By
recognizing the gravity of the public health problem in many developing
and least-developed countries (75), Members, agreed that
the WTO Agreement on TRIPS "does not and should not prevent Members
from taking measures to protect public health," and "affirm
that the agreement can should be interpreted and implemented in a manner
supportive of WTO Members' right to protect public health and, in particular,
to promote access to medicines for all." (76) The
declaration also affirms "the right of WTO members to use, to the
full, the provisions in the TRIPs Agreement, which provide flexibility
for this purpose." (77) The flexibilities include
"the right to grant compulsory licenses and the freedom to determine
the grounds upon which such license are granted", "the right
to determine what constitutes a national emergency" (including HIV/AIDS
crisis as public health emergency), and the freedom to implement the exhaustion
doctrine. The Doha declaration reaffirms use of the exhaustion doctrine
under Article 6 of TRIPs by stating that the purpose is "to leave
each Member free to establish its own regime for such exhaustion without
challenge, subject to the MFN and national treatment provisions of Article
3 and 4." (78)
This statement from the Doha Declaration means that developing
countries can issue compulsory licensing or/and allow parallel imports
(by implementing the international exhaustion doctrine) for public health
reason, without fear of invoking legal challenges from other WTO members,
particularly the U.S.(79) Moreover, under Doha all least-developed
countries have an additional ten years transition period, until 2016,
to comply with pharmaceutical patents(80).
VI. The Unresolved or Remaining Problems after The Doha Conference
As the result of the Doha Conference, developing countries
can issue a compulsory license or/and allow parallel imports (by implementing
the international exhaustion doctrine) for public health reasons without
fear of legal challenges from other WTO members. However, the U.S. still
exerts pressure on developing countries to strengthen their patent protection
on drugs because the volume of trade and profits from pharmaceutical sectors
are large enough to get a close attention from both private and government
agencies.
Although WTO Members recognized the issue of the limited
pharmaceutical production capacities in developing countries, there has
been no real resolution of this issue over whether developing countries,
which cannot produce generic medicine by themselves, can issue a compulsory
license to a company in another country to produce drugs for import into
the developing countries. This situation is called a `third party compulsory
licensing.(81) Indeed, in order to ultimately make compulsory
licensing more effective, the Doha Declaration should specify that members
are able to grant compulsory licensing to foreign manufactures to provide
medicines in the domestic market. If Article 31(f) is interpreted to allow
compulsory licensing only of domestic manufacturers serving the domestic
market, the compulsory licensing would prove to be of limited use due
to insufficient pharmaceutical production capacity in the developing nation.
Therefore, developing and least-developed countries with low technology
may be better off utilizing parallel imports instead of the compulsory
licensing to increase access to essential drugs. Developing counties may
be more secure from other countries' complaint against parallel imports
because issues over international exhaustion doctrine cannot be brought
to the WTO dispute settlement.
In comparison to compulsory licensing, parallel imports
may be a better solution for developing countries, particular countries
with low capacity to produce drugs. However, parallel importation still
presents the problem of how to find a source of low-priced drugs. The
low-priced drugs may be available in countries that provide a relaxed
patent protection or use compulsory licensing. Currently, developing countries
with production capacity such as India and Brazil have liberalized or
relaxed their patent laws in order to produce the low cost drugs. Nevertheless,
by the TRIPs deadline of 2005, these countries will have to raise their
patent law standard to meet TRIPs obligation and may no longer be a source
of parallel imports. In the case of compulsory licensing, developing countries
with production capacity may issue compulsory licensing to produce essential
drugs, but Article 31(f) of TRIPs Agreement only allows compulsory licensing
of domestic manufactures serving the domestic market. So drugs made under
compulsory licensing technically could not be imported for the need of
a foreign country. The TRIPs council should allow parallel importation
of compulsory licensed drugs. By relaxing on the interpretation of Article
31(f), the TRIPs Council should allow the strategy of the combination
between compulsory licensing following by parallel imports (which is making
drugs under compulsory licensing in one country and then import to another)(82).
