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[e-lek] International Debate on Generic Medicines of Biological Origin

E-DRUG: International Debate on Generic Medicines of Biological Origin
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The South Centre recently published Research Paper No. 82: "The
International Debate on Generic Medicines of Biological Origin," authored
by Germ?n Vel?squez, Special Advisor on Health and Development of the South
Centre.
The debate on generic medicines is not new. What makes it different today
is that attacks levelled against biological products are couched in ever
more 'technical' and abstruse language that confuses even the World Health
Organization (WHO).

Innovative biological drugs, which have been introduced on the market in
the past 20 to 30 years, make up, in terms of numbers, no more than 2 per
cent of the WHO Model List of Essential Medicines but, in terms of cost,
account for 15 per cent to 20 per cent of national drug expenditure.

The high price of biological drugs stems mainly from two new factors:
first, a change in the pharmaceutical industry's approach to price-setting
and, secondly, the introduction of additional barriers to the entry of
generics into the market. In any debate on the impossibility of producing
'identical' drugs, it should be made clear that what is at stake is not
identical products but therapeutic equivalents. What matters to the
patient, after all, is whether or not the drug can prevent, cure or
mitigate the effects of the illness.

Download the research paper below:

The International Debate on Generic Medicines of Biological Origin <
https://www.southcentre.int/wp-content/uploads/2017/11/
RP82_The-International-Debate-on-Generic-Medecines-of-
Biological-Origin_EN.pdf>

 <https://www.southcentre.int/research-paper-82-november-2017/#_ftnref1>

CONCLUSIONS from the paper
The debate on generic medicines is not new. What makes it different today
is that attacks levelled against biological products are couched in ever
more 'technical' and abstruse language that confuses even the World Health
Organization.

Innovative biological drugs which have been introduced on the market in the
past 20 to 30 years(51) make up, in terms of numbers, no more than 2.5 per
cent(52) of the WHO Model List of Essential Medicines, but in terms of
cost, account for 15 per cent to 20 per cent of national drug expenditure.

The high price of biological drugs stems mainly from two new factors:
first, a change in the pharmaceutical industry?s approach to price-setting,
whereby prices no longer reflect the true costs of research and development
plus a reasonable profit margin. They are now based on the product?s
supposed ?value? to the pharmaceutical industry in terms of financial
speculation, not on its role in promoting public health. Secondly, high
prices are the result of the unjustified strengthening of intellectual
property rights and the introduction of additional barriers to the entry of
generic drugs into the market. Instead of clarifying the situation, WHO has
created a further obstacle by introducing a biological qualifier (BQ) that
unnecessarily assigns a unique code to each generic biological medicine.

It is a source of major concern that WHO has not issued international
guidelines based on the principle underlying the INN system, namely that:
'International Nonproprietary Names, also known as generic names, are
intended to be used as public property without restraint, i.e. nobody owns
any rights on their usage'.

In any debate on the impossibility of producing ?identical? drugs, it
should be made clear that what is at stake is not identical products but
therapeutic equivalents. What matters to the patient, as we have said, is
whether or not a drug can prevent, cure or mitigate the effects of the
illness.

Certain biological drugs have revolutionized the treatment of cancer,
arthritis and inflammatory bowel disease. Meanwhile, health-care costs have
skyrocketed, with huge profits accruing to pharmaceutical companies.

There are obviously differences between the reproduction of biological
products and that of chemically synthesized ones. However, there is no
reason why biological products cannot be reproduced under a clear set of
rules that protect patients while ensuring affordable access to all those
who need them.

Instead of biosimilars, interchangeable biosimilars or bioequivalents, why
not simply opt for biological generics?

We hope that WHO will succeed in issuing clear guidelines prioritizing
patient protection over the financial interests of pharmaceutical companies.

51 Human insulin was introduced on the market by Eli Lilly in 1982.
52 Eleven products as compared with thousands of chemically synthesized
products that flood world markets.

E-DRUG@healthnet.org
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