Original news and analysis on international IP policy
[From the Washington Post] BOGOTA, Colombia — Colombia’s government is giving pharmaceutical giant Novartis a few weeks to lower prices on a popular cancer drug or see its monopoly on production of the medicine broken and competition thrown open to generic rivals.
CAPE TOWN, South Africa — Plain packaging is considered unattractive among marketers, loss-making for industries, and a healthy life promoter for governments and the public. The potent mix to balance profits, safeguard jobs and cut illnesses has made it a controversial solution to curb smoking. As it grows in popularity around the world, how is plain packaging faring in Africa?
In the light of the UN High-Level Panel on Access to Medicines, this series of sponsored articles challenges experts to give their views on the policies that best support the development of solutions to societies’ greatest challenges and how enabling policy environments, including IP systems, influence the development and flow of new technologies and services in different sectors, fields of technology, and jurisdictions. The views expressed in the articles are those of the authors. Below is an interview with David Taylor, Professor of Pharmaceutical and Public Health Policy, University College London, UK.
Next week the annual assembly of World Health Organization member states will take place with a heavy agenda and its largest attendance ever. The lack of new antibiotics to address bacterial resistance, global shortages of vaccines and medicines, the fight against substandard drugs, and a framework to guard against undue influence of outside actors on the work of the WHO are part of a picture where there is an increasing blur between developed and developing countries in terms of access to medicines. And then there is the matter of electing a new WHO director general.
At its annual Assembly next week, the World Health Organization will seek member state approval of US$160 million over two years to establish its role as a global coordinator for health emergencies. Image Credits: UN
Article 58, a process introduced by the European Commission to help speed up the time low and middle-income countries take to approve new drugs, could be in for a massive overhaul. A revamp has been proposed because it is underused - just a handful of products have gone through the Article 58 process since its launch in 2004. The most recent is an antiseptic chlorhexidine gel that prevents new-born umbilical cord infections in developing countries. A joint project between GSK and Save the Children, it was approved late last month.
The Indian government today released its long-awaited new intellectual property policy, and preliminary reactions appear to be that it caters to international pressures while attempting to provide a national focus. A more careful reading with reactions will follow.
Public health advocates last week told World Health Organization delegates they must act quickly to save the lives of poor populations suffering from less common diseases for which there is no research and development funding. Nongovernmental organisations showed up to a WHO meeting on the issue to urge on delegates, even holding a public demonstration in front of the UN, but there was concern afterward at the little progress made.
A copy of the new Indian patent office order shows the details of the decision to reverse an earlier direction and grant a patent in India on the high-value hepatitis C drug. [Updated with response from Gilead]
A number of World Health Organization member states attended a meeting last week aimed finding ways to sustainably finance research and development for medical products, especially those for poor populations lacking means to pay high prices. According to the outcome document and a WHO official, they heard many viewpoints from experts and made progress but much was left for the World Health Assembly later this month.
Médecins Sans Frontières (MSF, Doctor Without Borders) today announced a report detailing what it calls failings in the current system for developing new drugs in ways that all patients can afford and access, and providing proposed policy options for addressing the problems.
[story updated] Biosimilar drugs hold out big opportunities for India’s drug companies. But the future is fraught with challenges. One key challenge is regulations.
What does this mean for countries like India, an emerging market for biosimilars? How will the evolving global regulatory environment on biosimilars impact patients?
Last month, both these questions came to the fore as the battle over biosimilars moved centre stage in this country in the wake of an interim order by the Delhi High Court, and then another decision by a Division Bench of the same court which took a different view.