Medicines at Top of EU's Counterfeit List
A report from the European Commission shows that fake pharmaceuticals were the top articles detained by European-Union customs
in 2011. Customs seized almost 115 million products suspected of being counterfeit, up from 103 million in 2010. Approximately
24% (around 27 million) of these products were medicines, compared with just over 3 million in 2010.
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In 2011, there was an increase in the number of counterfeit items that could be potentially dangerous to health and safety
(i.e., food and beverages, body care articles, medicines, electrical household goods and toys). Such products accounted for
28.6% of seizures, compared with just 14.5% in 2010. The EC report attributes the increase to the large rise in medicines.
In general, the increase in the number of detained articles has been attributed to rises in postal traffic, of which medicines
formed a large percentage. Approximately 36% of detained items in postal traffic were medicines.
According to the report, China is the main source of the counterfeit products, accounting for 73% of all intellectual-property
infringing items. The majority of the counterfeit medicines detained by EU customs in 2011 originated from China (68%) and
India (28%). In 2010, almost all of the medicinal products identified by customs came from India (93%). In 2011, most articles
were intercepted in Bulgaria, Italy, Greece, Belgium, and the Netherlands, compared with Greece, Italy, Spain, the Netherlands,
and Portugal in 2010.
MHRA Consults on Early Access to Medicines
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation regarding a scheme
that could provide patients with access to unlicensed medicines in Phase II or III clinical trials. The consultation will
be open until 5 October.
The scheme is expected to apply to medicines for life-threatening, debilitating, or chronic conditions that are at the end
of Phase III trials or, in certain cases, at the end of Phase II. Research conducted by MHRA has shown broad support for such
a scheme, particularly for patients suffering from life-threatening illnesses.
If implemented, MHRA would review medicines that companies want to make available under the scheme and provide a scientific
opinion on the risks and benefits. This information would help the country's National Health Service in deciding whether the
medicine should be available early.
"We have launched this consultation because we are committed to ensuring that where pharmaceutical companies want to make
their new medicines available under this scheme, clinicians treating patients have access to robust scientific information
to help them make appropriate treatment decisions," explained Kent Woods, chief executive of MHRA, in a statement.
In its research, MHRA emphasises that patients will need to be fully aware of the risks of taking unlicensed medicines. There
were also mixed views on whether early access to medicines should be given to patients with debilitating or chronic conditions,
such as rheumatoid arthritis or diseases that may cause blindness.
After receiving industry feedback, MHRA will aim to make a decision on implementing the scheme by the end of 2012.