Proposed Latvia drug legislation raises concerns

Concerns have been voiced about a proposed change in national legislation for drug approval in Latvia that will strongly favour so-called parallel importers.

The Brussels based watch-dog International Foundation for Better Governance has called for the plans to be reviewed or scrapped altogether by Latvia, which is the current holder of the rotating EU presidency.

The Foundation 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.

Opponents of the proposed regulatory changes hope to raise the issue at the Eastern Neighbourhood Partnership summit the EU has convened in Riga on 20 May.

Parallel imports are imports of a patented or trademarked product from a country where it is already marketed.

Sometimes referred to as “grey market” imports, parallel imports often takes place when there is differential pricing of the same product - either brand-name or generic drugs - in different markets.

Critics claim that the quality supervision system for imported drugs in Latvia would be "destroyed" if the draft amendments are adopted.

They say that the regulatory changes would allow all drugs to be imported from third countries but that this risks contravening the EU directive on falsified medicines.

This directive has the effect of forcing third country producers of pharmaceuticals (from which a parallel importer would import drugs) to adhere to the best practices of European producers.

However the proposed Latvian regulatory amendments do not comply with the provisions of the Directive.

There is also a risk that imported drugs from third countries would be “re-packaged” in order to avoid the checks and balances registered importers face, raising the spectre that counterfeit pharmaceuticals may enter the supply chain in other member states with seriously damaging consequences for consumer health in Europe.

The main legal problem with the draft amendments is that they 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 respected Brussels-based NGO claim thats the proposed regulatory changes in Latvia do not comply with the principles of the European Union’s Good Manufacturing Practice and Good Distribution Practice.

"In short," a spokesman for the Foundation said, ”the draft Latvian rules on reimbursement of parallel imported medicines exempt these products from many of the restrictions and rules that apply to standard medicines.