Network for Monitoring the Impact of Globalization and TRIPS on Access to Medicines, Meeting Report, 19-21 February 2001, Chulalongkorn University, Bangkok, Thailand - Health Economics and Drugs Series No. 011
(2002; 67 pages) View the PDF document
Table of Contents
Open this folder and view contents1. Introduction
View the document2. Highlights of opening address of Dr Supachai Panitchpakdi
Open this folder and view contents3. 1Globalization, TRIPS and Access to Pharmaceuticals
View the document4. Further Reading
View the document5. Template of selected model indicators for studying the impact of globalization and TRIPS on access to medicines
Close this folder6. Selected indicators for studying the impact of globalization and TRIPS on access to medicines
View the documentRespondent data
Close this folderContents
View the documentI. Definitions used in the template**
View the documentII. Trends in total pharmaceutical consumption
View the documentIII. Health care coverage
View the documentIV. Structure of public and private pharmaceutical prices
View the documentV. Regulations relating to intellectual property rights protection and marketing authorization
View the documentVI. Prices of pharmaceutical products
View the documentVII. Market share of domestic and foreign firms
View the documentVIII. Regulation of pharmaceutical consumption - A stakeholder analysis
View the document7. The Collaborating Centres
 

I. Definitions used in the template**

Bolar provision:

A “Bolar” provision provides exemptions to exclusive patent rights which permit the testing, using, making (not selling) of patented pharmaceuticals for the purpose of submitting information required for obtaining marketing approval prior to the date of patent expiration. Bolar exemptions facilitate the entry of generic competition because they allow generics manufacturers to submit their products for regulatory approval before the expiry of a patented invention. Without these exceptions, generic manufacturers can only submit their products for regulatory approval after the expiry of the patent term. A recent WTO dispute settlement panel (Canada - Patent Protection for Pharmaceutical Products) upheld the TRIPS consistency of the Bolar exemption provided there was no “stockpiling” of the patented product by the generic manufacturer.

   

Data exclusivity:

Data exclusivity provides a minimum term of protection for undisclosed information (test or other data), such as health registration data, used in the submission for the registration of a pharmaceutical product. Data exclusivity prevents a drug regulatory authority or any other national competent authority from relying on such data to assess further applications relating to the same drug until the expiry of exclusivity.

   

Domestic Firm:

A domestic firm is a firm in which nationals of a given country own no less then a 50% stake of the said firm.

   

Domestic Industry:

The domestic industry is the aggregate of domestic firms in a given country.

   

Drug Regulatory Authority:

A Drug Regulatory Authority is designated by the State to ensure compliance with regulations applicable to drugs: issuing of marketing authorizations, authorizations of dispensaries, etc.

   

Generic Drug:

A pharmaceutical product usually intended to be interchangeable with the innovator product, which is usually manufactured without a licence from the innovator company and marketed after the expiry of patent or other exclusivity rights. Generic drugs are marketed either under a nonproprietary or approved name rather than a proprietary or brand name. (Multi-source (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability, Quality Assurance of pharmaceuticals, Vol.1 page 65).

   

Generic substitution:

Practice of substituting a product, whether marketed under a trade name or generic name, by an equivalent product, usually a cheaper one, containing the same active ingredients. (World Health Organization. Indicators for Monitoring National Drug Policies, WHO/EDM/PAR/99.3).

   

Health care insurance coverage:

Voluntary and compulsory. Includes all forms of publicly and privately financed prepayment (i.e. tax based, insurance etc.) systems which pool risks among populations.

   

Market authorization:

An official document issued by the competent drug regulatory authority for the purpose of marketing or free distribution of a product after evaluation for safety, efficacy and quality.

   

Pharmaceuticals:

Excludes veterinary products, homeopathic products, and herbal products. Includes material for injection, syringes, needles, dermatologicals.

   

Protection of undisclosed information:

The submission of undisclosed information (test or other data) such as health registration data, is often used as a condition for approving the registration of pharmaceutical products. Article 39.3 of the TRIPS Agreement requires WTO Members to protect such data submitted for the registration of new chemical entities against unfair commercial use provided that their origination involves considerable effort. TRIPS does not require data exclusivity(see definition). It allows a national authority to rely on existing data to approve subsequent marketing applications for a similar product.

   

Public price:

Price at which drug is sold to the end user in the public health care system.

   

Private price:

Price at which drug is sold to the end user in the private health care sector. Includes both prescription and non- prescription medicines.

   

Tax:

e.g. local sales tax, value added tax and excise duties.

** For additional terminological clarification, those employing the template of suggested indicators should consult the glossary in Globalization and Access to Drugs, WHO/DAP/98.9

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