[Upd-discuss] Michelle Childs: EC rules undermine curbs on excessive pricing or other abuses involving medicines

[James Love]

http://downontheriver.blogspot.com/2006/03/eu-preparations-for- 
possible-bird-flu.html

EU Preparations for possible Bird Flu Pandemic (2)

Wednesday, March 15, 2006
Michelle Childs

We are currently in correspondence with the EU Commission to find out  
whether they can issue a compulsory license to generic drug  
manufacturers to make generic versions of oseltamivir ( brand name  
Tamiflu,) in the face of predicted shortfalls in the recommended  
stockpiles in some Member States. (Details here http:// 
downontheriver.blogspot.com/2006/03/is-europe-doing-everything-it-can- 
to.html)

The European Generic Medicines Association ( a trade body for generic  
manufacturers) have also written to the Commission asking whether  
other legal rules, granting further protection to patent owners over  
test data would be waived, in order to allow them to make the drugs  
quickly. The answer? No, not even in an emergency.

A copy of the letter is here:. http://www.cptech.org/IP/health/ 
dataexcl/ec-de-tamiflu.pdf.

This view will have important consequences not only for generic  
Tamiflu manufacturers but also for any European country that issues a  
compulsory license for any drug, including high priced cancer or AIDS  
drugs, which might be available for import from a domestic or foreign  
generic supplier. It essentially means that compulsory licenses  
become a nearly worthless tool in Europe for a decade on any new drug.

Why? As a condition of selling drugs, the EU ( and Member States)  
require pharmaceutical sellers to submit information, ' registration  
data', showing their drugs are safe and effective e.g clinical trials  
and other studies. To gain regulatory approval to sell generic  
versions of drugs, generic companies generally do not repeat these  
studies, which are costly and time consuming. Instead, they rely on  
the registration data submitted by the original applicant ( the  
patent owner) to establish the bio equivalence (meaning it will work  
the same way in the body as the brand-name drug) of their generic  
follow-on.

However EU law grants the patent owner a period of exclusivity for  
this data . The rules are quite complex but in essence, these "data  
exclusivity rights" mean that the regulatory authority can't use the  
patent holders data for 8 years to approve a generic drug, and the  
generic company must wait another two years before it can actually  
market the product. In other words, a generic manufacturer can't  
place its drug on the market for 10 years from the date of the  
original approval, unless the patent owner agrees they can use the data.

If the generic manufacturers are not able to rely on this data, in  
many cases they simply will not enter the market, as the only option  
would be to repeat the testing. In a health emergency it would not  
make sense to do so, for time reasons alone, as clinical trials  
ordinarily take 6-8 years to complete.

Thus, the result of these rules is that generic manufacturers will  
effectively be barred from entering the market, even if the  
Commission or Member States have issued compulsory licenses ( which  
lifts patent protection) for 10 years , until the monopolies on data  
and marketing end.

The Commission has confirmed in its letter that these rules would not  
be lifted even in an emergency. Nor would it be lifted if there was  
abusive behavior by the patent owner like excessive pricing.

So what does this mean for the stockpiling of Tamiflu? If the  
Commission decided to issue a compulsory license, for example because  
Roche could not make an adequate supply of Tamiflu , a generic  
manufacturer would not be able to rely on Roche' s registration data  
and would be unable to market the drug until the 10 year period had  
ended. Unless of course, Roche agreed. If Roche does not agree, or  
seeks to delay giving approval, the Commission does not have the  
power to override these exclusive rights.

So, under current rules, the Commission appears happy to hand  
decisions on, and control of, the production of alternative supplies  
of oseltamivir to the existing monopoly supplier, who can't meet  
demand and who has little incentive to allow competitors to produce  
such alternatives.

Such is the state of emergency health planning in the EU today.

Read on:
explanation of the EU's Data Exclusivity Rules
: http://www.annamckay.com/article10.html

The European Generic Medicines Association
http://www.egagenerics.com/
posted by michelle at 6:05 AM
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---------------------------------
James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /  
tel. +1.202.332.2670 / mobile +1.202.361.3040

"If everyone thinks the same: No one thinks."  Bill Walton