Also under Article 31(f) the countries with insufficient technology to
manufacture drugs are not able to grant compulsory licensing to a foreign
manufacture to produce and only provide medicines for the developing country's
domestic market (known as a 'third party compulsory licensing'). WTO Members
recognized this problem and instructed the TRIPs Council to find an expeditious
solution before the end of 2002. Nevertheless, as of 2003, there has been
no satisfying solution because of intense disagreement among members on
this issue.
VII. Conclusion and Recommendation
The current TRIPs treatment on parallel imports is a
good sign for developing countries. Countries are allowed to choose the
exhaustion doctrine rule that will apply to parallel imports. This is
beneficial to developing countries, as TRIPs Agreement does not require
developing countries to apply a restrictive rule on parallel imports.
However, it would be more beneficial to developing countries if the TRIPs
Agreement specifically designated that the international exhaustion as
applicable international legal standard, which allows parallel imports
and supports the free trade. The current TRIPs Agreement incorporates
strong patent protections and the rigorous restriction on compulsory licensing
for pharmaceutical products. In relation to drug patents, liberalization
on the parallel imports of pharmaceutical products enables developing
countries to obtain medical drugs that are otherwise priced higher than
poor patients can afford(83). In other words, allowing
parallel imports in pharmaceutical products lessen the effect of strong
patent protections and the rigorous restriction on compulsory licensing
because the strong patent protection with limited utilization of compulsory
licensing causes an adverse effect on developing countries in terms of
high price and low availability of essential drugs. Comparing to compulsory
licensing, parallel imports may be considered the better solution for
developing countries to deal with the issue of inaccessible and unaffordable
drugs.
In brief, arguments for liberalizing parallel imports
of drugs focus on the consumers, social welfare and health policy concerns.
Allowing parallel import not only lessens the problems of affordable access,
but also reduces the volume of trade in counterfeit drug because consumers
will trend to buy genuine parallel imported drugs over fake version. `Ib
allow drug companies to stop parallel imports permits the companies to
capture a double benefit at the expense of poor people. Regarding humanitarian
concerns, drugs are not like other products since medicines are considered
a necessary thing for all humans. Indeed, increasing access to essential
medicines, such as the drugs for treatment of HIV/AIDS, benefits the entire
global community. The more available affordable drug treatments are the
less risk of infection world-wide.
As the result of Doha Conference, it obviously denotes
that on the basis of public health, developing countries can issue compulsory
license and allow parallel imports (by implementing the international
exhaustion doctrine) without phobia of legal challenges from other WTO
members particularly the U.S. They may expect that in area of public health,
the U.S. would reduce the intimidate action. However, because of having
dominant power to lobby the government and the high volume of trade and
profits from pharmaceutical sectors, the U.S. pharmaceutical industries
continually push the strong pressure to the government for impeding parallel
imports and compulsory licensing.
In the long-run TRIPS Agreement should allow members
to use a ‘third party compulsory licensing’ which grants compulsory
licensing to a foreign manufacture to produce and provide drug for the
need of domestic consumers. The third party compulsory licensing approach
differs from the combination of compulsory, licensing and parallel imports
since the former used no intermediary importers, thus avoiding price arbitrage.
The later requires parallel importers and results in price arbitrage.
The third party compulsory licensing approach is based on a straight pact
between government and a foreign manufacturer and the goods produced under
this licensing are directly exported from foreign country and import to
the country issuing the compulsory licensing. This approach appears to
be the best way to get a low-prices drug because, in the near future,
it will be hard to find sources of low-priced drugs for parallel importation.
Unfortunately, at present, ‘third party compulsory licensing’
is not allowed under the TRIPs Agreement. Therefore, parallel imports
should help developing countries with insufficient technology to access
to affordable essential drugs. In the short term, the combination of a
relaxed patent law and liberalization of parallel imports under TRIPs
may help to provide accessible low-priced drugs. Allowing parallel imports
as a temporary solution may help to fill the need of developing countries
in the intermediate term while the TRIPs Council works on providing a
long-term solution to the issue.
(75)
See Doha TRIPs and Public Health Declaration, supra note 70, at para 1.
