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Original, generic medicines and copy
Dr N Delepine Dr Alkhallaf,dr Z Lankri, Dr H Cornille
Paediatric Oncology Unit APHP
GEIRSO 2009 Milan 21 au 24 septembre 2009
Empirism. Pragmatism
Creation of an autonomous status
Generic medicines in Europe
March 31st, 2004, generic medicines acquire a real legal status in the directive 2004 / 27 / EC
Nevertheless,
should the patient be the center of the reflection,
the " reality of the facts shows that the development of the generic medicines and their usage derive from a certain economic opportunism "
( Cendrine Barthelmé)
Generic medicines in Europe
March 31st, 2004, generic medicines acquire a real legal status in the directive 2004 / 27 / EC
The Incentives in favour of this new type of medicines,
are mainly of pecuniary order :
subsidies to the doctors
premiums for the replacement to the pharmacists,
return on investment for the industrialists
Directive 2004/27/EC and Marketing authorisation (MA)
Sets up a procedure of abbreviated, specific MA for generic medicines
" A generic medicine of the reference medicine authorized by the community can be authorized by the proper authorities of Member states according to the directives 2001 / 83 / Ec and 2001 / 82 / Ec in the following conditions :
Directive of March, 2004
To specify the procedure of MA in direction of a lowering of this procedure for the applicant
Elaborated widely in favour of the making of generics
which benefits from all the possible opportunities
Directive of March, 2004
Which has henceforth the possibility of asking the laboratory
making of the princeps to communicate ,
the file of MA which will be used to obtain the new authorization
Directive of March, 2004
It’s not necessary for the laboratory making the generics
To give the results of preclinical and clinical tests
To give the file of MA for its generics
The Executive Director of AFSSAPS can exempt studies of bioavailability in Human, to demonstrate its bio-equivalence with a referent special medicine
The MA file is then a simple duplication of the file of AMM as used for the reference medicine
Legal regime of generic medicines
was built in such way to be the most flexible and the least forcing possible, for the actors
(industrialists, public authorities)
with considerable arrangements regarding the markets law and the possibility to get certificates to facilitate their development
Legal regime of generic medicines
was built in inverse order:
the legislator stipulates the results to be reached
before the means are developed
Community MA of generics
The criterion of safety, developed by the law of 1998 was not taken into account in the 2004 directives, in particular concerning excipients
Too much forcing towards the development of the market
This directive is more inspired by a market philosophy than by a sense of medical security
Community MA of generics and the precautionary principle??
It is a paradoxical attitude as far as we live in a society
which shows a zero tolerance for the " sanitary risks " ( C.B)
Generic medicines or the consecration of the opportunism in public health (Sandrine Barthelmé) report
The commercial logic prevails over the sanitary logic
The objective is not any more the patient but the cost cutting
Prevalence of the commercial logic, justifies itself
The strategies of the industrialists relieved by the economic incitements
Incitement in the development of generic medicines
The manufacturing of a generic medicine is interesting, the investment has to be profitable at short-term
" The price of the princeps must be enough brought up so that the generics maker can have a sufficient profit margin in spite of the decline of the price "
Incitement in the development of generic medicines
The princeps has to be a medicine enough prescribed to hope to increase the number of sales
No generic medicine for the rare diseases or the orphan medicines
Incitement in the sale of the generic medicines: the fixed price of "responsibility" (TFR)
The TFR was conceived to give responsibilities to the patient, to trigger his awareness
It consists in aligning the price of repayment to the price of generic medicine and,
consequently, to make chargeable to the patient the additional cost of the leading medicine (set up by the Health Ministry , Douste Blazy in October, 2003)
The stakes in the customized legal regime
The questioning of the precautionary principle as the foundation of the sanitary safety
Since the arrival of generic medicines modifications of the relationship maintained with the precautionary principle
Precautionary principle: at the origin of German inspiration at the end of the 60s: principle recognised by the community law (EC Treaty 1992)
In December, 2000, during the European council of Nice, extended to the health
Since the arrival of generic medicines modifications of the relationship maintained with the precautionary principle
" New techniques of risk management the logic of which is to protect the community against a risk of damages "
It is an anticipative principle
In generic medicines, the precautionary principle has lost its intensity
It stays in recession with regard to economic interests
Generic medicines or the "revisited" precaution ( C.B)
The apprehension of the notion of the risk conditions the dimensions of the precautionary principle
In generic medicine, this apprehension is reduced to its simplest expression
The generic medicines are the copy of a princeps, in principle without risks, explain the lowering of the procedure of M.A
But excipients can vary between the princeps and its generic medicine and even between several generic medicines of the same molecule
Distinguish the problems of " prescribability " and " switchability " prescription and replacement
If we begin a treatment for a patient who has never received a given medicine, there should be only few problems because the posology can be adapted according to the wished therapeutic effect
Problem when we pass from a shape to another one,
especially mattering for medicines with narrow therapeutic margin.
In this last case, it is advised not to pass from a speciality to the other one (Folia Pharmacotherapeutica, Feb. 2006)
More problems of pharmaco-vigilance reported
to active principles in excipients
to a bad traceability
to modifications of bioavailability
to confusions by the patient
To a bad information of the patients and doctors
In conclusion
Be careful to excipients, coloring or other being able to lead to an allergic reaction
The addition of an excipient or the change of a complex composition in excipients can raise problems especially in the case of chronic diseases well treated with the principal medecine
The replacement can be at the origin of confusions
PRECAUTIONS
Avoid the replacement for certain categories of population in particular the old and\or allergic persons
Avoid the replacement with medicines with narrow therapeutic margin
Avoid the replacement between generic medicines
PRECAUTIONS
Improve the criteria of realization of the studies of bioequivalence IMPOSE THEM
Privilege the replacement by generic medicines of composition and presentation identical to those of principal medicine princeps
Privilege generic medicine devoid of excipients with notorious effect
Common dangers for any medicines
Impose a absolute traceability for the products of the blood, the meat of beef, the single-use materials etc.
Impose the transparency of circuits
Where does lovenox come from : of China, of USA ?
Some originals can also be risk potentials
What to do ???
Legal references
Cendrine Barthelmé
Lawyer
La réglementation des médicaments
génériques, un interface entre droit
communautaire et droit national
euryopa
vol 46-2007
Institut européen de l’Université de Genève
September 2007
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