Parliamentary report broadens, accelerates counterfeiting directive

The European Parliamentary report on the proposed counterfeit directive is now in circulation, with the author, MEP Marisa Matias, putting forward a number of amendments that widen its scope.

The headline amendments include the inclusion of Internet sales, bringing medicine brokers into the remit of the Directive, boosting criminal sanctions to bring medicines counterfeiting into line with trading in narcotics, and including not only medicines and active ingredients but also excipients.

Matias is the rapporteur for the Parliament's Environment, Public Health and Food Safety (ENVI) committee, which has been given the task of reviewing the draft Directive put forward by the European Commission in December 2008.

The EC's draft focused on implementing new obligations for non-wholesaler medicine distributors, obligatory audits of wholesalers, the addition of safety features such as serialisation codes and seals to packs to medicine packs, and strengthened controls on imported active pharmaceutical ingredients (APIs).

Matias has also halved the deadlines for implementation of the Directive by member states to 12-24 months after adoption by the EU, indicating in her comments that falsified medicinal products are "a concern which is getting higher and higher on the agenda of the European citizens."

Ahead of the official announcement of the report, SecuringPharma.com has summarised some of the key amendments.

Definitions

A key aspect of the document is the drawing up of definitions for a falsified medicinal product, active pharmaceutical ingredient (API) and excipient, as well as the various actors in the supply chain.

The rapporteur maintains that the EC draft does not provide enough clarity, and notes her amendments  are designed to prevent confusion and remove any room for 'grey' areas. "Clear definitions will result in simpler implementation," she notes.

Safety features

One sticking point for the EC draft was a statement indicating that parallel traders which repackage medicines should apply security features that are 'equivalent' to those placed on the original pack by the marketing authorisation holder.

Matias has fleshed out this proposal noting that repackagers must apply features that "offer the same level of efficiency for ascertaining identification, authentication, traceability and absence of tampering, as well as the same level of technical difficulty for duplication."

The requirement to add safety features has also been extended to certain generic medicines on the basis of a risk-assessment, and Matias is calling for a five-year assessment report to review the success of the measure and gauge whether over-the-counter medicines should also be included.

Excipients

The EC's draft Directive made no specific mention of excipients, and Matias has addressed this with several mentions throughout the amended version.

"The consequences of the use of falsified excipients are well documented," notes the report, alluding to recent cases in Haiti and India.

The new version includes a statement that "excipients shall be subject to the same conditions of good manufacturing and distribution practice" as active ingredients.

Last year, the European Commission drew back from earlier plans to develop a specific Directive on GMP for certain high-risk excipients, so industry is currently relying on voluntary standards such as the GMP guides developed by the International Pharmaceutical Excipients Council (IPEC).

Internet sales

The EC draft was widely criticised for not attempting to tackle the Internet trade in counterfeit pharmaceuticals, which remains the most likely point of entry for fake medicines in Europe.

In the new report, the rapporteur says that "member States shall ensure that the Internet is continuously monitored by a designated body with regard to the selling of medicinal products and shall take legal actions in the event of non-compliance with this Directive."

"A directive aiming at fighting the falsification of medicines, without dealing with internet, the most important route, is not explainable to the public," notes Matias.

Inspections

The new version places a greater emphasis on inspections, including unannounced inspections of API and excipient manufacturers based in third countries, and sets out the objective of inspecting "every single API manufacturer situated outside the Community" and "effectively combating API falsification."

This can be achieved, says the report, by pooling together the resources of the 27 EU member states as well as from the USA, Canada and Switzerland under the coordination of the European Medicines Agency (EMA). A marketing authorisation holder affected by a falsified API will risk the loss of its license to sell the medicine until the matter is resolved.

Middlemen

The amendments place more emphasis on traders and brokers of medicines "because these represent a real weakness as they are not yet associated with accountability and liability." It also gives a definition of brokering to differentiate it from trading.

Brokers must now check whether medicinal products they have purchased are not falsified by authenticating the safety feature on the outer packaging, and will be accountable and held responsible in cases of counterfeit.

Intellectual property

The EU has come under criticism of late for conflating the issue of counterfeiting with infringement of intellectual property, prompting allegations that the counterfeiting drive is part of an attempt to stifle generic competition of the branded medicines industry.

Matias has added a number of clauses to the draft Directive that explicitly decouple counterfeiting from IP rights, noting that "this directive should focus on the consequences for public health and should not deal with possible problems related to intellectual property rights or patent rights."

 Other proposals include training of customs officers to identify falsified medicines, which could help avoid seizures of legitimate generic medicines in transit to other markets at EU borders. The rapporteur also wants to develop concerted actions with the competent authorities of third countries to inspect transit zones for medicines.

Exports to third countries

It is recognised that counterfeit products have been brought into the EU on an 'import for export' basis, and the report is trying to put up a barrier to this practice by increasing the responsibility and record-keeping requirements for wholesalers.

"It is difficult to explain why we have stringent provisions for medicines that enter the European market in order to find the responsible actors if medicines are falsified, but no provisions for medicines which are exported to third countries in Africa, South America or Asia," notes Matias.

Criminal penalties

Finally, the report points out that the falsification of medicinal products is not a minor offence but "an organised criminal activity that puts human lives at risk."

Sanctions against falsification should reflect this, it says, and should be equivalent to those typically applied for illegal acts related to narcotics.

The amendments now go forward for a full plenary debate in the European Parliament in the spring.

Additional articles on the individual aspects of ENVI committee's amendments will be published on SecuringPharma.com after the official circulation of the report.


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