E-DRUG: India's probable data exclusivity - a critical analysis
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This is a fairly long analysis of the likely content of a proposal that
will be submitted in India concerning data exclusivity. The analysis is
intended to educate those who are interested in supporting India activists
who are opposing any form of data exclusivity on the basis that it is
TRIPS-plus, that it sets a bad international precedent, and that it delays
access and adds to the eventual cost of generic medicines.
A CRITICAL ANALYSIS OF INDIA'S PROBABLE DATA EXCLUSIVITY/DATA COMPENSATION
PROVISIONS
Professor Brook K. Baker, Health GAP, October 20, 2006
I. INTRODUCTION
According to recent reports, on August 6, 2006, the Committee for the
Protection of Undisclosed Information under Article 39.3 of the TRIPS
Agreement, under the chairpersonship of Ms. Satwant Reddy, Secretary,
Ministry of Chemicals and Fertilizers, finalized a proposal for a 5-year
term of data exclusivity for India. Although the precise terms of the
proposal have not yet been released to the public, an earlier version
discussed at an Inter Ministerial meeting on May 22, 2006, is likely to
have been adopted. Thus, it is important to analyze the severity of the
wound India is about to inflict upon itself and its own population in terms
of future access to affordable generic versions of new medicines.
Likewise, it is important to analyze the knock-on affect that reduced
access in India will have on poor consumers in other developing countries
that have historically relied on low-price Indian generic medicines of
assured quality, particularly in response to the global AIDS pandemic.
It would be logical to wonder why drug companies want data exclusivity
rights in India since they have recently won product-patent rights that
grant 20 years of patent protection, which ordinarily block generic
competition. The answer is in fact fairly straight forward smaller
research entities and even major drug companies have not always filed
patent application on drug innovations of uncertain value, especially in
developing country markets.(1) Patent applications are expensive because
of translation and filing fees and because annual patent maintenance fees.
Since an innovator will ordinarily file its patent application long before
safety and efficacy is established via clinical trials, the innovator may
not want to waste patent fees on what may be a dead-end product. Whereas
universities, small research companies, and even big pharma firms are
willing to pay patent application and maintenance fees in large markets to
hedge their bets and to preserve their monopoly interests - they are less
willing to do so in smaller markets. Moreover, because India did not
grant product patents until very recently, some drug companies responded
by delaying introduction of a newer medicine on the market. In essence,
traditional data exclusivity rules would have allowed drug companies to
exclude competitors even where they had not sought or been permitted to
patent their products.
Data exclusivity provisions, if added to the Indian Drugs and Cosmetic Act,
will prevent India's drug regulatory agency from referencing or otherwise
relying on registration data previously filed by innovator drug companies
in order to gain regulatory approval for therapeutically equivalent generic
versions. Under data exclusivity rules, the Indian drug regulatory agency
will have to pretend that the safety and efficacy of identical follow-on
products cannot be established via proof found in the originator's earlier
submission. As a consequence, generic companies would be forced to repeat
time-consuming, expensive, and unethical studies in order to receive
regulatory approval during the five-year period of exclusivity. These
added and unnecessary costs, delays, and ethical concerns virtually
guarantee that no generic company will seek registration until the
exclusivity period has expired.
Even with safeguard exceptions for data compensation (discussed further
below), there might still be procedural delays and litigation bottlenecks
that could impede access and/or increase the costs of essential generic
products. India could avoid some of these consequences were it to adopt a
simple, non-appealable formula for data percentage-based royalties.
However, under more complex market-share compensation rules with required
negotiations, market-share assessments, and opposition and appeal
procedures, generic drugs could take years to come onto the market, and
medicines would be more expensive in the interim. Either form of
compensation adds to the eventual cost of medicines. On this ground and on
the ground that India can and should be a leader in avoiding TRIPS-plus
measures, India should avoid data-exclusivity even with a compensation
option.
The WTO TRIPS Agreement does not require data exclusivity, and thus India
is not obligated to adopt TRIPS-plus data exclusivity laws. The relevant
portion of the TRIPS Agreement, Article 39.3,(2) only requires protection
of expensive, undisclosed data submitted to drug regulatory agencies
against 'unfair commercial use', basically theft or commercial espionage.
