Original news and analysis on international IP policy
The leaders of India and the European Council today in Brussels discussed a wide range of topics including intellectual property rights - including geographical indications - innovation, digital issues, and health and pharmaceuticals.
A research group announced in March that it has designed the first minimal synthetic bacterial cell. Rapid advances in science seem to be leaving the international normative process lagging behind. Current international instruments are seeking to understand how this new technology will impact their regulatory efforts, while civil society raises high concerns.
The World Health Organization has released a report on the role of intellectual property in local production of medicines in developing countries. According to the report, the way countries design their intellectual property system is key in the development of local innovation and production. However, health outcomes will depend on the accessibility and affordability of good-quality essential medicines.
Biotherapeutic medicines, engineered by living organisms, have opened a promising path to treat major diseases. Near copies of these medicines, called biosimilars, are slowly coming to market, as the originator products become free of intellectual property rights or data protection.
However, some regulatory issues are left to be addressed, in particular in developing countries, according to the pharmaceutical industry and the World Health Organization. For patients, information on those products and their affordability are key, said a patient group representative.
That the Indian government has been under pressure from the United States to change its patent regime is no secret among those who follow the public discourse on intellectual property rights. Now, a new controversy about India’s alleged private assurance to the US-India Business Council (USIBC) and other lobby groups that it would not invoke compulsory licensing for commercial purposes seeks to add fuel to fiery speculation about a shift in India’s policy on IPR.
Public health advocates, academics, patients, governments and others this week presented further ideas to the United Nations Secretary-General’s High-Level Panel on Access to Medicines on ways to break the longstanding pattern of expensive medical products around the world as a way to pay for research and development.
The World Trade Organization said today that momentum continues to build among member states to accept a public health amendment to the WTO intellectual property rights agreement, as three more countries adopted it in the past week.
Speakers from Asian civil society provided recommendations to the public hearing of the United Nations Secretary General’s High-Level Panel on Access to Medicines held yesterday. They underlined the unaffordability of medicines in their countries, the inefficiency of current mechanisms such as voluntary licensing, and the pressure applied by pharmaceutical companies and the United States and Europe to prevent the use of compulsory licences. One speaker warned against the expert advice given by the World Intellectual Property Organization to least-developed countries, while others pointed to stringent intellectual property measures in free-trade agreements.
Today in Johannesburg, South Africa, the second of two public dialogues was held by the United Nations Secretary General’s High-Level Panel on Access to Medicines, drawing another packed room and many ideas, experiences and suggestions for solutions.
The Ukrainian Parliament is currently drafting an amended Customs Code to introduce a number of changes to the country’s intellectual property legislation. Moreover, in mid-March, local lawmakers authorised Ukraine’s President Petro Poroshenko to ratify the protocol amending the TRIPS agreement which enables increased exports of pharmaceuticals produced under compulsory licences to countries which are not capable of manufacturing them locally.
Despite impressive growth, the pharmaceutical sector in China still relies on generic drug production since the majority of domestic companies cannot compete with country-based foreign corporations. Currently, following WTO pressure to oblige China to comply with IP regulations, more and more patented drugs are entering the market. Unfortunately, in spite of a newly introduced IP friendly bill, a puzzling situation persists, writes Pietro Dionisio.
Two key senators today released dozens of comments they received in response to their report on the medicine Sovaldi (and its follow-on Harvoni), whose extreme high prices sparked a debate over pharmaceutical pricing that has created momentum for policy changes.