News - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

News


Pharmaceutical Technology Europe


Medicines at Top of EU's Counterfeit List


Nicholas Rigg/Getty Images
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.

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.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
33%
Breakthrough designations
11%
Protecting the supply chain
39%
Expedited reviews of drug submissions
11%
More stakeholder involvement
6%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology Europe,
Click here