E-DRUG: WHO Model List of Essential Medicines and Patents
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Dear all,
The question frequently comes up: "How many medicines on the Model List
of Essential Medicines are on patent?". Amir Ataran has recently
published a paper in which he stated that 98% of the medicines on the
Model List are off patent in 65 developing countries, so patents are no
problem for access to essential medicines. Is this true?
The below text is taken from a letter I have recently written in response to a question by the Indian Drug Manufacturers Association, which gives our official position in this regard.
"In response to the questions in your letter of 18 February 2005, I
would like to present the following explanation with regard to the
patent status of medicines on the WHO Model List of Essential Medicines
(the "Model List").
Essential Medicines
According to the official WHO definition, essential medicines are those
that satisfy the priority health care needs of the population. They are
selected with due regard to disease prevalence, evidence on efficacy and
safety, and comparative cost-effectiveness. Essential medicines are
intended to be available at all times, in adequate amounts, in the
appropriate dosage forms, with assured quality, and at a price the
individual and the community can afford. The implementation of the
concept of essential medicines is intended to be flexible and adaptable
to many different situations; exactly which medicines are regarded as
essential remains a national responsibility.
The Model List and national lists
The WHO Model List of Essential Medicines has been updated every two
years since 1977 and serves as a model for national lists of essential
medicines. The 13th Model List of 2003 contains 316 active substances
and is closely linked to WHO's clinical guidelines. National lists of
essential medicines are based on national treatment guidelines, and are
intended to guide supply and reimbursement of medicines in the public
sector and to focus training programmes, medicine information, quality
assurance and local production.
The Model List and patent status
Before 2002 the selection of medicines on the Model List was partly
guided by considerations of cost, and patented medicines were rarely
included in the list. Since 2002 patent status and costs are no longer a
selection criteria; besides comparative effectiveness and safety, the
main considerations are now public health value and comparative
cost-effectiveness within a therapeutic group. Examples of recently
included medicines are azythromycin and antiretroviral medicines (ARVs).
No general statement can be made on the number or proportion of patented
medicines on the Model List. Firstly, global patents do not exist; most
patents are national and some are regional. For this reason patent
status is always linked to a geographical area. Secondly, several
medicines which were patented in some countries at the time they were
included on the Model List, may no longer be on patent; they may not
have been patented in other countries because there no patent protection
was available in the country or no application was filed. A statement on
the percentage of patented medicines on the Model List is therefore not
possible without specifying the geographical area and the specific time.
Where does the figure of 98% come from? In a recent study Attaran has
checked the patent status of all medicines on the Model List in 65 low-
and middle-income countries. He concludes that only 17 medicines on the
list are patentable, although usually they are not actually patented,
and that overall patent incidence is only 1.4%. This leaves 98% of
medicines on the Model List off-patent in 65 low- and middle income
countries.
There are two arguments against this calculation. Firstly, the
assumption that all patents in all countries in the study are of equal
economic importance is wrong. Most patents are strategically placed to
protect the largest markets and those with production capacity. But
these patents indirectly also affect markets in smaller and poorer
countries, because generic manufacturers need production in the larger
markets in order to export to the smaller ones. If a percentage
calculation is to be used, it should therefore be based on the
population size, not on the number of countries. An additional factor
would be needed for the export potential of countries with production
capacity. Patents in producing countries such as India may not be of
equal importance as those in non-producing countries. In this case, not
all countries are equal. If patents exist in only 2 countries out of
100, but these 2 are large producing countries, patents would certainly
be a barrier to access.
Secondly, counting the number of countries with registered patents as a
statistical exercise is also misleading from a public health point of
view. Countries are different in size and have different diseases
burdens. For example, a patent on ARVs in South Africa has much more
public health impact then one in a small country or one with few
HIV/AIDS patients.
Thirdly, not all medicines on the Model List are of equal medical
importance. For some medicines on the list which are under patent in the
originator country, off-patent alternatives exist on the list which
could be used instead. This is not the case with most of the newer
essential medicines on the list, such as ARVs. It will also not be the
case for new medicines against HIV/AIDS, malaria and tuberculosis or
other neglected diseases, which are currently under development. In
addition it should be noted that a few patented medicines can greatly
affect health expenditure. For example, the Brazilian National AIDS
Programme has 14 ARV medicines, but 3 patented products account for 63%
of the total programme expenditure. Finally, a patent on one medicine
may also reduce access to an important treatment, as in the case of
fixed dose combinations.
Practical implications for India
For the Indian market it is not Attaran's global figure but the patent
status of medicines in India itself which is of primary concern, as this
defines the legal possibilities for domestic production and marketing.
The number of medicines on the WHO Model List which is currently under
patent in India can easily be calculated. However, from a national
public health perspective it is more relevant to look at the number of
patented medicines on some of the influential state-level essential
medicines lists, such as those of Delhi SCT or Maharashtra. Yet these
figures would suffer from the same limitations as Attaran's percentage,
because they also do not reflect the differences in economic and public
health importance between the various patents.
With regard to export, many of the low- and middle-income countries
included in Attaran's study depend heavily on the importation of generic
essential medicines from India. The legal possibilities for export to
these countries depend on the patent status in India and in these
countries; and on the presence of voluntary or obligatory licenses.
Attaran's figure suggests that most generic medicines can be exported
from India to most developing countries, and this is basically correct.
It is also correct that most prevalent diseases can be treated with
existing generic medicines; and that access to existing medicines is one
of the major obstacles to better health in developing countries.
And yet this picture is incomplete. The few patents that are registered
are strategically placed and have much more economic and public health
impact than is being suggested by the 98% figure. Although the
arithmetic may be right the economic value and public health importance
of the market of ARVs and future essential medicines for neglected
disease are buried in the statistics."
Dr Hans V. Hogerzeil
Director
Medicines Policy and Standards
WHO Geneva
hogerzeilh@who.int