“[TRIPS’] impact is catastrophic and [will cause] a crazy rise in
prices of medicines especially that 83% of medicine raw material is imported
from abroad. Therefore, I demanded that the 200 medicines that have not be
registered so far to be registered.”
Under the various agreements
on TRIPS and public health Egypt had until 1 January 2005 to become TRIPS
compliant with regards to pharmaceutical products. In essence this means
ensuring that Egyptian legislation protects product and process patents for
pharmaceutical products and that this protection is extended to a 20 year
period.
Legislation has been enacted
and published in the Official Gazette by the Egyptian government to this
effect and has been suspended until 1 January 2005. While there has been a
heated debate about TRIPS and public health, especially access to essential
medicines, in Egypt much of the discussion has been based on an evident lack
in essential information.
One of the biggest
misconceptions appears to be the belief that registration of a drug before 1
January 2005 will exempt the drug from patent laws after the that date. Thus
the Minister of Health reportedly gave instructions to escalate the process
of registering medicines before the beginning of 2005 and the implementation
of TRIPS.
Dr. Mahmoud Abdel Maqsoud, Secretary General of the Pharmacists’ Syndicate
told the EIPR researchers that
when TRIPS comes into force, it will be applied to medicines
registered after
1/1/2005… but those available until 31/12/2004 will not be affected.
This is a view also shared
by Dr. Tharwat Basily, Chairman of the Board of Amon Pharmaceutical Company
and Member of the Shura Council
who says
Luckily, all the [medicines] available in the market will continue as
they are and the high prices will be applied only to what will be discovered
after 1/1/2005 which is a small number, 5 or 6 medicines in the first year,
the same second year, and the same on the third year…”
Thus the government has
given the impression that medicines registered before 1 January 2005 will be
excluded from patent protection after 1 January 2005. This is incorrect,
both under Egyptian law and under TRIPS.
Under TRIPS developing
countries that took advantage of the delayed implementation of TRIPS had to
operate a “post-box” to register patents that would come into effect after
the compliance deadline. This means, regardless of whether the medicine has
been registered before 1 January 2005 the government of Egypt has a duty
under international law to ensure patent protection for these medicines
after 1 January 2005 as long as the term of patent has not expired. A breach
of this duty could lead to Egypt being brought before the WTO dispute
settlement body. The new patents legislation, which is applicable to
pharmaceutical products as of 1 January 2005, does not imply that
registration of a medicine before the cut-off date excludes it from
protection.
Another issue that was
raised in the context of the TRIPS enforcement was the fact that most of the
medicines in Egypt are beyond patent protection as they have been
manufactured and marketed for more than 20 years. As Dr. Mostafa Ibrahim –
Chairman of CID company and former Chairman of the Cairo Branch of the
Pharmacists’ Syndicate said,
95% of our medicines in
Egypt have expired patents
and the TRIPS will not be applicable to them.
Indeed, according to the
data of the Egyptian patent bureau, around 10 percent only of the medicines
in the Egyptian market are still subject to patent protection, and around 90
percent have fallen in the public domain. Therefore, there is no reason for
the prices of non-patented drugs to increase if the functional component for
it can be supplied locally.
However, it
would be a mistake
to look at the situation through pink glasses and underestimate the value of
new drugs. Other arguments have been made about the impact of TRIPS on the
access to essential medicines in Egypt. Dr. Mohamed Ra'ouf Hamed, Professor
of Pharmacology of the National Authority for Drug Monitoring and Research
says that, “[n]ew medicines will be expensive, and with time the ability of
the average citizen from the middle class to buy medicines will decline.”
Dr. Mostafa Ibrahim concedes
that, “5% (of existing drugs) and some new medicines treating some diseases
[will be protected under the TRIPS].”
The result will therefore be
that prices of common drugs like Paracetamol will not change but drugs for
more serious, and often life threatening, diseases such as heart diseases
and cancer, will become more expensive. Older drugs, especially for such
life threatening diseases, are often less effective than new drugs. The
result could be that
Cancer medicines, cardiac drugs, and antivirals, these are the
medicines whose prices will skyrocket so much that the patient would rather
die than pay for them.
Ultimately, as TRIPS comes
into force and drug companies enforce monopolies over patented drugs the
question whether the currently patent protected drugs are 5 percent, 10
percent or more of all drugs used in Egypt will become irrelevant. Medicine
is fast evolving and in areas with a large outlay in research and
development (R&D) new drugs will continue to be produced at a fast rate,
especially considering new biological science techniques, as pointed out by
Dr. Ahmed El-Adawi, of the Arab Company for Drug Industries and Medical
Appliances (ACDIMA);
The TRIPS will have a great impact but not during the first few years.
We cover now 93% of the drug consumption… The simple medicines will not be
affected, but the remaining proportion will… It is naive to say that it will
have a small impact as the medicines we produce now will be obsolete in a
few years as the method of treatment itself changes especially after the
discovery of the human genom which determines when the person will get
cancer, when they will have sore tonsils… new drugs will be used in
prevention of diseases not treatment of diseases applying the maxim
‘prevention is better than cure’… the impact is inevitable.
Moreover, the negative
impact of the TRIPS will not only be mid or long term, it will have an
immediate effect with respect to many recent drugs for serious conditions
such as heart failure, HIV/AIDS and cancer as drug companies move to
consolidate their international monopolies over drugs for these conditions
in all major developing countries from Egypt to India and Brazil.
TRIPS compliance in January
2005, as part of an international enforcement of patent protection for
pharmaceuticals, will likely see the increase in international prices of
medicines as drug companies will not have to compete with generics
manufactured in Brazil or India.
International studies
stressed that the implementation of TRIPS will have a negative impact on the
pharmaceutical industry, hence the accessibility to and the prices of
medicines in developing countries.
The increase in prices of medicines after the implementation of TRIPS will
be due to the high cost of imported patented drugs or patented drug
components.
Another issue may be the
higher royalties claimed by international drug companies once they have
legally enforceable monopolies over drugs in developing countries.
The issue of drugs in light of the implementation of the ‘TRIPS’
agreement is very serious, as the possibility of an increase in prices of
medicines is closer in light of the many impacts of the agreement, which
will result in intensifying the problem of medicines in developing countries
in which a large proportion of the population do not have access to their
needs of medicines.
(107)
Finally, another issue that
may arise after Egypt has become bound by the TRIPS with regard to
pharmaceutical products is the effect on Egyptian drug companies. This will
affect not only private and public companies and their profit margin but may
also affect employment in the industry and have a negative impact on the
livelihood of workers.
EIPR researchers found
different opinions on the effect of TRIPS among experts during research. Dr.
Galal Ghorab, Chairman of the Pharmaceuticals Holding Company,
stressed that
the implementation of TRIPS will result in billions of dollars annual loss
because of the price differences and multinational pharmaceuticals’ monopoly
of the market.However,
Dr. Tharwat Basily, was of the opinion that
The impact of TRIPS is not [as negative] on the industry as it is on
the public… as of
1/1/2005 cheap [medicines] will not be available, only the expensive ones
will be. But who will bear the burden? The patient …. the problem will
appear gradually and only patients will feel it. The pharmaceutical industry
will be very slightly affected.”
Whatever the opinion of the
local industrialists is, TRIPS was designed to benefit Multinational drug
companies and it is likely to increase their monopoly over drugs in Egypt
and this may have the effect both of increasing prices and weakening local
manufacturing capacity. Not only will imported raw material become more
expensive as the international companies that produce it consolidate their
monopolies, but voluntary licenses may become more expensive and difficult
to obtain as international companies expand their exploitation of the
Egyptian market.
