The Falsified Medicines Directive (FMD), which was formally adopted in the European Union in 2011 and came into force in January last year, is designed to stop fake and substandard drugs and ingredients entering the Euorpean supply chain.
It is too early to say how effective the FMD has been at preventing counterfeit drugs and APIs from reaching Europe according to the European Medicines Agency (EMA).
The organisation told in-Pharmatechnologist.com that: "The directive foresees that the Commission shall submit a report to the European Parliament and to the Council containing an evaluation of the contribution of the measures provided for in the Directive regarding the prevention of the entry of falsified medicinal products in the legal supply chain. But it might be a little early to have data on this, as it is mentioned such a report should be submitted five years at the latest after implementation."
This was echoed by the European Commission who told us that: "The Commission, EMA and Member State authorities have been monitoring its implementation continuously and, it goes without saying, are in close contact with industry on this. Third country API manufacturers continue to be inspected by Member State competent authorities. All non-compliances are followed up. Non-compliance results in the suspension of acceptance of the written confirmation.
The organisation added that: "It is up to manufacturers to make decisions concerning their supply chain and investments, as long as these decisions comply with the EU legal framework."
Over reliance
But, even if the FMD is a success, there is still a problem with where the European drug industry sources its products according to new EFCG President Heinz Sieger.
He told in-Pharmatechnologist.com that: “Even after the introduction of the new Falsified Medicines Directive (FMD) in July 2013, we are still concerned about the continuing and, in our opinion, alarming dependence on lower cost APIs and formulated drugs from non-EU countries.”
Dr Sieger, who is chairman of the board of CU Chemie Uetikon GmbH, also suggested that new laws - which were designed in part to encourage authorities in supply countires to play a greater role in overseeing the quality of drugs and ingredients shipped to Europe - have themselves created new challenges for regulators.
“The European Authorities need to check that API and drug product importers are FMD-compliant to ensure that the supply chain is secure and that EU drug producers’ dependence on imports is optimised with a back-up manufacturing position using the high quality and the experience of the European Fine chemicals Industry.”
The comments are in keeping with previous statements by the EFCG. In November 2012 the organisation told us the law’s advocacy of manufacturing site audits rather than inspections meant that it was not enough to ensure qulaity.
And last year the EFCG suggested underlying drugmaker concerns about the quality APIs made outside the EU had prompted a round of active pharmaceutical ingredient (API) stockpiling that had driven an increase in business for member organisations.
Contract chemical opportunities
Sieger was made President of EFCG - which is a sector group of the European Chemical Industry Council (Cefic) - last week in the first in a series of executive appointments.
Zach System’s CEO, Roger LaForce, was named as vice president and Hubert Stueckler, until recently President of the Actives Division and Head of Global Operations of Siegfried, was appointed sector group manager.
in-Pharmatechnologist.com took the chance to ask the new President what he and his colleagues think are going to be the biggest growth opportunities the pharmaceutical industry will offer Europe’s fine chemicals sector going forward.
“We see quite good growth opportunities in the contract manufacture of more APIs in the pipeline of the Innovator Drug Industry as we can offer a high quality service from development to market.”
Sieger also suggested that patent loss and the continuing growth of the biopharmaceutical sector would present opportunities.
“As many more NCEs come off patent there is also good contract manufacture potential for Fine Chemical firms in the Generic Drug Industry. Also new projects from the Bio Pharma Industry could contribute to the growth of our industry.”