(76) Id. at para 4.
(77)
Id. at pare 4 and para 5.
(78) Id. at para 5 and 5 (d).
(79) See Alan 0. Sykes, Article, Public
Health and International Law : TRIPS Pharmaceuticals, Developing Countries,
and the Doha "Solution," 3 CHI. J. INT'L L. 47 (2002). (answering
the question whether the declaration are bound in the dispute process
by explaining that the Doha Declaration principally interprets vague obligations
in the TRIPS Agreement, and does not seem to oppose any TRIPS provision.
The Doha Declaration is likely to influence interpretation of the TRIPs
Agreement.)
(80)
See Doha TRIPs and Public Health. Declaration, supra note 70, at para.
7.
(81) Id.at para. 6. Paragraph 6 states "We
recognize that WTO members with insufficient or no manufacturing capacities
in the pharmaceutical sector could face difficulties in marking effective
use of compulsory licensing under the TRIPS Agreement. We instruct the
Council for TRIPS to find an expeditious solution to this problem and
to report to the General Council before the end of 2002."; This problem
occurs because Article 31(f) of the TRIPs Agreement states that a product
made under a compulsory license is supplied predominantly to the licensee's
domestic market. Many developing countries lack or have an insufficient
capacity to manufacture medicines on their own. This problem had been
raised by developing countries. Developing countries argued "nothing
in this TRIPS Agreement prevents Members from granting compulsory licenses
for foreign suppliers to provide medicines in the domestic market... In
this respect, the reading of Article 31 (f) should confirm that nothing
in the TRIPS Agreement will prevent Members from granting compulsory licenses
to supply foreign market." See The Developing Country Group's Paper,
supra note 71, at para.34; In this matter, the EU supports developing
countries by suggesting that it should allow developing countries that
cannot produce drugs themselves to license a company in another country
to manufacture a given drug for export to the Member granting the compulsory
license. See The EU's Paper, supra note 71, at para.13.; and also see
Correa, Implications of Doha Declaration on TRIPS and Public Health, supra
note 55, at 19-22; and also see TRIPS, supra note 1, art.31(f). Article
31 (f) states "(f) any such use shall be authorized predominantly
for the supply of the domestic market of the Member authorizing such use."
(82) This strategy can be work if the TRIPs Council
agrees that the drugs made under compulsory licensing can be used not
only for domestic market but also for potential foreign markets. The combination
of compulsory licensing in one country and then parallel imports in another
country would work in a way to get inexpensive drugs where they are needed.;
see WATAL, supra note 12, at 325. (pointing out that Article 31(f) does
not rule out exports. However, exports will be permissible only to countries
where the product is not patented or where a compulsory license has been
issued to a local entity to import the product. Moreover, in relation
to parallel imports, it is dubious whether exports can be allowed to countries
that allow parallel imports. This argument applies also to the use of
compulsory license to import the patented product because the TRIPs Agreement
does not prohibit this.); and also see Corlos M. Correa, Patent Rights,
in INTELLECTUAL PROPERTY Arm INTERNATIONAL TRADE: THE TRIPS AGREEMENT
214-15 (Carlos M. Correa & Abdulqawi A. Yusuf, eds. 1998) (mentioning
that the text of Article 31(f) does not completely ban exports of products
covered under the compulsory licensing. In relation to the export market,
the partial limitation may not be applied in connection with compulsory
licenses on the grounds of anti-competitive practices under Article 31(k).
This notion is consistent with the U.S. practices because exports by a
compulsory licensee have been expressly permitted in the cases of license
granted in the U.S. to remedy anti-competitive practices.)
(83) See Carlors M. Correa. Intellectual Property
Rights, The WTO and Developing Countries: The TRIPS Agreement and Policy
Option 36 (2000).; and also see MASKUS. supra note 3, at 211-12.( pointing
out that in the perspective of developing and least-developed countries,
the restrictions on parallel import amount to non-tariff barriers to goods
that have legitimately been released from the control of IPRs owners.
Actually parallel imports play an important role in countering "abusive
price discrimination and collusive behavior based on private territorial
restraints.")
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