Nowhere does TRIPS state that exclusive rights must be provided for a given
period. In fact, TRIPS makes clear that countries may decide for
themselves what constitutes 'unfair commercial use' and that there are many
possible approaches to satisfy this requirement. Permitting a drug
regulatory authority to do its job 'assuring the quality, safety, and
efficacy of medicines' is not unfair commercial use; it is a mandated
public service.(3)
The World Health Organization's Commission on Intellectual Property Rights,
Innovation, and Public Health recently reinforced the view that TRIPS does
not require data exclusivity:
Article 39.3, unlike the case of patents, does not require the
provision of specific forms of rights. It does not create property
rights, nor a right to prevent others from relying on the data for
marketing approval of the same product by a third party or from using
the data except when unfair (dishonest) commercial practices are
involved.
Prior to 1994, the U.S. tried to get its strict version of data exclusivity
into the TRIPS Agreement and failed - developing country negotiators simply
rejected its proposal. This 'legislative history' of failure, by itself,
should be enough to scuttle U.S.-inspired arguments that data exclusivity
is required. Moreover, many countries have rejected data exclusivity as
requirement of data protection and have instead adopted or continued more
minimal forms of TRIPS-compliant data protection. These countries have
never been challenged with a WTO complaint and for good reason - such a
complaint would surely be considered unmeritorious. If more proof is
required, the historic WTO Doha Declaration on the TRIPS Agreement and
Public Health ensures the primacy of public health and further ensures that
intellectual property rules do not interfere with promoting 'access to
medicines for all.' Even under U.S. law, the Trade Promotion Authority Act
of 2002 § 2102(b)(4)(C), the U.S. is required to uphold the Doha
Declaration.
The dangers of data-exclusivity on access to medicines is clear - poor
consumers in India and throughout the developing world will have reduced
access to the newest life-saving and life-enhancing medicines that is
routinely available to their rich counterparts. Even though data
exclusivity would not apply to all drugs, it would apply to the newest
medicines (those involving 'new chemical entities'), many of which
represent therapeutic breakthroughs, such as Atazanavir, an important
second-line AIDS medicine, and Tamiflu, a medicine believed to be effective
against avian/human influenza. If implemented in the manner proposed, data
exclusivity would apply to most of the important new medicines brought to
market in India in the future. Moreover, the USTR and the R&D drug
industry will continue to seek a shorter period of data exclusivity,
usually three years, for new formulations and new uses of known
medicines.(4) There's no reason that Indians should not have access to
affordable versions of the newest and most effective medicines even if
those drugs are relatively few in number.
II. CRITIQUE OF INDIA'S FIVE-YEAR DATA EXCLUSIVITY PROPOSAL
According to available reports, India's new data exclusivity proposal
contains several safeguard provisions and exceptions:
(1) Application to 'new chemical entities only';
(2) exclusivity period running from the date of first approval
anywhere in the world;
(3) requirement that a registration application be filed in India
within one year of first approval elsewhere;
(4) an exception for emergencies and public health crises;
(5) an exception for drugs of mass consumption, including for
HIV/AIDS, upon payment of a reasonable royalty;
(6) a compensation exception where repeat clinical trials would be
unethical;
(7) an exception for reliance on data submitted elsewhere (rare);
(8) a Bolar provision allowing applications for marketing approval
even during the period of data exclusivity;
(9) price control assurances;
(10) termination of exclusivity following a grant of a voluntary license
by the data originator; and
(11) termination of exclusivity upon patent-term expiration.
This section will analyze and critique each of these so-called safeguard
provisions.
1. Application to 'new chemical entities only'
By its express provisions, Article 39.3 requires data protection only for
'new chemical entities.' However, that term is not defined in TRIPS and it
is subject to broader or narrower interpretations.
Under broader interpretations, 'newness' would be considered only in the
context of whether chemical entity has previously been approved in a
pharmaceutical product in the Indian market. Under a stricter or narrower
interpretation, 'newness' would be considered in reference to any previous
approval or commercialization anywhere in the world. Likewise, newness
could be interpreted liberally or strictly with respect to variations in
the form of the chemical entity. Overly liberal definitions of new
chemical entities would encourage evergreening of data exclusivity by
introduction of minor variations in the base chemical entity. Strict
definitions would provide data exclusivity only once and only for truly
unique chemical entities.
