IN THE COURT OF APPEAL OF THE DEMOCRATIC SOCIALIST REPUBLIC OF SRI LANKA In an application under an in terms of Article 140 of the Constitution for mandates in the nature of writs of certiorari and prohibition.

Case No. Writ Application No: C.A. (Writ) 793/2023

1. Sri Lanka Chamber of the Pharmaceutical Industry C/o The Ceylon Chamber of Commerce, No.50, Nawam Mawatha, Colombo 02.

2. PrathabanMylvaganam, President, Sri Lanka Chamber of the Pharmaceutical Industry, C/o The Ceylon Chamber of Commerce, No.50, Nawam Mawatha, Colombo 02.

3. Azam Mohamed Jaward, Senior Vice President, Sri Lanka Chamber of the Pharmaceutical Industry, C/o The Ceylon Chamber of Commerce, No.50, Nawam Mawatha, Colombo 02.

4. Bogahawattegedara Nandana Shantha Bandara, Vice President, Sri Lanka Chamber of the Pharmaceutical Industry, C/o The Ceylon Chamber of Commerce, No.50, Nawam Mawatha, Colombo 02.

PETITIONERS Vs.

1. Hon. Dr. Ramesh Pathirana Minister of Health, Ministry of Health, Suwasiripaya, No.385, Ven.

BaddegamaWimalawansa Thero Mawatha, Colombo 10.

2. The Secretary Ministry of Health, Suwasiripaya, No.385, Ven.

BaddegamaWimalawansa Thero Mawatha, Colombo 10.

3. SirimalAbayaratne Chairman

4. Dr. Ananda Wijewickrema Member

5. Indrajith Aponsu Member

6. Prof. Chandrasiri Abyessinghe Member

7. Prof. Ruwan Jayathilake Member

8. Dr. Mahanama Gunasekara Member

9. AchinthaHewanayake Member

10. W.M. Niluka Weerasekara Member The 3rd to 10th Respondents all at, The Pricing Committee, The National Medicines Regulatory Authority, No.120, Norris Canal Road, Colombo 10.

11. The National Medicines Regulatory Authority, No.120, Norris Canal Road, Colombo 10.

RESPONDENTS Before: Hon. D.N. Samarakoon, J.

Hon. Neil IddawalaJ.

Counsel: Dr. Romesh De Silva, P.C., for the Petitioner.

Mr. Sumathi Dharmawardena, A.S.G., P.C., for the Respondents.

Supported on :14.12.2023 Written submission tendered on: Not tendered by any party Decided on:22.12.2023 D.N. Samarakoon, J This matter was supported in Open Court from 10.55 a.m. by the learned President’s Counsel appearing for the petitioners. The Court also heard submissions made by the learned Additional Solicitor General, President’s Counsel for all the respondents, who appeared in Court on direct notice given by the petitioners too from 11.40 a.m. The learned President’s Counsel for the petitioners were heard in reply from 12.05 p.m. and both counsel briefly clarified certain positions thereafter.

The petitioners are “Sri Lanka Chamber of the Pharmaceutical Industry” and three others. The respondents are “Minister of Health” and ten others, the 03rd to 10th being “The Pricing Committee” of “The National Medicines Regulatory Authority” and the 11th respondent “The National Medicines Regulatory Authority”.

The 01st petitioner, according to the petition, is constituted by importers, manufacturers, distributors, wholesalers and retailers of pharmaceuticals and medicinal devices and the majority of the business enterprises, which are engaged in the pharmaceutical business.

The learned President’s Counsel for the petitioners drew the attention of the Court to section 118 of National Medicines Regulatory Authority Act, which is the first section in Part III “Pricing of Medicines, Medical Devices and Borderline Products”. It says, “118. Pricing of medicines.

(1) –

(a) The Authority shall appoint a Committee to be known as the Pricing Committee.

(b) The composition, powers and functions of the Pricing Committee shall be as prescribed.

(2) –

(a) The Authority shall in consultation with the Pricing Committee, determine the introductory price of medicines, medical devices and borderline products at the time of registration, based on the criteria as may be prescribed.

(b) For the purpose of paragraph (a) the Authority shall consider the prevailing market prices of similar products within the same therapeutic class, International Reference Prices and other factors as may be prescribed.

(3) For the purpose of determining the prices of New Chemical Entities, the Auth