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Making the case for strong intellectual property rights in Chile and Latin America

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For countries like Chile looking to reduce dependence on the export of natural resources, innovation will be key. Knowledge-based industries from life sciences to film form the basis of economic growth in most OECD countries, their growth and investment encouraged by a strong framework of intellectual property rights.

Latin American countries such as Chile hold much promise due to their biodiversity, good science base and entrepreneurial citizens. Yet there is scepticism in policymaking circles in Chile and elsewhere in Latin America about the potential of innovation, and role of intellectual property rights, in particular in debates about public health. This most recently has manifested itself in attempts to by the legislature undermine intellectual property rights by making it easier to issue a compulsory license for medicines.

This was the backdrop to a one day dialogue of regional think tanks on innovation and development, convened by Geneva Network hosted in the offices of Centro de Estudios Publicos in Santiago, Chile.

Thinkers and experts from thirteen international, pro-market think tanks came together to give their perspectives on these important issues. Represented organisations included Libertad y Progreso (Argentina), MacDonald-Laurier Institute (Canada), Libertad y Desarrollo (Chile), Fundacion Eleutra (Honduras), Information Technology and Innovation Foundation (USA) and Instituto de Ciencia Politica (Colombia).

Among the conclusions of the day:

  • Latin America will need to prioritise innovation if it is to meet its social, demographic and economic challenges.
  • In an era of globalization in which knowledge-based industries form the bedrock of the most successful economies, intellectual property rights (IPRs) must be considered as fundamental market institutions, alongside physical property rights and the rule of law. By contrast, government attempts to co-opt IPRs through for example compulsory licenses create enormous uncertainty for domestic and international investors.
  • Strengthening domestic intellectual property rights is often viewed as a “cost” of trading with wealthier countries, to be resisted or watered-down. It is, in fact, necessary to meaningfully participate in an increasingly knowledge-based global economy.
  • As knowledge-based goods and services are an increasingly important component of global trade, policymakers should look to the trading system to create a level playing field and high standards of protection.

Clearly, enormous challenges remain if Latin American countries are to become more innovative and participate more meaningfully in global value chains and international innovation networks. But the opportunity is there: it is up to the current generation of policymakers to seize it.

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Panel discussion at the World Trade Organization: IP as a Driver for Innovation

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The U.S. Mission Geneva cosponsored today’s discussion on IP as a driver for Innovation at the WTO (World Trade Organization). A panel of four expert speakers looked at how IP incentivizes creativity in the arts, business and technology, unshackling human potential to address the world’s many challenges. The event featured four speakers: Carsten Fink, Chief Economist of the World Intellectual Property Organization, Dr. Keith Nurse, Senior Fellow at the University of the West Indies and founder of the CaribbeanTales incubator, Dr. Jonas Pollard, head of the Hemolytics project at the Adolphe Merkle Institute, and Jason Kang, CEO and Co-Founder of Kinnos. The session was moderated by Philip Stevens, Director of Geneva Network.

To see photos from the event click here.

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Indian thought leaders’ policy dialogue on health, innovation and competitiveness

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In the run up to the 2019 general election, the Indian government has prioritised healthcare delivery and promoting innovation and competitiveness in the country, including in the health and life sciences sector.

To feed into this discussion, Geneva Network organised a half day roundtable in Mumbai to assess the state of play, and also to brainstorm policy reforms that could accelerate progress. The roundtable included 15 thought leaders from Indian think tanks, universities and NGOs, in addition to participation from around 20 individuals from the private sector.

The first panel, moderated by Ali Mehdi of the Indian Council for Research on International Economic Relations (ICRIER), looked at the status of the newly launched Ayushman Bharat scheme, with a particular focus on how the private sector can partner with the government to ensure the success of the scheme.

The second panel, moderated by Aman Gupta of Strategic Partners Group, examined the reforms necessary to make India a leading life science investment destination and to promote innovation within the country. The discussion focused on intellectual property reforms, regulation and trade policy, with a particular reference to the lessons from China’s policy reforms.

The outputs of the discussion will be released as a white paper co-published by Invest India, Institute for Competitiveness India and Geneva Network, for distribution to Indian government stakeholders.

