Sarah Houlton, PhD, is Pharmaceutical Executive’s international correspondent.
The debate about direct-to-consumer (DTC) advertising of prescription medicines and internet information about therapeutic products is heating up again. Non-product-specific disease awareness campaigns are now allowed. In fact, Europeans were recently treated to retired Brazilian soccer star Pel¨sponsored by Pfizer) urging the afflicted to seek help for erectile dysfunction during World Cup commercial breaks .
The United Kingdom's much-maligned National Institute for Clinical Excellence (NICE) could be in line for a shake-up if the recommendations of a House of Commons select committee go through.
In response to concerns about the low level of patient participation in clinical trials, the British Medical Association has launched an internet resource aimed at encouraging more patients to take part. Aimed at healthcare professionals, the site explains how different types of trials are conducted and spells out their ethical and best practices requirements.
With the huge costs of developing a new drug from scratch and the high attrition rates as lead compounds fail during the trials process, in-licensing has become an increasingly popular method for pharma companies to boost their pipelines without all of the outlay involved in de novo research.
The decoding of the human genome and its potential to open the door to cures for AIDS, cancer, and many other conditions that today are incurable are likely to shapethe healthcare industry for decades to come.
International trade rules play a large role in creating world poverty, according to Oxfam, an international confederation of organizations committed to end poverty. In a recent report, "Rigged Rules and Double Standards," the group accuses rich nations of robbing poor nations of $100 billion a year by abusing trade rules. It also criticizes pharma for enforcing its patents in poor countries.
The past few years have seen a steady increase in new medicines being discovered and developed in the United States and a decrease in those from Europe, where it takes much longer for new medicines to become available to patients. In some cases, it takes medicines three or four years from their approval date to reach the market in all European Union member states. So, in March 2001, the European Commission appointed a high-level group to address those issues on a Europe-wide basis, involving all the different member states and stakeholders.
The European Medicines Evaluation Agency (EMEA) has promised to get tough with pharma companies if they fail to follow its rules for reporting product side effects. It may resort to naming and shaming those that do not comply and could even prosecute offenders.
Kiln, a Lloyds of London underwriter, has come up with a novel way for pharma companies to mitigate the risk of patent challenges: insurance. Kiln created a policy for a big pharma company covering a number of patents and trademarks the company considers essential for its future profitability.
