#EAPM - Legal threat to parallel trade in medicines watered down by EU

Countries in the European Union have been given the green light to restrict parallel trade on pharmaceuticals if they have shortages in their own member state,

The European Commission last week released a paper from an advisory group saying that certain restrictions might be justifiable “based on transparent, publicly available and non-discriminatory criteria that are known in advance by economic operators.”

This should ensure that they “are not placed arbitrarily”, the paper says.

In the recent past, some EU member states (mainly in central and eastern parts of the bloc) have blocked the export of some medicines because they share this has led, or could lead to, shortages in their own country.

But that has caused problems, not least in a legal sense, because parallel trade is not illegal in the EU and moreover ties in with the principal of free movement of goods.

Poland, Slovakia and Romania were three countries under the legal spotlight but, just a month-or-so ago, the EU Executive decided not to pursue them on a legal basis.

Meanwhile, the Czech Republic, Estonia, Greece, Spain, Finland, France, Hungary and Portugal also have restrictions in place and will now feel that they need no longer need to fear falling foul of EU sanctions, although the Commission paper says that authorities should consider whether or not there are alternative treatments available.

Also, any restrictions with also be open to appeal.

Several member states have complained that the parallel pharmaceuticals trade bring about shortages and suffering for patients back at home.

The Commission has said that: “The lack of appropriate and continued supplies of human medicinal products to pharmacies is a serious and growing problem that has occurred in recent years in a number of Member States and can gravely impact the treatment of patients.”

The paper’s content is not actually legally binding, as the Commission notes, because the European Court of Justice remains the only arena that can give an “authoritative interpretation of Union law.”

The paper reminds member states that Article 81 includes: “The holder of a marketing authorization for a medicinal product and distributors of the said medicinal product actually placed on the market in a member state shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorized to supply medicinal products so that the needs of patients in the member state in question are covered.”

Yet the Commission also emphasizes the need for “compliance with the Treaty rules, particularly those concerning the free movement of goods and competition”.

It adds that marketing authorization holders should notify any interruption of supply of medicinal products in good time, by which they specify at least two months in advance.

It goes on to say that the notification should include data on sales volumes and the volume of prescriptions and, if doable, indicate possible alternative medicinal products.

“It should also include information on the estimated duration of the supply interruption as well as any corrective action taken to remedy the situation,” the paper says.

Wholesale distributors should, the Commission says, ensure continuous supply to pharmacists and the person entitled to supply to the public to cover the needs of the patients on the territory where the distributor is established.

But marketing authorization holders have a series of get-out clauses absolving them of responsibilities for shortages in certain circumstances.

These include, according to the paper: “Shortages caused by the export/supply by a distributor of medicinal products to another customer in a different member state for which they are not aware (as long as they have not failed to meet ordinary orders in relation to the size of the market of the member state concerned), and; shortages caused by increased demand from a shortage in the member state of an alternative medicinal product produced by another company

On top of this, the Commission accepts that wholesale distributors “may not be responsible if marketing authorisation holders fail to enable supply of sufficient stocks of medicinal products to cover the needs of pharmacies or persons entitled to supply to the public in a member state”.

The Executive has also said in a statement: “Reconciling the respect to the free movement of goods with the right of access to health care to patients is a fine balancing act,” adding that it is looking at alternatives “to adequately solve this complex situation in order to swiftly and efficiently deal with an issue that might have a negative impact on the health of European citizens”.

It remains to be seen what the checks-and-balances will be regarding parallel trading of pharmaceuticals but the door appears to have been opened, and legal threats removed, albeit within what the Commission deems to be justifiable circumstances.