India's current regulatory scheme with respect to registration is wholly
inadequate.(5) Nonetheless, India remains free to adopt its own
interpretation of 'new chemical entity' and could wisely choose the
narrowest possible definition,(6) such as the following:
A new chemical entity means a drug that contains no active moiety and
which has not been known to exist previously in India or any other
part of the world. For the purpose of this rule, active moiety means
the molecule or ion, excluding those appended portions of the
molecule that cause the drug to be an ester, salt (including a salt
with hydrogen or coordination bonds), or other noncovalent derivative
(such as a complex, chelate, or clathrate) of the molecule,
responsible for the physiological or pharmacological action of the
drug substance.
However, even this narrow definition could not prevent a likely period of
marketing exclusivity for many new and important pharmaceutical products.
2. Exclusivity from the first date of approval anywhere in the world
The May 22 data-exclusivity proposal contained a provision that the period
of data exclusivity would commence from the date of first approval of the
new chemical entity for pharmaceutical use anywhere in the world. Drug
companies at present routinely introduce their products first to
rich-country markets in the United States, Europe, and Japan. This
stop-the-clock provision would promote early introduction of the new
product to the Indian market by penalizing drug companies for their own
controllable delays in seeking product registration and marketing approval
in India. Although this clause would not eliminate the total five-year
period during which Indian consumers would not have access to the newest
medicines, it would ensure that they did not suffer interminable delays -
long delays in seeking approval followed by five long years of data
exclusivity.
3. Requirement that a registration application be filed within one year
of first approval anywhere in the world
A related provision requires that a drug company file its registration
application within one year or thereby lose its right to claim that the
chemical entity is new. In many respects, this provision would operate
like the one-year rule in the Paris Treaty, which allows innovators a
one-year grace period during which to file patent applications elsewhere in
the world after their initial, first filing. The one-year patent grace
period allows the patent applicant to claim novelty and to solve the
inevitable bureaucratic difficulties of multiple filings.
Although it is a positive restriction to grant drug companies a
one-year-only grace period rather than let them avoid a market for a long
time and then still seek data exclusivity long after the drug has been in
use elsewhere in the world, the one-year, use-it-or-lose-it grace period
does not ultimately shorten the five-year period of exclusivity.
4. An exception for emergencies and public health crises
The proposal is likely to have an express exception for publicly declared
emergencies and public health crises. Of course, there will be questions
about who or which agencies will be permitted to declare such emergencies
or crises and about their duration, but the larger question is why this
exception should be limited to extreme circumstances. It would be much
preferable if the data exclusivity provision, if any, would include an
express exception for any circumstance in which a compulsory license or
government use order has been issued in compliance with the India Patent
Act as amended in 2005. That Act permits specials procedures for
compulsory licenses granted to addressed emergencies and matters of extreme
urgency, but it also allows compulsory licenses on many other grounds:
government, non-commercial use, public health needs, competition, and
export to countries lacking domestic manufacturing capacity. None of these
flexibilities should be forestalled because of data exclusivity.
5. An exception for drugs of mass consumption, including for HIV/AIDS,
upon payment of a reasonable royalty
A compensation exception limited to medicines of mass consumption simply
does not make sense. The Gleevec case is a perfect example of a medicine
critical to the survival of a small number of cancer patients and where
monopoly pricing rendered treatment unaffordable except for the richest
minority. In fact, drug prices are often set higher for drugs with small
consumer bases. Patients suffering from relatively rare diseases have the
same interests as patients of pandemics in accessing affordable medicines.
If a compensation system makes sense at all - a contested issue - it only
makes sense if it is potentially available, and affordable, across a broad
range of products through an easy to administer system.(7) The major
justification for such a compensation system - even though it would be
TRIPS-plus - would be to counteract drug companies' claims that their
investments are being 'taken' without just compensation. The easiest to
administer system would be one involving a modest percentage royalty fee
based on Indian domestic sales without regard to the drug company's R&D
investment. A more complicated, and far less desirable, compensation
scheme could require computation of relevant research and development
expenditures and further calculations of market shares, and might even
involve requirements for royalty negotiations, opposition procedures, and
appeals. Such complex compensation schemes, even ones involving
arbitration, can be laborious and slow.(8) They also raise a troubling
degree of uncertainty about future costs that can greatly complicate
economic forecasting and market entry by generic companies.
