Fake Drug Conviction and Movement toward a Pan-European Law
The Medicines and Healthcare products Regulatory Agency (MHRA) is reporting that a trial regarding the import of more than two million doses of fake drugs into the United Kingdom has ended in a conviction. According to MHRA, Peter Gillespie of Windsor, Berkshire, was found guilty of all charges and sentenced to eight years in prison. Called Operation Singapore, the case "involved the infiltration of counterfeit medicine into the UK legitimate supply chain during a five-month period in 2007," MHRA reports on its Web site. Of the more than two million doses, MHRA did seize a significant portion, but nearly 900,000 reached pharmacies and patients, MHRA reports. STORY CONTINUES BELOW
Gillespie's conviction follows the European Parliament's adoption of the "Falsified Medicines Directive" in February. The legislation is intended to protect EU citizens from falsified medicines, which are defined as products that "may contain ingredients in the wrong dosage or no active ingredients at all." (Interestingly, a distinction is made between "falsified medicines" and "counterfeit medicines," which are defined as "medicines that do not comply with EU law on intellectual and industrial property rights, such as registered trademarks or patent rights." According to a memo issued February 16, the Directive on falsified medicines does not deal with "counterfeit" drugs.) European Commissioner of Health and Consumer Policy, John Dalli, stated in February: "Falsified medicines are a serious public health risk in the EU. They have not been subject to an authorisation procedure where aspects of quality, safety, and efficacy of the medicine are verified. The law passed today introduces harmonized, pan-European safety measures that provide the highest possible level of assurance that only high-quality medicines are sold within the legal supply chain in the EU. It also addresses sales of falsified medicines over the internet by providing for an obligatory trust mark on websites of legally operating online pharmacies. I look forward to a swift implementation of this Directive by the Member States." MHRA welcomes the support. The agency drafted is own "Anti-Counterfeiting Strategy" for 2007 to 2010, encouraging collaboration with drug manufacturers and others. "Taken together, the UK and EU proposals will significantly strengthen the supply chain in the UK," MHRA states on its site. According to the European Commission (EC), new measures include:
The EC defines the "authenticity feature" as "a unique identifier on the outer packaging which allows verification of the authenticity of the medicinal product. Up to now, the regulation of authenticity features on medicines was conducted at Member State level. This Directive addresses this aspect at EU level. It provides a legal basis for establishing details for these safety features and the level of their control in the distribution chain." EFPIA, an organization representing the pharmaceutical industry in Europe, describes the unique identifier as "a pan-European system to provide unique serial numbers (such as two-dimensional bar codes) on each genuine medicine pack. . . . to ensure maximum effectiveness it is vital that all medicines are verified systematically at pharmacy level." According to EFPIA, "the next step will be for the Council to formally approve the final text before it can come into force." The Directive must be transposed by the Member States into national law within 18 months. Some measures, such as those related to the safety feature, have a longer implementation time, the EC reports. There have been "15 known instances of counterfeit medicines in the UK regulated supply chain since 2004," MHRA reports. In addition, counterfeit condoms, dental materials, glucose test strips, and contact lenses have been found. Overall risk is minimal, however, when viewed in the context of the 850 million prescriptions dispensed annually in the UK, the agency claims. Nonetheless, MHRA Head of Enforcement Mick Deats said in an MHRA statement: "We share the concerns of patients across the UK. All patients have a right to expect that medicines supplied to them are genuine and meet appropriate standards of quality safety and efficacy." Gillespie's conviction "sends a clear message to those involved, or contemplating involvement in, the manufacture and supply of counterfeit medicines. Public health is a matter of public concern and those deliberately putting people's lives in jeopardy should expect to be vigorously pursued through the criminal courts," Deats said. For more details, visit |
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