IPWatchdog covers recent Geneva Network report
Eileen McDermott quoted from our recent report on ‘Will the USMCA’s Requirements on Regulatory Data Protection increase spending on Medicines’ in an article at IPWatchdog.
Geneva Network at the 2019 Summit of the Global Trade and Innovation Policy Alliance
Philip Stevens represented Geneva Network at the 2019 Summit of the GTIPA in Mexico City, joining representatives from 25 think tanks from around the world.
On the agenda:
- Smart cities and society
- The impact on innovation and intellectual property on the USMCA and the EU-Mexico Modernised Trade Agreement
- Technology-driven transformation changing business models and global trade
- Challenges and opportunities for developing countries regarding life-sciences innovation
- The Fourth Industrial Revolution and the Sustainable Development Goals
Thanks to Fundacion IDEA and the Information Technology and Innovation Foundation for hosting.
Geneva Network and IDEAS joint roundtable on IP reform in Malaysia
Geneva Network and IDEAS joint roundtable on IP reform in Malaysia was profiled in Free Malaysia Today.Kyungjin Song, chairman of the International Cooperation, Innovative Economy Forum of South Korea, told the meeting that the IP industry had spurred her country’s economic growth. She said between 2010 and 2015, about 30% of Koreans worked in the IP sector and earned 50% more than those in the non-IP industry.
Geneva Network research quoted in IPWatchdog
Geneva Network research is quoted in this IPWatchdog article examining whether the IP provisions in the USMCA will raise medicine prices.
Civil society statement on the EU’s intellectual property incentives review
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
Comment faciliter l’accès aux médicaments en Afrique du Sud? Geneva Network in Afrik.com
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.
Geneva Network director Philip Stevens talks to the Malay Mail about prospects for the new dengue vaccine
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.
Azrul Mohd Khalib, senior manager of external relations with IDEAS, says the government can concentrate the use of the vaccine in hotspots, Kuala Lumpur, October 22, 2016. ― Picture by Choo Choy May
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.
Geneva Network statement on UN High Level Panel on Access to Medicines
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
Fact-checking the campaigns for and against the TPP trade deal
Our research on the impact of increased periods of data exclusivity in Japan and Canada on pharmaceutical spending is mentioned in this Washington Post article.
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