[Ip-health] Fedefarma asks USTR to put Guatemala on 301 list

[Mike Palmedo]

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[ Picked text/plain from multipart/alternative ]
http://www.ustr.gov/assets/Document_Library/Reports_Publications/2007/2007_=
Special_301/asset_upload_file146_10571.pdf

FEDEFARMA=92s position on Guatemala referring to Special Chapter 301

The DR-CAFTA established the commitment of Guatemala to implement measures =
=96 in procedures relating to the market approval of pharmaceutical product=
s =97 to avoid that the marketing approval of a product covered by an inven=
tion patent or its approved use in effect in the country, be authorized wit=
hout the express and prior authorization of the patent right holder (patent=
 linkage). The DR-CAFTA also includes specific provisions for effective tes=
t data protection.

Through Decree 11-2006, such obligation was assigned to the competent admin=
istrative authority (Departamento de Registro y Control de Productos Farmac=
=E9uticos y Afines, Ministerio de Salud P=FAblica y Asistencia Social).

Further implementation of such legal regulation required the amendment of e=
xisting regulation on pharmaceutical products (Decree 712-99) by means of G=
overnment Agreement 351-2006, requiring that, in the case of market approva=
l applications for new products, products that are not new and products und=
er a new pharmaceutical form, a sworn Statement, certified by a Notary, be =
attached, in order to legally declare the patent status of the active ingre=
dient of a product for which a new registration is being required

Nevertheless the Department of Registration of Registration and Control of =
Pharmaceutical and Related Products, acting beyond its scope and responsibi=
lities, issued in December 2006 a =93Simplified Procedure for the Reference=
d Health Inspection Certificate of Pharmaceutical Products=94. In this docu=
ment, the aforementioned Department established a procedure and the specifi=
c requirements applicable to filings for market approval of medicines that =
it refers to as =93sufficiently well known=94 in which it regulates the pro=
cedure and registration requirements of products of this type, thus modifyi=
ng Agreement 351- 2006.

These provisions override a Presidential Decree, which is obviously illegal=
 and unconstitutional and represent a clear attempt to circumvent already a=
cquired commitments on Intellectual Property Protection, setting back the c=
ountry=92s standards on this matter.

For such reason, we recommend Guatemala should be put in the Watch List of =
Chapter 301 and, if needed, an out of cycle review should be performed by t=
he USTR.

Guatemala, February 8, 2007

Federacion Centroamericana de Laboratorios Farmaceuticos:

ABBOTT
ASTRA ZENECA
BOEHRINGER INGELHEIM
BRISTOL MYERS SQUIBB
ELI LILLY
GLAXO-SMITHKLIINE
JANSSEN - CILAG
LEO PHARMA
MENARINI
MERCK SHARP & DOHME
PFIZER
ROCHE
SANOFI =96 AVENTIS
SCHERING GUATEMALTECA
SCHERING PLOUGH
WYETH

Mike Palmedo
Research Coordinator
Program on Information Justice & Intellectual Property
American University, Washington College of Law
T - 202-274-4442 | F - 202-274-4226 | mpalmedo@wcl.american.edu