Any and all royalty or cost-sharing compensation schemes are problematic
when compared to a baseline, TRIPS-compliant right to avoid data
exclusivity altogether. As a preliminary matter, it is well established
that major drug producers recoup their research and development
expenditures in rich country markets in the U.S., Europe, and Japan.(9)
Drug company profits continue to soar and continue to exceed R&D
investments even though there has not been data exclusivity or compensation
in most developing countries. Moreover, what drug companies call necessary
and related research and development is a highly contested matter. Much
drug research is focused on me-too drugs, on efforts to increase market
share, and on efforts to make misleading claims for expanded use. Finally,
research and development incentives from Indian market sales are
insignificant on a global scale - the entire subcontinent comprises less
than 1.3% of global pharmaceutical sales. Indeed, Africa and Asia combined
total only 5.1% of global sales and all developing countries lumped
together total roughly 11% of the global market.
In sum, the most desirable outcome would be no data exclusivity and no data
compensation. India should be a global leader in resisting TRIPS-plus
measures, particularly on a voluntary basis. If India stands up and
resists U.S.-sponsored pressure for data exclusivity that will embolden
other developing countries, including those involved in U.S. free trade
negotiations.
6. A compensation exception where repeat clinical trials would be
unethical
The truth of the matter is that clinical trials for generic equivalents of
previously approved pharmaceutical products will always be unethical.
Clinical trials are only justified where there is a legitimate scientific
inquiry concerning the safety and efficacy of an investigational new
product. However, once that safety and efficacy of the new product has
been established the only scientifically valid studies of the follow-on
equivalent are whether it is produced according to required quality
standards and whether it is therapeutically equivalent to the original
product, usually via bio-equivalence studies. The clinical-trial exception
makes it sound like there is some subset of medicines where unnecessary and
duplicative trials are ethical. To the contrary, exposing human subjects
to placebo-based clinical trials when the drug being investigated is
already known to be safe and effective is a gross violation of human rights
and investigational ethics and enormous waste of medical and economic
resources. It should not be tolerated let alone condoned.
7. A rare exception for reliance on data submitted elsewhere
India may well be advised to amend its drug regulatory scheme to permit
more reliance on previous registration by stringent drug regulatory
authorities or even on WHO pre-qualification. Vicarious reliance on the
work of other highly capable drug regulatory authorities would reduce the
burden on Indian regulators and also speed up the approval process. At
present, India requires separate clinical trials on Indian patients, but
this requirement seems unnecessary in the vast majority of cases. There is
little need for India-specific studies to establish safety and efficacy for
Indian people whose human biological diversity (and fundamental similarity)
closely matches that in the rest of the world.
Reliance on foreign registration may certainly be beneficial in
circumstances where a pharmaceutical product has not yet been brought to
the Indian market and a generic producer stands ready to produce, import,
or sell the product in India. (Note: the product's patent status in India
may adversely affect such an effort.) Alternatively, an importer could be
seeking to use parallel importation rights to import a previously
unregistered brand-name product. These producers or importers who are
striving to bring new drugs to the Indian market should not be forestalled
by the originator's reluctance or delay in seeking approval in India.
Thus, the idea that this should be a rare exception is probably misguided,
though it is also true that data exclusivity would not be an issue if there
were a more than one year delay in an Indian application for data
exclusivity (see point 3 above).
8. A Bolar provision allowing applications for marketing approval even
during the period of data exclusivity
The proposal is likely to contain a research exception and an exception to
permit applications for marketing approval during the period of data
exclusivity even though the actual grant will not occur until after the
period expires. Clearly, it is desirable to allow follow-on producers to
conduct research on product formulation, conduct stability experiments, and
undertake bioequivalence studies. This advance work can permit the generic
company to prepare a registration dossier for submission to the drug
regulatory agency even during the period of exclusivity. Under the
proposal the drug regulatory authority will be permitted to examine the
application and rely on data previously filed by the data originator, but
the drug regulatory authority will only be permitted to grant tentative
approval. Final approval will be granted only after the period of
exclusivity expires, but at the very least the new product might be brought
onto the market very quickly rather than having to wait for an additional
period of regulatory delay.
9. Vague price control assurances
Under the proposal, the Government says it will create a suitable mechanism
to ensure that the prices of such new drugs continue to remain reasonable
so that there is a wider coverage as far as the patients are concerned.
The details of this mechanism are unspecified, and without specifications
the threat of price controls offers little protection against the threat of
rising drug prices, especially since the record of Indian price controls is
not entirely reassuring. Moreover, since Indians continue to pay for the
majority of drug costs out-of-pocket, higher prices will inevitably lead to
lower usage, especially for poor Indian who live on less than $2/day.