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Malaysian Roundtable on Innovation and Access to Medicines

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Galen Centre’s Azrul Mohd Khalib gives an overview of Malaysia’s Government Use License

In 2017 the Malaysian government issued a Government Use License for a Hepatitis C medicine. Following the recent change of government, Geneva Network in collaboration with local partner the Galen Centre organised a half day round table to assess the impact of this policy and to emphasise the important role of intellectual property rights in facilitating access to, and innovation of, new medicines.

Geneva Network’s Philip Stevens began the day by outling the linkages between innovation, IP and economic development, followed by Azrul Mohd Khalib’s, of the Galen Centre, overview of the timeline of the government use license and its negative impact on various international IP and innovation rankings. This theme was further explored by Chew Phye Keat, past president of the Malaysian Intellectual Property Association, who emphasised the need for predictability and transparency in the deployment of flexibilities in IP law, which is arguably lacking in the Malaysian context.

The Geneva Network delegation visits the Institute of Strategic and International Studies (ISIS) Malaysia

Prof. Mark Shchultz of Southern Illinois Law School explained the important role of IP in protecting the market-building investments necessary to launch a medicine in a new country, while Indonesia’s Widya Wihardijono emphasised the importance of IP to pharmaceutical innovation. Ong Mei Ching of cancer access charity, the Max Foundation, concluded by explaining the complexity of getting drugs to patients, particularly in resource-poor settings in Asia.

During the visit to Kuala Lumpur, Philip Stevens of Geneva Network, Azrul Mohd Khalib and Prof. Shcultz also visited the offices of local stakeholders to share views on Malaysian innovation, access and trade issues.

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Geneva Summit for pro-innovation thought leaders and think tanks

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WIPO DG Francis Gurry makes introductory remarks, next to Geneva Network’s Philip Stevens

As WHO member states gathered in Geneva for the 2018 World Health Assembly, Geneva Network co-ordinated a summit for pro-innovation think tanks and thought leaders from around the world. Thanks are due to the World Intellectual Property Organisation which kindly offered meeting facilities and lunch in its headquarters building.

WIPO Director General Francis Gurry started the day with an overview of the main challenges and opportunities facing the global IP system, and subsequent panelists discussed, amongst other topics, the role of IP in facilitating investment and economic development; the real barriers to access to medicines; IP-related developments in the global trading system, including NAFTA; and a discussion of how IP is being used by entrepreneurs in developing countries to fulfil unmet health needs. While in Geneva, some participants met with country missions to discuss how best to advance pro-innovation policies at the World Health Assembly.

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Civil society statement on the EU’s intellectual property incentives review

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Following growing concern about the sustainability of healthcare systems, in the summer of 2016 EU Health Ministers invited the European Commission (EC) to undertake a review of the Intellectual Property (IP) incentives that underpin biomedical innovation.

This document is a joint statement by a coalition of like-minded  think tanks, civil society groups and academics who believe that Europe’s future prosperity is best secured through open markets and strong respect for property rights (including intellectual property rights), underpinned by the rule of law.

Our statement makes two key points.

First, innovation is of paramount importance to Europe’s future economic growth, and by extension, living standards. Yet EU member states underspend on Research and Development (R&D) and are outperformed on a host of innovation measures by peer nations such as the United States, Japan, South Korea and Australia, according to the 2017 European Innovation Scorecard. The incentives review must therefore focus on boosting EU innovation.

Second, European societies are ageing and there is an urgent need for new technological solutions to mitigate the economic and fiscal effects. In particular, there is a growing need for new medicines against diseases that are prevalent among older people, such as neurological conditions and cancer. European companies are making some progress, but research into these diseases is complex, financially risky and extremely slow moving. The EC’s review must therefore preserve the delicate innovation ecosystem that underpins continued private sector investment into these diseases.

Read the statement

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South Africa’s journey to a knowledge economy: progress and challenges

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Prof Sarjiker stresses the importances of well crafted IP legislation for economic development

For South Africa to join the ranks of high-income countries in the longer term it needs to start building a knowledge economy. That means ensuring its frameworks for the protection of intellectual property are of the highest standard, to attract international investment and know-how, and provide certainty to local innovators.

