The European Commission yesterday (10 December) unveiled new pharmaceutical legislation designed to improve medicinal information available to patients and combat growing proliferation of counterfeit medicines in the EU.
Commission Vice-President Günter Verheugen said the priority of the 'pharma package' was patients' health and safety, though he stressed that having a "healthy European pharmaceutical sector" was very important too.
Verheugen expressed his hope that the package would help Europe to achieve its goal of being "the chemist's of the world" and the global "standard bearer for high quality bio-tech work".
Improved information on prescription medicines or advertising in disguise?
A key aspect of the package proposes stricter rules on the availability of information about prescription-only medicines. The Commission wants to give patients access to centralised EU information on their side effects.
Moreover, to ensure clarity of information, the EU executive calls for advertising of prescription medicines to be scrapped. It also wants to introduce stricter rules regarding the content of pharmaceutical adverts, including those on the Internet, in the form of an EU code of conduct.
European consumers' organisation BEUC dismissed the guidelines as "advertising in disguise," claiming that the pharmaceutical industry would be "allowed to choose on which particular disease or specific medicine and to what extent the 'information' will be provided, and how much money to spend on it".
"Obviously this proposal was prepared by DG Enterprise with industry's interest in mind," BEUC claimed.
Stemming the tide of counterfeit medicines
A further important element of the package concerns the fight against counterfeit medicines, imports of which have risen steadily for the past three years. Some 2.5 million packages of counterfeit medicine were seized at EU borders in 2007.
To tackle the growing problem, Commissioner Verheugen said the package outlined "various steps to make sure the supply chain is secure".
The Commission is proposing to introduce three safety features to ensure the "total traceability" of all medicines bought in pharmacies or online. These are a standardised barcode (the exact application method of this has yet to be decided, according to Commissioner Verheugen), an authenticity feature guaranteeing that a medicine's contents are what they should be and a standard seal to provide protection from tampering.
However, stakeholders from the pharmaceutical industry gave the package mixed reviews, notably claiming that the EU executive failed to adequately address the problem of counterfeit drugs sold on the Internet. The Commission acknowledged that though the Internet "clearly offers possibilities for criminals," it did not wish to introduce "harmonised specific rules for internet sales of prescription medicines". This will remain a decision for member states to take themselves.
The European Generic Medicines Association (EGA) said "solutions should focus on where the problems are. The EGA therefore is concerned that the main source of counterfeiting, the Internet, is not addressed" by the package.
The Commission's proposals will now be submitted to the European Parliament and European Council, where they will be discussed and voted upon under the co-decision procedure. The measures could become law within eighteen months.
Commission Vice-President Günter Verheugen said the package would without question raise the costs of production for medicinal products, which consequently would lead to increases in purchasing costs. However, Verheugen was quick to add that these should not affect consumers, as "in virtually every case, these medicines will be paid for by health insurance systems in member states".
He claimed that "in total, there will be savings" for the European pharmaceutical industry and consumers alike, but warned that these were "difficult to calculate" at present.
Monique Goyens, director general of European consumers' organisation BEUC, issued a damning critique of the package, claiming: "The proposal on information to patients is just a disguised way of giving pharmaceutical companies greater flexibility to provide the information they want on prescription medicines directly to the public, namely direct-to-consumer communication strategies - the goal of which in our view is to boost sales."
She went on to conclude that it was imperative for the Parliament and Council to "nip this proposal in the bud".
Arthur J. Higgins, CEO of Bayer HealthCare and president of the European Federation of Pharmaceutical Industries and Associations (EFPIA), welcomed the publication of the pharma package by saying: "We recognise the benefit to EU citizens and patients of the new provisions for pharmacovigilance and improved access to health and medicines information."
On a slightly less positive note, he added: "The industry believes that the best way to protect patients would have been a ban on repackaging of medicines."
The European Association of Pharmaceutical Full-line Wholesalers (GIRP) expressed regret over the "lack of initiatives to properly tackle a number of important issues associated with the distribution chain," specifying that "despite the widespread problem regarding the number of distribution licenses throughout the member states, ranging to over a 1,000 in some countries, no attempt is made to clean up or harmonise the conditions under which member states grant new licenses or control existing ones".
The European Generic Medicines Association (EGA) said the package "appears to be well-balanced following the intense discussions conducted during its elaboration," and praised the "proposal's attempt to harmonise the current framework of industry information to patients throughout member states".
However, the EGA reasserted its concern over "possible misuse of information as a marketing tool," adding: "It is crucial to the EGA that the proposal ensures better - rather than simply more - information to patients in order to avoid any form of direct marketing and exerting undue commercial influence over consumers."