By Anna Petherick

Chile’s growing trade with the US, Europe and China in recent years has made the Andean nation one of the most economically stable and prosperous countries in South America. Yet, despite Chile’s economic success, the country has continued to fall short on intellectual property laws. This lax enforcement of patent rights, experts say, has dissuaded many international companies, including the pharmaceutical sector, from investing in the country.

To bolster Chile’s patent protections and create a friendlier business environment for pharma, the country’s ministry of health last month announced plans to introduce legislation that would establish a new national medicines agency, called the Agencia Nacional de Medicamentos. The regulatory body, to be modeled after the US Food and Drug Administration, would replace the existing agency, the Instituto de Salud Pública de Chile, which has been criticized for showing favoritism to local firms and for turning a blind eye to sloppy manufacturing standards. In 2009, for example, just nine out of 34 drugmakers in Chile were certified as having good manufacturing practices.

The new agency, known as ANAMED, is intended to sort this out. First among its tasks will be to ensure that generic drugs meet bioequivalency standards—that is, that their rates and extents of action are statistically similar to the medicines that they imitate. At present, Chile enforces such requirements for only a small number of drugs, such as antibiotics, leaving the bulk of the industry to demonstrate bioequivalency on a voluntary basis. According to Ruben Gennero, a Latin American healthcare and pharmaceutical analyst with IHS Global Insight, only eight medicines currently comply with bioequivalency standards; by the end of January 2012, however, ANAMED intends to enforce these requirements for more than 300 medicines.

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By Karen Dente

A controversial set of rules in the EU that changes the way herbal medicinal products are licensed and marketed in Europe came into full force this May, ending a seven-year grace period that had allowed manufacturers to come up to speed on the new measures.

Under the law, any plant product with a new curative claim sold over the counter is subject to an approval process the same as the one that pharmaceutical drugs are required to undergo when seeking marketing authorization. Additionally the new regulations, known as the Traditional Herbal Medicinal Products Directive, will force natural products producers to adhere to the standards of good manufacturing practice, a set of guidelines designed to ensure the quality of a product.

Although the use of herbal medicines in Europe is on the rise, the safety regulations governing these products in the EU have been “a mess,” according to Frederic Vincent, spokesperson for the EU Directorate General for Health and Consumers in Brussels.

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Image: Tracy Hunter, Flickr under Creative Commons

By Tony T K Lam

Countless biomedical discoveries have been made possible thanks to the hard work of graduate students. But students in China lack the same breadth of externally funded scholarship programs as their counterparts have in the West. If the Chinese government wants to strengthen its recruitment of elite graduate students from around the globe, it should expand the scholarship programs it offers.

China’s rapidly growing wealth continues to grab headlines, with the country’s yearly economic growth hovering in the double digits for much of the last decade. Buoyed by its economic expansion, two years ago China announced a special effort, known as the ‘one-thousand-talents scheme’, offering a bonus of 1 million renminbi ($150,000) per person to attract scientists who hold professorships in other countries (Nature 457, 522, 2009). There is a clear drive to entice top-tier faculty: just a year ago, BGI, a genomics institute based in Shenzhen, China, ordered 128 massive, high-tech DNA sequencers, creating an impressive infrastructure that any researcher in the world would want access to.

The push for elite research comes at a time when the country faces a real need for new medical solutions: almost half of the 200 million people in the world with type 2 diabetes live in China (N. Engl. J. Med. 362, 1090–1101, 2010). Many laboratories worldwide, including mine in Toronto, have research programs that aim to combat this epidemic. These research operations are made possible largely through externally funded granting agencies such as the Canadian Institutes of Health Research (CIHR). Because operating grants typically fund the daily salary of research trainees and staff in North America, the working capacity of a laboratory is greatly enhanced if the salaries of graduate students can instead be externally funded by a scholarship.

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