South Africa’s journey to a knowledge economy was the theme of a half day symposium in Johannesburg, co-hosted by Geneva Network and the Free Market Foundation of Southern Africa, attended by a wide range of stakeholders from the private and public sector, academia and the media.

The keynote was delivered by Prof Sadulla Sarjiker, professor of law at Stellenbosch University. Prof Sarjiker shared his concerns about the quality of the draft amendments to the copyright act, which he argued would inflict serious damage on local knowledge industries and scare off foreign investment.

Patrick Kilbride of the Global Intellectual Property Center presented the 2017 edition of its International IP Index. The index benchmarks IP-related laws and their enforcement across 45 countries, allowing policymakers to compare the quality of their institutions with peer countries. South Africa’s entry is here.

Prof Kelly Chibale of the University of Cape Town gave an overview of the importance of IP in his drug development work. IP, he argued, gives certainty to all the disparate players in drug development and commercialisation, while ensuring high standards and quality in manufacturing.

Jetane Charsley of the National IP Management Office stressed the importance of IP for the commercialisation of publicly-funded innovations. South Africa has for some years had technology transfer legislation modelled on the US Bayh Dole Act which has helped both South African universities and companies deliver several useful new products to consumers.

Above all, participants stressed the huge innovative potential of its people. South Africans can drive the country’s transformation to a knowledge economy, but it needs the right policy environment to unlock that potential. A strong framework of intellectual property rights is fundamental.

Many thanks to the Free Market Foundation for their excellent organisation of the event.

 

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Pro-innovation civil society groups gather in New York to talk global health

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The debate around innovation and health has been monopolised over the last decade by civil society groups that claim the current system of drug development, underpinned by markets and intellectual property rights, does not function and must be replaced by alternative systems that envisage a far greater role for government.

In reality, there is no such consensus amongst civil society, not least because of the substantial body of empirical evidence indicating the contrary.

Last week in New York, Geneva Network was proud to convene a meeting of representatives from 13 pro-innovation think tanks and NGOs from around the world, to map out a research agenda that explores the important role of property rights and markets in innovation and health.

These pro-market civil society groups are united in their support for all forms of property rights – including intellectual property rights – as the bedrock of prosperity and innovation.

The think tanks were drawn from all over the globe, including organisations from Mexico, South Africa, Malaysia and Italy.

During the discussions, participants identified a number of areas for research which could support more evidence-based policymaking in this area:

  • Does the protection of intellectual property rights improve development indicators at the national level, such as health and income?
  • How has free trade assisted in the global diffusion of health-improving ideas and technologies?
  • What are the real barriers to access to medicines in lower and middle-income countries?

The group’s research over the coming months will shed light on these and other questions, making an important contribution to the policymaking process.

Stay tuned for updates at the twitter hashtag #innovate4health.

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Comment faciliter l’accès aux médicaments en Afrique du Sud? Geneva Network in Afrik.com

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Alors que les populations sud africaines ont un besoin cruel de médicaments, les nouveaux médicaments ont un mal fou à pénétrer le marché du pays. Pourquoi ? Dans leur article, Urbach et Stevens, dénoncent la lourdeur de la réglementation sud africaine qui entrave lourdement la mise sur le marché de nouveaux médicaments. Les démarchent peuvent prendre 2 ans pour les médicaments prioritaires et peuvent aller jusqu’à 38 mois pour les autres. Les raisons sont nombreuses dont le manque de ressources humaines. Les auteurs suggèrent alors de s’appuyer sur les résultats des contrôles faits par d’autres pays crédibles pour la mise sur le marché du médicament concerné. Cela éviterait de tout reprendre à zéro et réduirait à la fois les délais et les coûts. Les bénéficiaires seront avant tout les malades !

De nombreux problèmes gangrènent le secteur de la santé en Afrique du Sud. L’un des plus frustrants est l’incapacité du régulateur du marché des médicaments, le « Medicines Control Council » (MCC) à homologuer les médicaments en temps opportun. Cette inertie bureaucratique prive des milliers de patients sud-africains d’un accès facile aux médicaments. Pour les patients atteints du cancer et du VIH, ces retards pourraient même être mortels.
Dans presque tous les pays, les autorités, avant la mise sur le marché d’un médicament, font des tests pour vérifier l’efficacité et la sureté. Malheureusement en raison du fait de la lourdeur des procédures, les médicaments déjà approuvés dans d’autres pays, trainent à faire leur entrée sur le marché sud africain.

