E-DRUG: TACD recommendations on Pharmaceuticals and IP
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[copied from Pharm-Policy; WB]
The following is the text of the resolutions approved by the Trans
Atlantic Consumer Dialogue (TACD) that relate to intellectual
property and pharmaceutical drugs. For information about TACD see the
web page at http://www.tacd.org. The TACD meeting concluded on
February 12, 2000. There may be a final stylistic change by the TACD
secretariat before the recommendations are published on the TACD web
page.
The TACD resolutions covered several topics, including:
- Access to medicines in developing countries
- Data Exclusivity and Health Registration Data
- Pharmaceuticals: Early Working of Patents and
Research Exceptions
- Transparency of pharmaceutical economics
- Patents on Genetic Diagnosis
TACD represents more than 60 consumer groups in the
EU and the US, including all of the largest and
best known groups. It is funded by the EU and
US governments to provide a consumer perspective
in the negotations on the Trans Atlantic Economic
Partnership (TEP). In my opinion, the TACD
recommendations will be a very useful model for
policy statements.
Jamie Love <love@cptech.org>
<--------begin TACD recommendations---------------->
Pharmaceuticals - access to medicines in developing
countries
1. TACD recommends that public health considerations be
paramount in trade policies as they relate to access to
medicines.
The US and EU governments should review trade policies to
ensure that developing countries do not face trade
related barriers for access to essential medicines and
other medical technologies, in a manner consistent with
the World Health Assembly (WHA) Revised Drug Strategy,
EB103/4, which calls upon member countries:
(1) to reaffirm their
commitment to developing,
implementing and monitoring national
drug policies and to taking all
necessary concrete measures in order
to ensure equitable access to
essential drugs;
(2) to ensure that
public health interests are paramount
in pharmaceutical and health
policies; and
(3) to explore and
review their options under relevant
international agreements, including
trade agreements, to safeguard access
to essential drugs;
TACD asks the US, the EU and its member countries to
report back to the TACD on the steps taken to implement
the WHA Revised drug strategy in trade policy.
2. TACD supports the creation of a WTO Working Group on
Access to Medicines.
This working group would identify problems concerning
access to medicines, provide a public health framework
for the interpretation of key features of WTO agreements,
and evaluate and propose changes in the WTO rules that
would expand access to medicines.
3. TACD recommends the US, the EU and other developed
countries enter into an agreement to support far higher
levels of R&D for neglected diseases. Today there is
very little research and development on diseases such as
malaria, chagas disease and other illnesses that have an
impact on the poor. R&D efforts for neglected diseases
should be designed with access in mind, and address
issues such as reasonable pricing and the allocation of
intellectual property rights.
4. TACD recommends the US, the EU and its member
countries enter into agreements with the World Health
Organization (WHO) to give the WHO licenses to use
publicly funded health care inventions in developing
countries.
5. TACD asks the US and the EU to support patent
exceptions for the export of medicines. The EU and the
US should send communications to the WTO supporting
interpretations of WTO TRIPS provisions that would permit
patent exceptions for production of medicines for export,
when the legitimate rights of patent owners are protected
in the export market. For example, patent exceptions
should permit the production and export of a medicine to
a country that had issued a TRIPS compliant compulsory
license for medicine. A failure to address this issue
will substantially undermine the usefulness of compulsory
licensing of medicines in countries with small domestic
markets.
6. TACD demands that The US and EU governments stop
putting pressures on developing countries to adopt levels
of intellectual property protection for medicines that
exceed the requirements of the WTO TRIPS accord. This
is consistent with Article 1 of the TRIPS, which states
that WTO member countries "shall not be obliged to . . .
implement in their law more extensive protection than is
required by this Agreement."
Pharmaceuticals: Data Exclusivity and Health
Registration Data
1. TACD opposes the harmonization of data exclusivity
for pharmaceutical registration data to 10 years. The US
and the EU both provide periods of "data exclusivity" in
the regulatory approval of pharmaceutical drugs: in the
US this is 5 years, in the EU it is 10 years. The EU
period was originally designed to compensate for a lack
of patent protection on pharmaceutical in some EU member
countries, and the lack of patent protection on medicines
from biotechnology. This rationale is no longer valid
with the new WTO TRIPS rules that require broad patent
protection in all EU member countries.
2. TACD recommends that companies that seek data
exclusivity protections be required to disclose the costs
of investments. Data exclusivity provisions are part of
a growing class of sui generis forms of protection that
are designed to protect investment, rather than
innovation. Because data exclusivity isn't a reward for
invention (which is already rewarded by patents) but
rather a protection of investment, there should be
greater transparency of the basis for the protection and
a reasonable relationship between the investment and the
protection.
