ONLINE PUBLIC ENGAGEMENT ON PHARMACY BILL

Transcription

1 ONLINE PUBLIC ENGAGEMENT ON PHARMACY BILL Honourable Tun / Tan Sri / Dato 'Sri / Datuk / Dato' / Datin / ladies and gentlemen Assalamualaikum and Salam 1Malaysia, Firstly, I wish to take this opportunity to inform that the Pharmaceutical Services Division, Ministry of Health Malaysia (PSD MOH) proposes the to replace the pre-independence legislations namely the Registration of Pharmacists Act 1951, Poisons Act 1952, Sale of Drugs Act 1952, the Medicines (Advertisement and Sale) Act At present, these legislations have become outdated to meet the current challenges. Lacunae in the existing legislations have posed a major setback to PSD MOH in tackling public complaints on the issue of counterfeited, adulterated and unregistered medicinal product. With a view in safeguarding public interest, PSD MOH is proposing the. Therefore, PSD MOH would like to request feedback from the general public and stakeholders including pharmaceutical and cosmetic industry, pharmaceutical associations and higher education institutions. On behalf of the PSD MOH, I wish to extend my sincere gratitude for your feedbacks. Thank you. Senior Director of Pharmaceutical Services Ministry of Health Malaysia 1

2 PHARMACY BILL 1. Malaysia Pharmacy Act is a transformation of pharmacy legislation. This new act is to replace; Registration of Pharmacists Act 1951 Poisons Act 1952 Sale of Drugs Act 1952 Medicines (Advertisement and Sale) Act Transformations included in the are as follows; Consolidation, harmonisation and liberalisation of the pharmacy legislation. Integration through the establishment of Competent Authority to deal with bureaucracy. The country s obligation to ratify the laws in consistent with international conventions regarding psychotropic and precursor. Lacuna/Loopholes in the pharmacy legislation can be overcome. Deterrent penalties for offences regarding counterfeit medicinal products, adulteration, psychotropic distribution and precursor diversion to protect public interest, safety and health. 3. Chronology Year Phase 1996 Formation of Pharmacy Draft Committee 2003 New Pharmacy Act Workshop: Involvement of all pharmacy sectors, Pharmacy Association, Pharmacy higher learning institutions 2004 Briefing to the MOH Steering Committee 2005 to 2010 Drafting: Direct involvement of MOH Legal Advisor and Attorney General s Office 2010 Dialogue between Enforcement Agencies: Involvement of Medical Practice Division MOH Malaysia, Narcotic Division RMP and Malaysian Customs Briefing to the Director-General of Health Briefing to the Minister of Health Review with Attorney General s Office and the was classified as CONFIDENTIAL document 2

3 4. Power of the Minister of Health o To appoint Pharmacy Council members o To make regulations o To make schedules Medicine Product / Medicine Item classification Prohibited Item Registration and licence fees Controlled Item /Product o To deliberate cases set for appeal o To give exemptions (in consultation with Competent Authority) 5. Establishment of Malaysian Pharmacy Council o Senior Director of Pharmaceutical Services as Chairman o 16 council members consisting by Fully Registered Pharmacists (8 pharmacists in the public service, 3 academicians, 2 pharmacists in the pharmaceutical industry, 3 pharmacists in the private sector (1 from Peninsular Malaysia, 1 from Sabah and 1 from Sarawak) o The functions are: To maintain the registration pharmacists and disciplinary actions To commence registration of pharmacy assistants (involving more than 6000 pharmacy assistants and more than 50% works with MOH) To ensure the quality of pharmacy degree/diploma graduates from all approved higher learning institutions 6. Powers of the Senior Director of Pharmaceutical Services as the Competent Authority The Senior Director of Pharmaceutical Services may delegate power to officers in the Pharmaceutical Services in the execution of provisions in the Act. a. New Control on Medicinal Products Classification and registration of medicinal products on the recommendation of the Medicinal Product Evaluation Committee b. Licensing New registration of all pharmacy premises New licence for Clinical Trials New licence for Industrial Consumers/Professionals 3

4 7. Medicinal Product Evaluation Committee A Pharmacist is appointed as Chairman of the Evaluation Committee by the Competent Authority 21 Pharmacists as permanent members 6 Associate Members o With relevant expertise, medical specialist qualifications or experience o in medicine or pharmaceutical science or veterinary medicine consisting of at least one registered pharmacist in the private sector specializing in the manufacture of products, one toxicology expert and one registered veterinary surgeon Make recommendations to the Competent Authority for the purpose of classification, registration of medicinal products, medicaments and to assess the medicinal product claims before being registered 8. Harmonization of Classification of Products First Schedule Part I Poisons (Group A,B,C,D Poisons ) Part II Poisons Second Schedule Non-poison Third Schedule Psychotropic Substances 3 classification of medicinal products i) Prescription Only Medicines ii) Pharmacist Only Medicinal Products iii) General Sales List Classification of product is as follows; i) Prescription Only Medicines as follows: o Registered psychotropic medicinal products; o Registered narcotic medicinal products; o Registered medicinal products formerly Group B Poisons ii) Pharmacist Only Medicinal Products / Substances as follows: o Psychotropic active substances/precursors formerly Group B/C Poisons o Pharmacist Only Medicinal Products which can be obtained from registered pharmacists without a prescription - formerly Group C Poisons (finished products for dispensing containing antihistamine, pholcodine, antidiabetics, external preparations containing an antibiotic/steroid) iii) General Sales List as follows: o Materials available from the industry/special use for precursor materials, acid and alkaline solvents o Registered products such as traditional medicines or supplements or cosmetics with notification which are available over-the-counter. 4

