• Under global trade rules and U.S.
bilateral trade agreements, countries have access to medicines in their fight
against HIV-AIDS and other epidemics.
• The U.S. played a key role in the
Doha WTO Ministerial (Nov. 2001) reaffirmation that global trade rules allow
countries to decide what constitutes a health emergency and to issue compulsory
licenses to produce drugs needed to fight epidemics.
• In August of 2003, the U.S. led the work towards a WTO consensus that
allows poor countries wdomestic drug production capacity to issue compulsory
licenses to ithout import drugs needed to combat diseases such as
HIV/AIDS, malaria, tuberculosis and other infectious epidemics.
• The Morocco FTA will not affect
that country’s ability to take measures necessary to protect public health or to
use the WTO solution to import drugs.
• The Morocco FTA expressly states
that nothing in the IP chapter affects that country’s ability to take
measures necessary to protect public health.
o Specifically, the United States and
Morocco confirmed their understanding that the IP chapter does not "affect the
ability of either Party to take necessary measures to protect public health by
promoting access to medicines for all, in particular concerning cases such as
HIV/AIDS, tuberculosis, malaria, and other epidemics as well as circumstances of
extreme urgency or national emergency."
• The FTA also expressly states that it will not prevent effective
utilization of last year’s WTO consensus allowing developing countries that lack
pharmaceutical manufacturing capacity to import drugs under compulsory licenses.
• Stronger patent and data
protection increases the willingness of companies to release innovative drugs in
free trade partners’ markets, potentially increasing, rather than
decreasing, the availability of medicines.
o The U.S.-Jordan FTA, signed in 2000,
contained an intellectual property chapter that covered data protection.
o Since 2000, there have been 32 new
innovative product launches in Jordan, a substantial increase in the rate of
approval of innovative drugs, helping facilitate Jordanian consumers’ access to
medicines. .
o Since enactment of the FTA, the
Jordanian drug industry has begun to develop its own innovative medicines. This
is an example of how strong intellectual property protection can bring
substantial benefits to developing countries.
• Provisions governing importation
of patented products reflect existing Moroccan and U.S. law, and do not
require Morocco to do anything it does not already do.
o Morocco decided in 2000, well
before the FTA negotiations, not to permit parallel imports of patented
products.
o The FTA simply reflects current
law in the U.S. and Morocco. Both countries already provide patent owners
with an exclusive right to import patented products, including pharmaceuticals
but also all other types of patented products.
o Indeed, many innovative industries
and their employees in the United States -- high tech, chemicals, agricultural
inputs, engineering and manufacturing -- benefit from this long-standing
protection in U.S. patent law.
o The fact that the FTA reflects
principles already present in both Parties’ laws does not in any way lessen our
commitment to the Doha Declaration. In fact, in previous FTA negotiations with
developing countries that do not have parallel import restrictions in their
domestic law (e.g., Central America, Chile, and Bahrain), the final negotiated
texts do not contain provisions on parallel importation.
• "Data Protection" provisions in
the Morocco FTA are part of the broad framework to protect innovation.
o Before a drug can be sold, the drug
must first be approved by a regulatory agency, such as the FDA in the United
States, as being safe and effective.
o Regulatory approval is a long and
costly process designed to ensure the safety and effectiveness of the product.
􀂃 The FDA requires extensive testing
before it approves a drug.
􀂃 Clinical trials take an average of
7-10 years.
􀂃 The process is very risky. On
average, only 20-30% of drugs that reach the last phase of testing actually
receive approval.
o The data that results from these
tests are extremely valuable.
• Protecting such data is consistent
with longstanding U.S. and international practice.
o Global trade rules (the Trade-Related
Aspects of Intellectual Property, or TRIPS) already require protection for data
submitted for marketing approval. Article 39.3 of TRIPS requires countries to
protect such data against "unfair commercial use."
o Data protection provisions were also
included in many past trade agreements including the U.S.-Jordan FTA and the
U.S.-Vietnam Bilateral Trade Agreement – both negotiated by the previous
Administration – as well as in the NAFTA and all recent FTAs, including the
U.S.-Singapore FTA and the U.S.-Chile FTA, and many bilateral intellectual
property agreements.
o TRIPS does not specify a period of
time for protection - the Morocco FTA text is based on the standard for
protection in the U.S. – five years from the date of marketing approval. There
is no circumstance in which the FTA requires that an innovator receive a data
protection period longer than five years for new chemical entities.
o Competitors can apply for approval at
any time using their own data. After the period of protection is over, under
U.S. law, other producers can apply for marketing approval by relying on the
innovator’s data.
o Terms of protection vary around the
world. Virtually every OECD country provides data protection. While the US
protects data for 5 years, the EU protects data for 6-10 years.
o Data protection provides an incentive
to bring innovative drugs to developing countries, and after five years, test data used to certify an innovate drug can be used to approve a generic version.The Morocco FTA will not affect that country's ability to take measures necessary to protect public health.
[USTR shall seek to ensure] "that the provisions of any multilateral or bilateral trade agreement governing intellectual property rights that is entered into by the United States reflect a standard of protection similar to that found in United States law." - Trade Act of 2002, Section 2102 (b)(4)
