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.
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.
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.
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 !
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.
Editor’s Note: This article first appeared in The MalayMail Online on 25th October 2016
Think tanks: Dengue Vaccine can save half of Malaysia’s RM735m dengue cost
PETALING JAYA, Oct 25 ― Two think tanks argue that Malaysia can half the estimated US$175.7 million (RM735.3 million) economic burden of dengue if it approves a vaccine.
Philip Stevens, director of UK-based public policy research organisation Geneva Network, pointed out that dengue cases have been rising in Malaysia, which shows that fogging and larvicide are not working.
“The vaccine could reduce the economic burden,” Stevens told Malay Mail Online in an interview here.
He added that although he estimated at least 50 per cent savings if the dengue vaccine is used in Malaysia, he could not give exact figures because it’s unknown how much the vaccine would be priced here.
Stevens cited a 2015 study by Universiti Malaya, the Health Ministry and US-based Brandeis University that estimated the cost of dengue in Malaysia at US$175.7 million a year, comprising the cost of illness (medical costs and productivity loss from illness and death) and the cost of prevention activities, mostly fogging.
The study had found that Malaysia spent US$73.5 million, or 0.03 per cent of the country’s GDP, on its national dengue vector control programme in 2010, and cited a previous research which put the annual cost of dengue illness in Malaysia at US$102.2 million in 2009, totalling an estimated US$175.7 million.
Earlier this month, Singapore approved ― for people aged between 12 and 45 ― the use of Dengvaxia, the world’s first licensed dengue vaccine developed by Sanofi Pasteur that provides immunisation against all four virus strains.
It is also approved for use in nine other countries including Thailand, Indonesia, the Philippines, Brazil and Mexico, according to Singapore’s Channel News Asia.
Singapore’s Health Sciences Authority said that Dengvaxia had an efficacy rate of 60 per cent against dengue and 84 per cent against severe dengue, according to a review of 24 clinical studies run by French pharmaceutical company Sanofi, including two major trials in Asia and Latin America comprising over 35,000 participants.
However, Malaysia has yet to approve the dengue vaccine, purportedly for safety reasons, despite the rise of cases and deaths from the Aedes mosquito-borne disease.
Stevens cited Health Ministry statistics that showed an increase of dengue cases from 43,346 in 2013 to 120,836 last year, with deaths rising from 92 to 336 in the same period.
A total of 71,590 dengue cases were reported from January 1 to August 20 this year, Health Ministry director-general Datuk Dr Noor Hisham Abdullah reportedly said.
Stevens argued that vaccines are the most cost-effective public health intervention and said Putrajaya’s reluctance to approve the dengue vaccine was sending mixed signals to the business community.
“It sends a signal that innovative products are not welcome here,” he said.
Dengue vaccine can be concentrated in Klang Valley
Azrul Mohd Khalib, senior manager of external relations with local libertarian think tank, Institute for Democracy and Economic Affairs (IDEAS), said Malaysians have the right to make their own decisions to get immunised.
“The government is posing a barrier to people’s right to protect themselves,” Azrul said at the joint interview with Stevens, who is also an IDEAS Senior Fellow.
He said the dengue vaccine in the Philippines is priced at RM300 per person for all three doses.
Azrul added that Malaysians and private companies could pay to vaccinate themselves and their employees if the government could not afford to subsidise the vaccine.
“Also, the government can concentrate their efforts on concentrated epidemic areas, such as the Klang Valley where 60 per cent of cases are located. No need for a national vaccination programme to start with,” he said.
He also pointed out that Malaysia was involved two years ago in clinical trials for Dengvaxia and that the government had said it wanted Malaysia to be the first country to adopt the vaccine.
“Today, it’s very strange why Malaysia is attacking the results of the trial it participated in,” said Azrul. “We want the Ministry of Health to be more transparent.”
He also warned the government that it would be harder for Malaysia to negotiate a good deal for the vaccine with each year of delay.
“There is a worry that Malaysia is waiting for the perfect vaccine. Experts will tell you it’s very rare for 100 per cent efficacy,” said Azrul. “I don’t think we can afford to wait.”
Health Ministry has Malaysia dengue vaccine safety concerns
Health DG Dr Noor Hisham said the ministry still has concerns about Dengvaxia and is in the process of reviewing the vaccine, but did not give a timeline for the review process.
“It’s not the issue of perfect, but the issue of safety. Safety and perfect [are] not equal,” Dr Noor Hisham told Malay Mail Online.
He cited a September 2016 study by Johns Hopkins University, Imperial College London and the University of Florida that found that while the vaccine could reduce illness and hospitalisation by 20 to 30 per cent in dengue hotspots, they could be significantly increased if the vaccine is used in locations with lower transmission of the virus.
The study noted that Dengvaxia manufacturers have acknowledged that the vaccine doesn’t work well on those who haven’t been previously infected with dengue before vaccination.
The World Health Organization (WHO) has recommended that countries consider introducing the vaccine only in areas with a “high burden of disease.”
