Latvian legislation changes 'may exacerbate counterfeit medicines problem'

A major pharmaceutical association has expressed reservations that legislative changes in Latvia may add to the problem of counterfeit medicines flooding into Europe.  Anda Blumberga, of SIFFA, the Latvian Association of Innovative Manufacturers, says the law change will also put manufacturers of pharmaceutical products  in and “unfavourable position” compared with “parallel importers”. 

Parallel imports are imports of a patented or trademarked product from a country where it is already marketed.  His comments echo previously voiced concerns that a change in national legislation for drug approval in Latvia will strongly favour so-called parallel importers.  The intervention by Blumberga comes on the eve of a visit on Monday to Riga, the Latvian capital, by EU health and food safety commissioner Vytenis Andriukaitis.  Commissioner Andriukaitis will attend a Latvian Presidency health care conference, being organised by the European Federation of Pharmaceutical Industries and Associations (EFPIA), together with the European Patients' Forum (EPF), the European Generic and Biosimilars medicines Association (EGA) and the European Public Health Alliance (EPHA).  SIFFA, also a member of EFPIA, promotes the operations ofpharmaceutical companies in Latvia. SIFFA also represents drugs giants like Pfizer, Novartis and GSK.

The commissioners' visit comes amidst a growing storm about the new law with one amendment already adopted at a controversial Latvian Cabinet meeting last month with other proposed amendments submitted to the Cabinet for adoption.  Riga is now coming under increasingly pressure to revise or scrap the controversial amendments which it is said 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.  There are fears that changes in the system for drug registration will “open the floodgates” to counterfeit drugs in Europe because “parallel importers” will not be subject to the same checks and balances as provided for in the current legislation existing registered importers in Latvia.  The proposed law change tabled by the Latvian health ministry will put consumer health and safety at risk, it is alleged.

Blumberga, who is a board member of SIFFA and also Country Manager (Latvia) of Sanofi, the global healthcare leader, told this website: “We have had new reimbursement system regulations in force in Latvia from June 1 which are placing manufacturers in unfavourable position versus parallel importers. Parallel importers can update the product prices monthly while manufacturers can update their prices only quarterly. It can lead to unpredictable supply forecasts for manufacturers, possible interruptions of medicine supply for patients.”  He added: "We cannot foresee how large volumes of the same product will be imported by PI companies from other countries.”

Blumberga, who said he was expressing his concerns as a SIFFA board member, said that other regulation changes about packaging and distribution will also favour parallel trade products  because this involves “simpler package requirements and such items can be imported directly to pharmacies.  The draft regulation, he says, will also make it possible to repackage products in pharmacies from larger packages to smaller one.  Crucially, Blumberga added: “These changes may lead to a falsified product appearance in the supply chain.”

There are fears that the Latvian legislative change contravenes several EU directives, including the directive on falsified medicines, adopted in 2011 which aims to make the legal supply chain for medicines fully secure.  It refers specifically to the issue of counterfeit medicines and Sanofi was actively involved in the work groups that led to the adoption of the directive.

Blumberga points out that SIFFA has expressed its reservations  to the Latvian health ministry during discussions about the ongoing changes.  Concern has also been raised by the Latvian Association of Generic Manufacturers while the Brussels based watch-dog, the International Foundation for Better Governance (IFBG) has called for the plans to be reviewed or scrapped altogether by Latvia, which is the current holder of the rotating EU presidency. An IFBG spokesman said: “There are inherent dangers in opening the floodgates for an uncontrolled circulation of illegal and counterfeit drugs to the detriment of European consumer health. This also comes at a particularly bad time when the EU is actually celebrating 50 years of security and safety for consumers thanks to EU pharmaceutical legislation.

“The question is: Why does the European Commission not call for Latvia to notify the package of amendments and suspend implementation in order to allow time to check that there is full compliance with EU directives?"

French MEP Jean-Luc Schaffhauser has also submitted a formal parliament question (PQ) to the European Commission adding their concerns to the changes.  He said: “All the countries of EU and in the world have to fight against counterfeited goods. It is a question of fair trade, particularly in the common market of the EU.

“This question is more important in the case of drugs and medicine. The Latvian decision opens the doors of the EU, and of all our countries to a massive smuggling of counterfeited medicines. This is a significant risk for the health of Latvia, of France, of Britain and others.”

Enrico Brivio, spokesperson for health, food safety, environment, maritime affairs and fisheries, said the Commission was unable to comment at this stage.  However, further comment comes from Caroline Atlani director, anti-counterfeiting co-ordination at Sanofi, who said: “Counterfeit medicines are a real danger to patient health. They don’t contain the expected amount of active ingredient and they don’t meet any of the standard requirements for quality, efficiency and safety. So patients run a number of risks: besides the presence of toxic substances, these drugs can be inactive and cause major adverse effects and complications for patients.

“Fake drugs can also undermine patients’ confidence in the health system by virtue of the infringement of their legitimate right to be treated with quality medication. So there is a major ethical concern here.”

More than 4,000 products were analyzed in 2013 with more than 200 confirmed cases of counterfeit products. While the number of analyzed medicines remains stable, the nature of the products analyzed is expanding considerably.

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