EU Preparations for possible Bird Flu Pandemic (2)
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. ( see previous post)
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/
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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