5 9. Harmonization of Licensing Wholesale/ Manufacturing/ Import Licence issued by the Senior Director of Pharmaceutical Services. Type A,B,C,D,E Licence issued by State Licensing Officer Import/ Poison Wholesale Licence issued by State Licensing Officer the Competent Authority issues licences for Wholesale, Importation, Manufacturing and Clinical Trial of medicinal products power can be delegated to the State Deputy Director of Health (Enforcement Pharmacy) 10. Harmonization of Precursor Control No control on activities of precursor material brokers Prevents the country from becoming a transit point for precursors Broker Licence Special Use in Industry/ Commercial Licence End-User Declaration Benefits to the country as a hub for the pharmaceutical industry growth 11. Liberalisation of Community Pharmacy A pharmacist s License A is in accordance to one premise The establishment of a corporation has to be registered by the Pharmacy Board. A pharmacist may practice in premises listed in his/her Practicing Certificate The pharmacy premise is registered. 5

6 12. Liberalisation of the self regulation of medicinal product and cosmetic advertisements Advertisements requires approval from the Medicine Advertisements Board The guideline for medicine advertisements is not legally binding The guideline for medicine and cosmetic advertisements is legally binding Benefits: Encourages innovation in the promotion of health tourism Advertisement of services and medical devices is not included in this Act Strict liability offence for unregistered products 13. More deterrent penalties RM3000 for poison cases RM10000 for psychotropic cases RM25000 for unregistered products Low penalty issues Have been brought up before in the Parliament Does not concern public safety Does not help to protect the public s interest The NKRA lab suggests deterrent penalties Able to reduce crime rates Does not rectify the requirements of international conventions RM100,000 for unregistered products RM100,000 for Pharmacist Only Products or Prescription Only Medicines Mandatory imprisonment and fine for the following cases: o Counterfeit drugs o Adulterated products o Psychotropic distributions o Precursor diversion Suggestions of penalties: o Individual Minimum imprisonment of 1 year Minimum fine of RM500,000 o Companies Minimum imprisonment of 1 year Minimum fine of RM1,000,000 6

7 14. Reducing bureaucracy by the integration of classification, registration and medicines advertisement processes Via some processes Poison Board meetings for poison classifications Drug Control Authority meetings for product registration Medicine Advertisements Board for advertisement approvals No provision to prohibit the usage of product testing data for registration purposes Integration of the processes involving classification, medicinal product registration and medicinal claims: Via DPS on behalf of a Competent Authority Assessment Committee as secretariat There is a provision to protect a legitimate owner s exclusivity on product testing data 15. Reducing bureaucracy in law amendments by the integration of Directives/Guidelines issued by the Competent Authority Each new amendment is required to go through a few processes before the Parliament s approval The Competent Authority may: Issue a Directive/Guideline which is legally binding after consulting with stakeholders Advise the Minister on amendments of the Fee Schedule, product classification 16. Reducing bureaucracy by integration of Appointment Drug Enforcement Officer processes Appointment of Authority Officer for advertisement by Minister Appointment of Officers and Inspectors by Chief Minister Appointment of Drug Enforcement Officers by Director General of Health Competent Authority appoint Pharmacy Enforcement Officers Police / Custom / Maritime Enforcement Officers and other enforcement officers also appointed as ex-officio for psychotropic and precursor 7

8 17. Consistent legal obligation to ratify the international convention No specific provision for precursor as stated in International Convention 1988 regarding illegal supply of psychotropic and precursor In line with International Conventions, more specific provisions for the control of psychotropic substances and precursors including supplying psychotropic substances and precursor diversion 18. Strengthen Lacuna In the s Difficulty in bring cases of poisons possession ( per se ) Control of Drugs and Cosmetics Regulations 1984 can be interpreted as more restrictive than the principal Act Sale of Drugs Act 1952 Case Sale of Drugs Act 1952 should be brought to court within 60 days There is no provision of "Counterfeit Medicines", "Trafficking of psychotropic", "Drug diversion" and "Data Exclusivity" No power to shut the premises No provision for : Audit accountability Imposing minimum CPD points for renewal of Annual Certification Counterfeit medicine Computerized transaction Sampling for big seizure items Regulations in the previous acts and regulations have been upgraded to be included as a section in the new such as Regulation of drug registration, the registration of pharmacists, psychotropic etc. Provision be introduced in the bill Provision be introduced in the bill 8

9 FEEDBACK FORM ONLINE PUBLIC ENGAGEMENT ON PHARMACY BILL NAME OF INDIVIDUAL / ORGANIZATION OPINION / IMPROVEMENT COMMENTS Facsimile or to: Senior Director of Pharmaceutical Services Ministry of Health Malaysia Address : Lot 36, Jalan Universiti Petaling Jaya Selangor Telephone Number : Facsimile : / 22 ruuf@moh.gov.my 9