Les données du ministère de la Santé montrent que l’homologation prend en moyenne 37 mois pour un médicament générique et 38 mois pour un nouveau médicament. Selon les chiffres du gouvernement, seulement 70% des nouveaux médicaments ciblés par l’examen accéléré prioritaire (Cancer, VIH, médicaments contre la tuberculose et vaccins), sont approuvés dans les deux ans. Ces délais sont déprimants pour les malades dans l’attente.

Comment expliquer cela ? D’abord, le manque de ressources humaines est clairement un facteur déterminant. Une autre raison est que le gouvernement a une politique pro-générique pour permettre d’accroitre l’accès à des médicaments à prix abordables. Cette loi oblige à privilégier les importations des médicaments les moins coûteux au détriment d’autres médicaments. Sans surprise, la réforme a conduit à une explosion des demandes d’enregistrement par les fabricants de génériques, soit plus de 2 500 entre 2007 et 2012, selon des chercheurs de l’Université du Cap-Occidental. Les maigres ressources de le MCC ont déjà été englouties et il continue de lutter contre l’afflux ininterrompu des demandes.

Une solution à ce problème de capacité est que le MMC ne tente pas de mener l’ensemble du processus d’examen lui-même, mais plutôt de s’appuyer sur le travail des plus grands régulateurs de médicaments étrangers qui sont mieux dotés en termes de moyens. Cela permettrait d’éviter les doubles emplois, d’économiser l’argent public et d’accélérer l’accès aux médicaments.

L’année dernière, un responsable du MMC, le Dr Joey Gouws, a déclaré, lors d’une conférence internationale des régulateurs des médicaments au Cap, qu’il est nécessaire de coordonner les actions de son service avec celles de la Food and Drug Administration (FDA). Au lieu d’allonger la chaine des autorisations de mise sur le marché, il faudrait une convergence règlementaire qui permettrait aux petits pays d’économiser de l’argent et de gagner du temps en s’appuyant davantage sur le jugement d’experts des grands organismes de réglementation.

Actuellement, selon le Dr Gouws, il n’y a pas de convergence réglementaire entre l’Afrique du Sud et les autres pays, ce qui signifie que les régulateurs ne partagent même pas avec l’Afrique du Sud les rapports sur les médicaments déjà examinés. Cependant, signe encourageant, il est prévu qu’en avril, le MCC devienne l’Agence sud-africaine de réglementation des produits de santé, avec une nouvelle législation permettant le partage d’informations avec d’autres organismes.

Le MCC a déjà signé des mémorandums d’accord avec la Suisse et le Royaume-Uni comme pays de référence dans le processus d’approbation des médicaments. D’autres accords en cours d’élaboration sont conclus avec l’Organisation mondiale de la santé pour les médicaments prioritaires ; avec le Brésil pour les dispositifs médicaux ; et la Chine pour les ingrédients pharmaceutiques actifs.

Ce partage d’informations serait une étape importante. Mais il ne faudrait pas s’arrêter là. A ce propos, l’exemple de l’Arabie Saoudite et de l’Egypte pourrait être inspirant : les deux pays ont introduit, début 2017, de nouveaux systèmes d’homologation des médicaments qui font référence aux décisions prises par la FDA aux États-Unis. Ces réformes feront passer les délais actuels, d’ autorisation de mise sur le marché, de 12-36 mois à 1 ou 2 mois, soit une réduction de plus de 90%. Une aubaine pour les patients !

Pour les pays à revenu intermédiaire qui se débattent sous des charges multiples en matière de santé et qui ont des ressources limitées, il s’agit d’une réforme sensible et sans frais qui sauverait des vies. Voici une initiative que nous devrions imiter en Afrique du Sud.

Urbach est analyste pour The Free Market Foundation, et Stevens est directeur de Geneva Network.

Article publié en collaboration avec Libre Afrique.