10. Termination of exclusivity following a grant of a voluntary
license by the data originator
Any authorization of a generic by the data exclusivity holder would
automatically terminate data exclusivity for all producers. Whether the
authorization applies only to voluntary licensees or whether it also covers
the data holder's launch of a generic version of its own product is
uncertain. In the U.S., drug companies are beginning to launch official
generic versions of their own drugs shortly before patent expiration in
order to gain market share in the generic and in some instances to prevent
a competing generic from gaining six months of exclusivity under U.S. law.
There is no comparable, first-generic entrant rule in India, but the
proposed provision is designed to prevent de facto market share control by
the data holder and therefore to encourage entry by multiple generic
competitors. This competition will have a favorable impact on prices.
11. Termination of the period of data exclusivity upon termination
of the patent term.
India is proposing to ensure that the period of data exclusivity never
extends beyond the term of patent protection. This clause could be
significant for products that enter the market very late in their patent
term - a condition that may apply in the short term to drugs in the Indian
'mailbox' if there are additional long delays in granting patents
(post-1995 innovations have been held in India's mailbox until the new 2005
Patent Act Amendments.) This provision directly contradicts terms that the
U.S. is seeking in its free trade agreement negotiations, so India might
receive blow-back from U.S. authorities and PhRMA officials.(10)
III. CONCLUSION
India has attempted to soften the perverse effects of its unnecessary
adoption of data exclusivity by engrafting multiple safeguard provisions
and exceptions. Although it is true that these provisions ameliorate the
harshest features of the proposal and grant some exceptions to data
exclusivity, individually and collectively they do not mean that India is
making a wise policy choice. The TRIPS Agreement does not require a grant
of data exclusivity nor does the interest of India's own pharmaceutical
industry, which does not currently invest strongly in new chemical entity
research and which can recoup its investments through data exclusivity
granted in the U.S. and Europe. By granting data exclusivity, even with
safeguards, India is allowing another form of monopoly market protection
that will inevitably result in higher prices. Even worse, in some
identified circumstances, it will prevent effective utilization of
TRIPS-compliant flexibilities by preventing domestic registration of
medicines for which compulsory licenses have been granted. Although the
adverse policy consequences of this self-inflicted wound will fall
primarily on poor Indian consumers, the adverse consequences could be felt
in other developing countries as well. To the extent that Indian generic
producers rely on marketing rights in India in order to produce medicines
for exportation, domestic data exclusivity rules can deter generic entry
into the production-for-export market. Likewise, since some countries
require registration in the manufacturing country before granting marketing
approval for an imported drug, data exclusivity in India may further delay
life-saving access to generic medicines in other developing countries.
The best outcome would be for patients, public health and human rights
practitioners, AIDS activists, and other progressive political forces in
India to combine forces in opposing the adoption of data exclusivity.
International activists should support Indian opponents in their campaign
to resist U.S. and drug company pressure on India and to defeat data
exclusivity during the legislative process. This is a matter of urgency as
lives are at stake.
Endnotes:
(1) See, Shoibal Mukherjee, Here's a penny for your pill (8 August 2006)
available at
http://www.hindustantimes.com/onlineCDA/PFVersion.jsp?article=http://10.81.141.122
/news/181_1764059,00020008.htm#.
(2) Article 39.3 of the trips Agreement reads:
Member when requiring, as a condition of approving the marketing of
pharmaceutical or of agricultural chemical products with utilize new
chemical entries, the submission of undisclosed test or other data,
the origination of which involves a considerable effort, shall
protect such data against unfair commercial use. In addition, Members
shall protect such data against disclosure, except where necessary to
protect the public or unless steps are taken to ensure that the data
are protected against unfair commercial use.
(3) Carlos Correa, Protection of Data Submitted for the Registration of
Pharmaceuticals: Implementing the Standards of the TRIPS Agreement (2002);
cf. Aaron X. Fellmeth, Secrecy, Monopoly, and Access to Pharmaceuticals in
International Trade Law: Protection of Marketing Approval Data under the
TRIPS Agreement, 45 Harv. Int'l L.J. 443 (2004); contra G. Lee Skillington
& Eric M. Solovy, The Protection of Test and Other Data Required by Article
39.3 of the TRIPS Agreement, 24 Nw. J. Int'l L. & Bus. 1 (2003).