3. TACD asks the EU and the US to report on trade
disputes that are related to introduction of generic
forms of Paclitaxel in the EU Market. TACD should be
provided with copies of all correspondence and
memorandums that have been sent between the US and the EU
or its member countries on the trade related aspects of
Paclitaxel registration in the EU. The US and the EU
should also report to the TACD who invented Paclitaxel,
and who sponsored the clinical trials used for EU and US
marketing approval.
4. TACD asks the European Commission's DG Entreprise to
report on the barriers to entry for generic forms of
Paclitaxel in the EU market.
5. TACD asks DG SANCO to report on the public health
consequences of barriers to entry for generic forms of
Paclitaxel in the EU market.
Pharmaceuticals: Early Working of Patents and Research
Exceptions
1. TACD supports so called "Bolar" exceptions in
patent laws to permit firms to test generic drugs and
prepare data required for marketing approval by
regulatory agencies, prior to the expiration of a patent.
This is needed to ensure that consumers benefit from the
timely introduction of competition when patents expire.
Health and safety regulatory measures should not be
misused as a barrier against competition.
2. TACD asks the US and the EU to reject overly
restrictive interpretations of anti-discrimination
language in Article 27.1 of the TRIPS. Article 27.1
should not be interpreted as requiring a "one size fits
all" patent law. The language in Article 27.1, that
requires that "patents shall be available and patent
rights enjoyable without discrimination as to . . . the
field of technology," should not be interpreted as
preventing countries from addressing public interest
concerns in patents, when provisions to address those
public interest concerns are consistent with the TRIPS
framework. Article 30 of the TRIPS regarding exceptions
to patent rights should be interpreted to permit
countries to address public interest concerns, including
those specifically related to fields of technology.
3. TACD recommends that the EU not require Central and
Eastern European (CEE) countries to eliminate "Bolar"
exceptions from patent laws as a condition for EU
membership.
Pharmaceuticals: Transparency of pharmaceutical economics
1. TACD recommends the US and the EU governments
undertake the following measures:
i). Any application for data exclusivity should include
a disclosure of the costs of data collection.
ii). The EU and the US should require firms that market
pharmaceutical drugs in the US or the EU market to
disclose, for each product,
A. annual global (and national) revenues,
B. costs of clinical trials, disaggregated by
timing and nature of trial (Phase I, II, III, IV, etc),
the number of patents and the duration of the trial,
C. when the product involves licenses from third
parties, the royalty payments and terms, and
D. the role of the government in the development
of the drug, including the awarding of grants,
cooperative research and development agreements,
licenses, tax credits and other subsidies.
iii) Governments should publish data detailing the
government's own costs of conducting clinical trials,
which can be used as a benchmark for the cost of clinical
trials.
iv). The government should publish reports detailing
public expenditures on the purchase of products developed
initially with public funds.
2. TACD recommends that consumers and policy makers
obtain better information about pharmaceutical
economics. One of the most vexing issues in
pharmaceutical policy making is the paucity of data to
justify pharmaceutical industry assertions regarding drug
development costs, profit margins or other relevant
economic data. Governments have been negligent in
collecting independent data on pharmaceutical economics.
Accurate data on the economics of the pharmaceutical
industry are needed to evaluate a wide range of
government policies, including, for example:
i. patent extensions,
ii. pricing,
iii. market exclusivity for health registration
data,
iv. orphan drug market exclusivity,
v. compulsory licensing,
vi. government technology transfer policies,
vii. scope of patents, and
viii. taxes.
There is a substantial public interest in having more
detailed disclosures of private sector R&D investments,
to address such questions as what is the percentage of
R&D investments spent on development of new and
innovative products, as opposed to "me too" therapies?
How much of the private sector R&D budget is spent on
non-essential medicines? What is the private sector
allocation of spending between pre-clinical development,
clinical trials, and post approval R&D? How much R&D is
spent on tropical illnesses and other diseases that
affect the poor? How much did the drug benefit from
public subsidies?
TACD Position on Patents on Genetic Diagnosis
TACD asks the European governments to immediately apply
for compulsory licenses or to use patent exceptions,
permitted under the TRIPs agreement, to address
technologies used for the screening of genetic diseases.
Consumers and patients are harmed by unreasonable uses
of patents that monopolize the screening for genetically
determined diseases such as the BRCA1 and BRCA2 patents
associated with breast cancer. Public health authorities
and laboratories in Britain and Sweden say that
unreasonable use of such patents presents a threat to the
public health, and reduced access to screening
procedures.
TACD asks DG SANCO to report on the public health and
ethical consequences of patenting of genes and
technologies for screening of genetic diseases.