19 April 2011 | Naouel
Industry experts have
welcomed legislation that tightens security around pharmaceutical supplies but
warned more needs to be done.
The calls from
pharmaceutical companies follow what has
been described as the most serious known breach of counterfeit medicines in the
UK regulated supply chain.
Earlier this month a
British national was sentenced to eight years in prison for his part in a crime
that saw more than two million doses of fake drugs infiltrating the UK supply
chain between January and April 2007.
Despite most of the drugs
being seized or recalled at the time, 700,000 unaccounted-for doses of Zyprexa
(used in the treatment of psychosis), Plavix (used to prevent blood clots) and
Casodex (used in the treatment of prostate cancer) reached high-street
pharmacies, hospitals and care homes across the country, penetrating the NHS
Mick Deats, head of enforcement
at the Medicines and Healthcare productsRegulatory Agency (MHRA) told
SM that this type of case is
extremely rare, and should be seen in the context of a massive national supply
chain. It has, however, influenced legislation at both European and UK levels.
The Falsified Medicines
Directive was announced this February by the European Union (EU), with measures
including the introduction of security features designed to provide evidence of
tampering, as well as tougher record-keeping requirements for wholesale
Colin Frost, head of trade
at Pfizer UK, is
hopeful that if pharmacists, generic manufacturers,
wholesalers and governments work together it “should result in
dramatically improved systems for security and consequent improvements in
He believes, however, that
some important details still need to be worked through at both European and
national levels to further secure the supply chain. “Specifics
examples of areas still to be finalised include coding and verification before
packets reach patients and which medicines should have safety features. In
summary, this is a major step, we are hopeful, but it’s not there yet.”
Fredrick Moen, director of
European government affairs at AstraZeneca, said full
cooperation of pharmacies and hospitals is vital in the fight against
now have basic legal framework in place. However, more detailed provisions are
needed and we are working closely together with other stakeholders and the
European Commission to get the system in place.
“We need to
ensure the integrity of the legal supply chain from originator to patient and
close the door for criminals.”
He added that the
initiative was not a “silver bullet” and people
needed to be aware that the majority of counterfeits are sold through illegal
Meanwhile, the MHRA has
formulated separate proposals, including the introduction of a specific offence
supplying and handling counterfeit medicines. These proposals were developed
out of the organisation’s commitment to review the supply chain as outlined in
its Anti-Counterfeiting Strategy published in November 2007.
In 2006, the MHRA had
rejected calls from pharmaceutical firm Pfizer to increase supply chain
security and ban the repacking of drugs by third parties.