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EFPIA to monitor draft medicine legislative changes in Latvia

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Counterfeit-drugs-010The EU-wide trade body overseeing Europe's pharmaceutical industry says it will “monitor” draft legislative changes in Latvia that some fear could lead to a surge in counterfeit medicines (pictured) entering the supply chain. 

The European Federation of Pharmaceutical Industries and Associations (EFPIA) says it hopes that a change in national legislation for drug approval in Latvia will not “jeopardize patient safety”.

The intervention by EFPIA, the body that represents the pharmaceutical industry operating in Europe, comes amid growing concern that a law change in Latvia will strongly favour so-called parallel importers and could “open the floodgates” to fake medicines.

The latest twist in the long-running saga came last week when the Latvia national drug agency suspended the operating licence of a Latvia drug wholesaler alleged to have been caught up in a fake drugs transit scheme.  It is alleged that the company knowingly or unwittingly purchased drugs from an unlicensed company, believed to be Russian based, although there is no suggestion that it sought to falsify drugs.

The move comes in the wake of a recent report by Italian investigators who found there was a “Latvian connection” to an EU-wide network involving counterfeit or stolen pharmaceuticals.  The latest developments this week give further credence to those who say that under the proposals tabled by the Latvianhealth ministry,“parallel importers” will not be subject to the same checks and balances as provided for in the current legislation existing registered importers in Latvia. This, it is claimed, could put consumer health and safety at risk.  The changes are said to will provide a “very favourable regime” for parallel imported products that is not in line with the rules that apply to the standard products sold on the Latvian market.

The concerns have re-emerged following a major health conference EFPIA hosted in Riga, the Latvian capital (29 to 30 June). EU health and food safety commissioner Vytenis Andriukaitis was among the speakers.  The conference was held under the auspices of the outgoing Latvian Presidency of the Council of the European Union.

EFPIA Director General Richard Bergström told this website: “EFPIA is aware that patients in smaller European markets not always get the medicines they need. One reason could be that the medicine is not approved locally or made available due to high administrative costs for companies, or that the volumes are small.

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“These are legitimate reasons for companies to act in a certain way, but must not hurt patients. EFPIA will monitor the new provisions in Latvia and will raise concerns only if the new scheme is misused or if it jeopardises patient safety by enabling counterfeit medicines to enter the supply chain.”  EFPIA says that, according to the draft regulation, pharmacies will be allowed to purchase unauthorised medicinal products from the entity (wholesaler, pharmacy) authorised in another member state or in the third country and entitled to the distribution of medicinal products, and distribute these medicinal products in Latvia (import and distribution of unauthorised medicinal products).  It says that such a provision only applies to “very exceptional” circumstances and is limited to “named patient sales and compassionate use programmes.”

These are recognized EU law exceptions to the marketing authorisation requirement. The Court of Justice has, however, held, that named patient sales must remain exceptional.  “If the conditions under the new rules clearly threaten the exceptional nature, this could be an argument for illegality and indeed a potential floodgate for counterfeit medicines from third country markets,” says EFPIA, which brings together 33 European national pharmaceutical industry associations and 40 leading pharama companies.  It adds: “There are concerns about the entry of counterfeit medicines in the EU either via internet sales or directly into the legitimate supply chain.”

EFPIA points out that the discovery of counterfeited generic Omeprazole in the German supply chain in March 2014, was the trigger for the Commission and member states to take a “very restrictive” approach with respect to potential exemptions for prescription-only medicines from the scope of the “Falsified Medicines Directive.”  There are fears that the Latvian legislative change contravenes several EU directives, including the Falsified Medicines Directive, adopted in 2011 which aims to make the legal supply chain for medicines fully secure.

EFPIA says that EU legislation “requires that prescription-only medicines will have to bear safety features, that is, a unique identifier or serial number placed on each pack together with tamper evident packaging.”  Others to express concerns about the Latvian proposals include the Association of International Research-based Pharmaceutical Manufacturers (SIFFA), which represents pharma giants such as Pfizer, Novartis and GSK and the Latvian Association of Generic Manufacturers.

Elsewhere, the Brussels based watchdog, the International Foundation for Better Governance (IFBG while a formal Parliamentary Question has been submitted to the Commission about the matter.  EFPIA recently signed an agreement with the Latvian government on the “gradual development of mutual cooperation” in the health field.  The Commission was asked to comment on the controversy in Lavia and what progress the visit to Riga this week by Andriukaitis may have achieved in resolving the issue.

But Enrico Brivio, spokesperson for Health, Food Safety, Environment, Maritime Affairs and Fisheries, said the Commission was unable to comment.  Even so, Caroline Atlani director, anti-counterfeiting Coordination at Sanofi, said:  “Counterfeit medicines are a real danger to patient health and Riga is under pressure to revise or scrap the controversial amendments altogether."

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