(4) Drug companies justify getting data exclusivity for new uses and new
formulations of old chemical entities to incentivize clinical trials into
expanded uses of previous medicines and into development of more
patient-friendly formulations. In some countries, such new uses and new
formulations will be patentable, but not under India's 2005 Patent Act,
unless they show significant therapeutic advantages. Accordingly, gaining
three-year exclusivity will be a high priority goal for the pharmaceutical
lobby and its USTR proxies - it will be the only way they can gain monopoly
status and market exclusivity for some of their unpatentable products.
(5) Under Rule 122-E of the DCA Rules (1945), a 'new drug' is defined as:
(a) a bulk drug substance which has not been used in the country to any
significant extent and has not been recognised as safe and effective by the
licensing authority; (b) a drug that is already approved by the licensing
authority which is now proposed to be marketed with modified or new claims,
namely, indications, dosage, dosage form (including sustained release
dosage form), route of administration; or (c) a fixed dose combination of
two or more drugs, individually approved for certain claims, which are now
proposed to be combined for the first time in a fixed ratio, or if the
ratio of ingredients in an already marketed combination is proposed to be
changed, with certain claims, namely, indications, dosage, dosage form
(including sustained release dosage form), and route of administration. For
the purpose of the Rules, all vaccines shall be new drugs unless otherwise
certified and a new drug shall continue to be considered a new drug for a
period of four years from the date of first approval or its inclusion in
the Indian Pharmacopoeia, whichever is earlier.
(6) See, Initiative for Medicines, Access & Knowledge, The Impact of
Article 39.3 in India: A Practical Perspective, 30 (2006); cf.
http://www.fda.gov/cder/about/smallbiz/exclusivity.htm.
(7) Judit Rius Sanjuan, James Love & Robert Weissman, A cost sharing model
to protect investments in pharmaceutical test data, CPTech Policy Brief No.
1 (Revised: 18 May 2006).
(8) I-MAK, supra note 6, has listed the following questions and concerns:
- How royalty standards are set. This would include identifying and
explicitly setting out the costs that would be subject to
compensation. For example, guidelines should be provided that clarify
whether costs relating to failed trials form part of an assessment
for compensation.
- What mechanisms would be utilised for government verification of
originator claims, possibly including the creation of a specific
authority set up under the Ministry of Health and/or Drug Controller
General in India.
- How to catalyse access to undisclosed information relating to the
cost of clinical trials and market-share data.
- What laws exist relating to the discovery of costs of clinical
trials and market share data.
- How to devise mechanisms that will monitor effectively the amount
of compensation the originator will receive, and whether the amount
exceeds the original investment.
- What cap should be set on compensation and the percentage of
original investment that can be recouped by originator, e.g. 80% as
suggested by Fellmeth. Effectiveness and Procedural Aspects of
Arbitration/Litigation
- How to ensure that production of medicines is permitted during
arbitration and litigation so that extended administrative procedures
do not become a bar to competition.
- Whether a specialist arbitration panel composed of public health
experts is needed for such arbitration.
- How to prevent delay by expediting arbitration and litigation in
compensation cases.
- How and whether appeals can be made from arbitration decisions.
- What the relative bargaining position of different market players
is likely to be at the commencement of arbitration, and how this will
affect competition.
- How to prevent 'gaming' of a market share system- for example, where
an originator refrains from selling a drug after obtaining marketing
approval, the generic company pays 100% of the costs of the data for
that drug.
- What the impact of artificial barriers will be to market entry on economic growth.
- Whether Indian industry is able to share in the costs of original
investment, given that clinical trials will often have been conducted
in the United States or Europe where costs are much greater, and
whether the expense for Indian manufacturers would be prohibitive.
- How market share will be measured, and when will it be measured,
because if assessments are not predictable, Indian manufacturers will
not be able to assess risks or costs/benefits and make informed
business decisions.
- Which Ministry will be responsible for monitoring implementation of
the cost-sharing model, and other significant administrative aspects
of this model, and how cumbersome these burdens will be to implement
in practice.
To this list one could add questions about whether market share will be
based on dollar volume of sales or pill volume of sales and how India would
acknowledge or assess market share of later entrants?
(9) See Donald W. Light & Joel Lexchin, Foreign Free Riders and the High
Prices of U.S. Patented Drugs, 331 British Med. J, 958-60 (2005).
(10) One of the primary rationales for data exclusivity from the U.S.
perspective is that it allows a guaranteed period of market exclusivity and
monopoly pricing even if a patent was never filed or if a granted patent
has expired.
Brook K. Baker
USA
B.Baker@neu.edu