“Dengue vaccine introduction should be a part of a comprehensive dengue control strategy, including well-executed and sustained vector control, evidence-based best practices for clinical care for all patients with dengue illness, and strong dengue surveillance,” said WHO in its position paper.
The UN High Level Report on Access to medicines threatens the nascent boom in biopharmaceutical R&D in middle-income such as India and China, according to Geneva Network, a UK-based research organisation working on international trade, health and intellectual property issues.
Since China and India upgraded their protection for intellectual property in the mid 2000s, their private sectors have committed ever-greater sums to R&D, and carved out new niches in biopharmaceutical innovation, often in collaboration with international partners.
The UNHLP threatens to derail this important development.
The overall thrust of the UNHLP’s recommendations is to weaken IPRs. This fails to take account of modern ways in which biopharma R&D is conducted, and the importance of IP in the process.
Innovation no longer starts and finishes inside one ‘vertically-integrated’ pharmaceutical company. Now, big biopharmaceutical companies collaborate with small companies, academia and the public sector at all stages of the R&D cycle, often across borders.
Sharing valuable knowledge is the basis of this new, networked innovation model. Strong global IP rules are fundamental, as they provide the legal framework that allows valuable knowledge to be safely shared.
Without IP, Asian researchers, entrepreneurs and companies would be unable to participate in a meaningful way.
By turning the clock back to the pre-TRIPS era, the UNHLP would cut India and China off from the new world of networked innovation; smaller countries in Africa, Latin America and Asia would not even get a foothold.
That is not conducive to economic development, or the future needs of patients.
For further details please contact info -at- geneva-network.com
Countries need to commit to abolishing import tariffs on drugs
Geneva, September 29, 2015 ─ A new study from Geneva Network has found that the global volume of trade in medicines that have their price increased by tariffs is growing at 21% per year.
This means more patients in countries such as India, Brazil, Pakistan and Russia have to pay more for medicines, as a result of government import duties.
The study, called “Pharmaceutical tariffs, trade flows and emerging economies” is launched by Geneva Network today at the World Trade Organization Public Forum in Geneva.
“Tariffs on medicines are a regressive form of taxation, as they take a higher proportion of income from the poor than they do for those higher up the income scale,” said study co-author Nilanjan Banik. “If the goal is to make medicines more affordable for those who need to buy them then Governments should abolish all tariffs on medicines.”
The study also finds that a number of countries impose average tariffs on medicines of over 8 per cent. These include the Russian Federation (10.2%), India (10%), Uruguay (9.9%), Argentina (9.8%), Brazil (9.8%) and Thailand (9.3%).
Nepal has the highest tariffs on medicines in the world, standing at 14.6% on average.
The vast majority of high-income countries and many of the poorest countries do not levy tariffs on pharmaceuticals.
Many countries apply tariffs only on a few categories of medicines. However, Uruguay, Paraguay, Argentina, Brazil, India, Mexico, and Morocco apply them to over 70 different categories: 158 in the case of Uruguay.
Vaccines are widely recognised as one of the most cost-effective and important health interventions. The study finds that few countries apply tariffs to vaccines. However, India, Ghana and DR Congo have the highest levels, applying them at an average level 10 per cent.
Study co-author Philip Stevens said “Vaccines are vital for preventing disease and suffering, particularly amongst children. There are a number of important steps which need to be taken to achieve universal coverage and if countries like India abolish tariffs on imported vaccines, this would constitute one of those steps”.
What’s happened in the first six months of Geneva Network – new studies on IP, health and trade.
Geneva Network co-hosted its first event on 21 May, in Singapore, with our friends at SEANET. The aim was to cast some light over the debate about TPP and health, which so far has been rather apocalyptic.
Prof Elizabeth Ng of the National University of Singapore kicked off by giving some context around the TPP, citing data showing the relative levels of medical innovation that occurs in each TPP country and outlining the various arguments for and against the likely IP components. She also raised the question of how the new IP requirements of TPP will fit into the existing constellation of trade deals in the ASEAN region.
Philip Stevens of the Geneva Network then set out some of the likely impacts of the TPP on health, citing his research showing that trade liberalization has historically driven up health outcomes, as it accelerates economic growth and the transfer of knowledge and technologies related to health. He also addressed some of the more alarmist predictions that have been circulating in the media about the IP aspects of TPP.
From the patient side, Andrew Spiegel of the Global Colon Cancer Association gave examples of the transformative effect new biologic medicines have had for sufferers for this disease. Bill Claxton of Singapore’s Carcinoid and Neuroendrocrine Tumor Society talked about the importance of innovation for sufferers of rare diseases, and patients’ needs for early access to new medicines.
From the pharmaceutical industry perspective, Mo Mayrides of PhRMA argued the importance of data exclusivity provisions being proposed in TPP for innovation in biologics. A sufficient period of data exclusivity, he argued, is vital for securing investment in this high-risk field of research and development because of the ease with which patents can be worked around.
Our thanks go to Debbi Helms of the Asian Trade Centre who made a fantastic moderator.