It isn’t customary for European Union legislation to win backing from all sides. Usually, there’s a large rump of disappointed players sniping at any agreement (and if you want to see that in Technicolor and on a bigger screen that medicines legislation can offer, just watch the fights that will break out in the coming weeks over the Franco-German bid to put slack southern economies into a strait-jacket in a bid to restore Europe’s uneven and flagging growth!).

The draft directive on falsified medicines, has, however been greeted with sighs of relief almost all round. It is now only weeks away from finalization, now that the European Parliament has agreed its position on the proposals.

European health commissioner John Dalli was first into the fray when the law won the backing of EuroMPs in mid-February.  ”I welcome today’s vote on a Directive that will increase the protection our citizens from the dangers of falsified medicines”, he carolled.

The EU estimates that the number of fake medicines seized at its outer borders has tripled between 2006 and 2009 to reach 7.5 million items.

The European Federation of Pharmaceutical Industries and Associations added its own statistic, that in 2009, more than 11 million counterfeit or illegal medicines were stopped at EU borders.

French EuroMP Françoise Grossetête upped the ante even further, noting that in only two months at the end of 2009, 34 million falsified pills were confiscated — and she rejoiced that at last rules would stop ’silent killers’ getting into the supply chain.

Marisa Matias, the Portuguese EuroMP who piloted the discussions through the parliament, claimed that “since 2005, seizures of counterfeit medicines have risen by 400% and this type of counterfeiting has been a very profitable market for organized criminal networks valued at €45 billion per year.”

Worse, while the problem used to be related mainly to ‘lifestyle’ medicines, nowadays even innovative and life-saving medicines such as cardiovascular agents are being increasingly falsified. And worse still, these products are finding their way into the legal supply chain in the EU — so fakes are no longer limited just to illegal trading channels through online sales.
So these measures will ensure easier identification of falsified medicines, and improved verifications and controls at EU borders and inside the EU.

There will be strengthened record-keeping requirements for wholesale distributors, strengthened rules on inspections, and obligations on manufacturers and distributors to report any suspicion of falsified medicines.

The European Association of Pharmaceutical Full-line Wholesalers was particularly pleased that new requirements — including inspection — will apply to brokers.

And the European Association of Euro-Pharmaceutical Companies, which represents parallel distribution in Europe, called it “a leap forward for patient safety” — as well as preening itself that the new rules amounted to a “clear recognition of the parallel distribution industry”.

Even the normally taciturn (not to say obscure) Active Pharmaceutical Ingredients Committee and the European Fine Chemicals Group got in on the act, describing the vote as “a major step forward in the fight against falsified active pharmaceutical ingredients”. It was particularly jubilant that excipients had been included in the new rules.

There are, inevitably for a measure affecting so many different sub-sectors, some secondary reservations. Some groups wanted tougher enforcement, including through mandatory inspections of ingredient producers beyond the EU — which the new law doesn’t require. Some feel the proposals are still too vague, and others fear that careless drafting risks making them too constraining. So new battles are now going to take place as the mechanisms for putting the new law into effect are fine-tuned.

But at least Europe can be reasonably sure that it isn’t going to hear fundamental objections from those most penalized by the new laws — the counterfeiters themselves. If they popped their heads up in EU lobbying, that really would give the art of imitation a new dimension!

Reflector is Pharmaceutical Executive’s EU correspondent.

The report states that FDA received 1,001 reports of serious side effects for varenicline (the generic form of Chantix). That’s significantly more adverse events than heparin, which rang up only 779 reactions (and allegedly killed a few people).

Chantix gartered a ton of headlines during that same period. In January 2008, Pfizer pumped up the warnings on the drug to include suicidal thinking and depression. It is possible that the undo attention could have increased the rate of adverse reaction reporting. ISMP said that it made a point to weed out all the minor reports or possible fakes.

Initial calls to Pfizer weren’t returned, but the company’s PR team gave a ring this morning to let me know that a statement was on its way. Here’s what Pfizer spokesperson Sally Beatty had to say:

There is nothing new about this data. In fact, the number of monthly serious adverse events for Chantix has been decreasing after a peak in January. In fact, ISMP presents no evidence that smokers taking Chantix experience more accidents and injuries than those who haven’t used Chantix to help them quit smoking.

The totality of available data, which are based on complete and current information, reveal no greater frequency of accidents and injuries reported with Chantix than with other medications.

While we welcome ongoing debate on the epidemic of tobacco addiction, we believe that framing that debate in the right context is in the best interest of public health. As part of Pfizer’s commitment to medication safety, Pfizer recently launched a Medicine Safety Education website that describes how safety is evaluated throughout the lifecycle of medications at www.Pfizer.com/medicinesafety.

I guess we’ll just have to wait and see what the next quarterly report from ISMP has to say.