The gist of the US proposal is that when data is submitted for pharmaceutical marketing authorization for a new product, a third party cannot piggy back on that data for at least five years: E.16(a). If the chemical entity has previously been approved as part of another product, the period is reduced to three years: E.16(c). The majority proposal simply requires that such data be protected against “unfair commercial use.” No minimum period of data exclusivity is specified. Furthermore, under the majority proposal, the protection may be limited to new chemical entities – that is, no protection at all would be permitted if the chemical entity has been previously approved as part of another product, even if new data is required – and it may also be limited so that data protection is not available for new uses, or dosage forms, again, even if new data is required. There are also some other potential limitations on the data exclusivity. (Both proposals safeguard any measures necessary to implement the Doha Declaration on the TRIPS Agreement and Public Health.)
I am generally inclined to think that data protection is sound as a matter of policy. The argument for data protection is the same as the argument for intellectual property generally; the data is difficult and expensive to create (both proposals are limited to data “the origination of which involves a considerable effort”), and it is easy to copy, and without some form of protection no one will have an incentive to originate the data in the first place. Unlike patent protection, data protection does not have any requirement of an inventive step, but on the other hand, it does not provide a true monopoly either. In my view the inventive step requirement in patent law is designed to ensure that a monopoly is not granted over inventions that would have been independently developed in any event: Graham v John Deere Co, 383 US 1 at 11 (1966). Since data protection does not prevent applications for marketing authorization based on independently created data, this problem does not arise. On this logic, the potential exclusions for new uses of known entities, drugs that have not been approved in other formulations, or new dosages, are difficult to justify. If the data required significant effort to originate, and it is susceptible of piggy-backing, then it should be protected.
Of course, the bigger debate between the two positions is as to whether there should be a minimum period of data protection. If we accept the basic justification for data protection, which the majority proposal apparently does, then a minimum period of protection seems necessary in practice to make that protection effective.
The positions are set out below for convenience:
Article QQ.E.XX.4: {Protection of Undisclosed Data}
NZ/CA/SG/CL/MY/VN propose:
1. Where a Party requires, as a condition of marketing, regulatory or sanitary approval for pharmaceutical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, that Party shall protect such data against unfair commercial use. In addition, each Party shall protect such data against disclosure, except where necessary to protect the public or unless steps are taken to ensure that the data is protected against unfair commercial use.
2. Each Party may provide that the protection of data under paragraph 1, inter alia:
(a) is limited to undisclosed test or other data, the origination of which involves a
considerable effort;
(b) is limited to pharmaceutical products that do not contain a new chemical entity that
has been previously approved for marketing in the Party;
(c) is limited to pharmaceutical products which utilize a new chemical entity;
(d) is available only once per pharmaceutical product;
(e) is not available for new uses or indications, new dosage forms or methods of making a
pharmaceutical product;
(f) is limited to a period of time as determined by the Party; or
(g) may be waived to facilitate the marketing, regulatory or sanitary approval of a
pharmaceutical product that is the subject of a voluntary or compulsory license, or a
licence otherwise issued pursuant to the TRIPS Agreement.
3. Each Party may take measures to protect public health in accordance with:
(a) the Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2)
(the “Declaration”);
(b) any waiver of any provision of the TRIPS Agreement granted by WTO Members in
accordance with the WTO Agreement to implement the Declaration and in force between
the Parties; and
(c) any amendment of the TRIPS Agreement to implement the Declaration that enters into
force with respect to the Parties.]
US propose; AU/PE/VN/NZ/CL/MY/SG/BN oppose:
1. (a) If a Party requires or permits, as a condition for granting marketing approval for a new pharmaceutical product, the submission of information concerning the safety or efficacy of the product, the origination of which involves a considerable effort, the Party shall not, without the consent of a person previously submitting such safety or efficacy information to obtain marketing approval in the territory of the Party, authorize a third person to market a same or a similar product based on:
(i) the safety or efficacy information previously submitted in support of the marketing
approval; or
(ii) evidence of the existence of the marketing approval,
for at least five years from the date of marketing approval of the new pharmaceutical product in the territory of the Party.
(b) If a Party requires or permits, in connection with granting marketing approval for a new pharmaceutical product, the submission of evidence concerning the safety or efficacy of a product that was previously approved in another territory, such as evidence of prior marketing approval in the other territory, the Party shall not, without the consent of a person previously submitting the safety or efficacy information to obtain marketing approval in the other territory, authorize a third person to market a same or a similar product based on:
(i) the safety or efficacy information submitted in support of a prior marketing approval in
the other territory; or
(ii) evidence of the existence of a prior marketing approval in the other territory,
for at least five years from the date of marketing approval of the new pharmaceutical product in the territory of the Party.
Submission of New Clinical Information or Evidence relating to a Pharmaceutical Product that Includes a Chemical Entity that has been Previously Approved for Marketing in Another Pharmaceutical Product
(c) If a Party requires or permits, as a condition of granting marketing approval for a pharmaceutical product that includes a chemical entity that has been previously approved for marketing in another pharmaceutical product, the submission of new clinical information that is essential to the approval of the pharmaceutical product containing the previously approved chemical entity, other than information related to bioequivalency, the Party shall not, without the consent of a person previously submitting such new clinical information to obtain marketing approval in the territory of the Party, authorize a third person to market a same or a similar product based on:
(i) the new clinical information previously submitted in support of the marketing
approval; or
(ii) evidence of the existence of the marketing approval that was based on the new clinical
information,
for at least three years from the date of marketing approval based on the new clinical information
in the territory of the Party.(d) If a Party requires or permits, in connection with granting marketing approval for a pharmaceutical product of the type specified in subparagraph (c), the submission of evidence concerning new clinical information for a product that was previously approved based on that new clinical information in another territory, other than evidence of information related to bioequivalency, such as evidence of prior marketing approval based on new clinical information, the Party shall not, without the consent of a person previously submitting such new clinical information to obtain marketing approval in the other territory, authorize a third person to market a same or a similar product based on:
(i) the new clinical information submitted in support of a prior marketing approval in the
other territory; or
(ii) evidence of the existence of a prior marketing approval that was based on the new
clinical information in the other territory,
for at least three years from the date of marketing approval based on the new clinical information
in the territory of the Party.Additional Provisions relating to Pharmaceutical Products
2. Notwithstanding paragraph 2 above, a Party may take measures to protect public health in accordance with:
(a) the Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2)
(the “Declaration”);
(b) any waiver of any provision of the TRIPS Agreement granted by WTO Members in
accordance with the WTO Agreement to implement the Declaration and in force between
the Parties; and
(c) any amendment of the TRIPS Agreement to implement the Declaration that enters into
force with respect to the Parties.
3. A Party that requires or permits an applicant to obtain approval for marketing a new pharmaceutical product in its territory by relying, in whole or in part, on the prior approval of the pharmaceutical product by the regulatory authority in another territory may, as a condition for providing the period of data protection specified in subparagraph 2(b) or 2(d), require an applicant that has submitted an application for marketing approval consistent with said subparagraphs to commence the process of obtaining marketing approval for that pharmaceutical product within [X] years of the date of first marketing approval of the same pharmaceutical product in another Party.
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