged under the now established development agenda are anything but hot air, ideology and empty rhetoric. Although like everything else implementation might entail significant challenges and failure could visit the agenda, as the dust settles, it is becoming clear that the development agenda for WIPO has the potential to significantly transform the organisation in major ways resulting in not only improvements in the attention paid to development issues and the composition of its staff but also to deliver the organisation into the 21st Century. For this reason, the development agenda is already a success. The challenge that remains is to build on this success and ensure that the opportunity is not squandered in implementation. A lot of work remains to make the agenda a reality on the ground. Sustained interest and vigilance by both governments and non-governmental actors, especially civil society, continued political commitment and critique will be crucial going forward.