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European Pharmaceutical Contractor
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The problem of disease in the developing world is a compelling and often startling realisation. In recent years, the spread of HIV/AIDS has gained the attention of the world's media and decision-makers, but conditions like malaria, tuberculosis and diarrhoeal diseases are also causing havoc among the poorest nations. With modern medicine having advanced to a higher level than ever before, the questions of how and why so many people are becoming ill have, quite understandably, become frequently asked. Indeed, these questions have brought a heightened international awareness of the difficulties being faced by some of the world's very poor, which has, in turn, prompted questions about what is to be done and, perhaps less helpfully, questions of who is to blame.
It has been claimed that the patent system has prevented developing nations from being able to afford medicines necessary for the treatment of HIV/AIDS. This was a claim made during the Doha negotiations of the World Trade Organization (WTO) in 2001. A resulting deal was struck which allowed poor countries experiencing national health emergencies to be exempt from patents for medicines that could help the crisis. Under this agreement, 'compulsory licensing', as it is called, was to be restricted to the poorest countries. The new deal was hailed by many as a way of ensuring that poorer countries would have access to medicines that had previously been too expensive. In other words, these countries would be legally entitled to manufacture generic versions of patented medicines that would help treat their national health emergency.
This year WTO negotiations took the agreement further. The most recent deal means that poorer countries, in times of national health crises, are entitled to import cheap copies of medicines that are still covered by a patent if they are unable to manufacture the medicines themselves. Before this extension of the agreement, a country would only be allowed to manufacture generic copies for domestic use. This meant that there was no allowance for countries that did not have the facilities to manufacture the medicines to have access to cheaper versions.
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By Dr Trevor Jones, Director General at the Association of the British Pharmaceutical Industry (ABPI)
Professor Trevor Jones is Director General of The Association of the British Pharmaceutical Industry, directing all activities relating to the UK pharmaceutical industry, including government relations, on behalf of 80 national and international pharmaceutical companies. From 1987 to 1994, Professor Jones was a Main Board Director of Wellcome plc, the UK-based pharmaceuticals company, where he was responsible for R&D, including the development of Zovirax, AZT, Malarone, Lamictal and Tracrium. He was awarded the CBE in the 2003 New Year's Honours List.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
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News and Press Releases |
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Azopharma Announces Plans to Implement XcelodoseTM Technology in the Production of Early Stage Clinical Trial Materials
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today plans to implement Xcelodose technology at its formulations development facility, ApiCross Drug Delivery Technologies. Xcelodose technology is a powder micro-dosing system developed by Meridica. This technology offers a unique powder dispensing system for small-scale capsule filling and ultimately assists in conserving valuable research material as well as reducing various Preformulation activities.
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