Appeal Court issues Stay Order against Russian cancer drugs

By S.S.Selvanayagam

The Court of Appeal yesterday (28) issued a Stay Order suspending the registration and license to import the purported bio-similar drug known as '' Herticad '' which is a Russian product. The court also issued orders preventing administering of the said drug to cancer patients in Sri Lanka.

 The Bench comprising Justices Vijith K.Malalgoda (President of CA) and P. Padman Surasena issued Notices on the Respondents returnable for April 8.

 Petitioners F.Hoffmann-La Roche Ltd, a Swiss manufacturer of biotherapeutic materials and A.Baur & Co Ltd, Sri Lankan company engaged in the business, cited National Medicines Regulatory Authority, Health Ministry’s Medical Supplies Division Director, Director General of Health Services, President of the Maharagama Cancer Hospital’s College of Oncologists and Pharma Ace (Pvt) Ltd as Respondents.

 Manoj Bandara with Lakshana Perera instructed by Sudath Perera Associates appeared for the Swiss Manufacturer Company. Dinal Phillips PC with Ranil Prematilake instructed by Sudath Perera Associates appeared for the 2nd  Petitioner Company.

 The Swiss manufacturer Company claims that it innovated and manufactures the biotherapeutic product for medicinal use known under the International Nonproprietary Name (INN) “trastuzumab” as well as the trademark “Herceptin” in the treatment of Breast and Gastric Cancers as well as INN name product Bevacizmabe with the trademark “Avastin” that blocks or slows the growth of new blood vessels, preventing the growth of cancers.

 Petitioners state their medicines Herceptin and Avastin are registered in Sri Lanka and claim that their products are biological drugs and that the product Herticad claims to be a bio similar, but with no proof of similarity.

 They state the Director of Medical Supplies Division for in 2016 called a tender for the supply of “trastuzumab” and 2nd Petitioner A.Baur & Co Ltd submitted a bid. The names of the accepted bidders were read out at a bid reading, the price quoted by the 5th Respondent Pharma Ace Ltd  is the lowest for its drug Herticad which claims to be a similar biotherapeutic product to Herceptin of the Petitioners.

 Petitioners maintain that the Herticad is not a similar biotherapeutic product to Herceptin. They contend that the products Herticad and Avegra manufactured by a private manufacturer in the Russian Federation cannot be registered in Sri Lanka as they do not meet the minimum statutory criteria for registration and the acceptance of the said application constitute a gross illegality.

The petitioners claimed that the irregular and illegal registration of Herticad by NMRA has paved way for the said product to be tested on patients in Sri Lanka when the said drug is not prescribed in any other country.