E cdip/15/inf/2 original: english date: january 8, 2015 Committee on Development and Intellectual Property (cdip) Fifteenth Session Geneva, April 20 to 24, 2015

Description of the ISP database

Our data construction begins with a list of pharmaceutical products given to us by the National Public Health Institute (ISP). In Chile, all pharmaceutical products that are to be sold on the domestic market have to be registered with the ISP. The registration includes the name of the product, the form and size in which it comes, the principal active ingredient, and the specific active ingredient being registered. That is, a product may have one or more entries in the database depending on whether it comes in multiple forms, or has multiple active ingredients. Because many active ingredients are useful in several products, there are far fewer active ingredients listed than there are products or ISP registration entries. In addition, the names of the same active ingredient are sometimes given in differing ways, which required us to standardize the names by hand.³⁴ We obtained the ISP register in October 2012, which means it includes only products that have been registered up to five years earlier or that had been renewed.

Between 1934 and 2012, there were 14,504 ISP registrations for 12,116 pharmaceutical products.³⁵ Of these, 2,630 contained an active ingredient that had not yet appeared in an ISP registration. Figure A1 shows three time series: all ISP registrations, those where the name of a drug appeared for the first time, and those where an active ingredient appeared for the first time. Until about 1975, each registration contained a new product and active ingredient; after this date the series begin to diverge and by the year 2000 the introduction of products with active ingredients that are new to the Chilean market begins to decline.
Figure A2 shows a distribution of the number of active ingredients per product. Almost 70 per cent of the products have only one active ingredient, and almost 90 per cent have 1 or 2. The products with more than 5 active ingredients tend to be things like multi-vitamins and minerals or alternative medicines. Figure A3 shows the distribution of the number of registrations associated with an active ingredient. About 37 per cent are registered only once, but 5 generics (ibuprofen, paracetamol, ascorbic acid, the antihistamine chlorphenamine maleate, and the decongestant pseudoephedrine) are registered more than 200 times.


Figure A1




Figure A2



Figure A3

ISP registrants

The ISP database contains the names and addresses of organizations that are registering the product, but of course they are not standardized.³⁶ Our first step was to standardize the names by removing such things at “LTD” and “S A”, but preserving the country associated with the name. This resulted in about 3,500 unique name-country combinations. These were examined by hand to correct misspellings and further standardize the names. The resulting list contained 2,322 unique name-country combinations. After cleaning, the largest number of companies associated with a single registration was 18 (for products Plavix and Adenosine, with much the same list of international firms plus the Chilean importers and quality control). The left hand panel of Table A1 gives the distribution of these organizations across countries, and the right hand side gives the same thing weighted by the number of times the organization appears in the registry.

Only 15 per cent of the organizations have a Chilean address, but 68 per cent of the entries are for a Chilean organization. That is, the average number of ISP registrations for a Chilean firm is much higher than for firms from other countries.³⁷ Chile is followed in both lists by the U.S., Argentina, Germany, and India. The presence of India suggests the importance of the generics market in Chile.

Table A1

One advantage of the ISP database is that it contains information on the role that each registrant plays in the production and distribution of the drug being registered. In many cases a registrant will perform more than one function, sometimes as many as five (packager, importer, distributor, quality control, and manufacturer). This fact explains why there are 104,612 entries in the database but only 67,687 unique ISP id-firm-country combinations. Table A2 shows the distribution of the various functions performed by the registrants, by broad geographical region (Chile, the rest of Latin America, the U.S. and Canada, Europe, and the rest of the world). With a few minor exceptions, the distribution looks reasonable: Chilean firms specialize in finished manufacturing, packaging, importing, distributing, and quality control, whereas foreign firms manufacture, serve as the source or licensor of the product, and occasionally package, especially if they are European or Latin American firms.

Table A2

As indicated in the introduction to this appendix, our main objectives in the data construction are twofold: 1) to link pharmaceutical products to the patents that protect the active pharmaceutical ingredients and processes embodied in the products; and 2) to link products to trademarks. The ISP provides us with data that contains information on products and active ingredients, that is, we have a database with all pharmaceutical products registered in Chile and the active ingredients that they contain. The challenge then consists in (a) finding all patents that protect the active ingredients contained in the products and in (b) linking trademarks to products and companies. We divide our discussion below into these two challenges.