NATIONAL NAL REGUL ULATORY ATORY CONFEREN ERENCE CE 2013 7 9 - - PowerPoint PPT Presentation
NATIONAL NAL REGUL ULATORY ATORY CONFEREN ERENCE CE 2013 7 9 MAY 2013 ISTANA HOTEL KUALA LUMPUR Pharmacy Legislative Transformation Mohd Zulkifli Abd Latif Deputy Director PH PHAR ARMACY CY EN ENFORCEM CEMEN ENT T DI DIVI
Mohd Zulkifli Abd Latif Deputy Director
PH PHAR ARMACY CY EN ENFORCEM CEMEN ENT T DI DIVI VISI SION MINIST STRY Y OF HEAL EALTH TH MAL ALAYSI SIA
9 MAY 2013 @ 11.00am -11.45am ISTANA HOTEL KUALA LUMPUR
1. Poisons Act 1952 [Act366] 2. Sale of Drugs Act 1952 [Act368] 3. Medicines (Advertisement and Sale) Act 1956 [Act 290] 4. Registration of Pharmacists Act 1951 [Act 371]
1. None deterrent penalties 2. Do not accommodate current needs 3. Bureaucratic 4. Limitations on Enforcement Activities 5. Limited access to accommodate International Obligations
1. Merging all 4 existing Acts through Consolidation, Harmonisation, and Liberalisation in the Pharmacy Legislations 2. Address lacunae and loopholes in present legislations 3. Deterrent penalties on serious offences 4. May accommodate current needs through directives 5. Reduce bureaucracy (through directives) 6. Wider scope of coverage in Enforcement Activities 7. At all time may accommodate to current International Requirements
1. Poisons Act 1952 [Act366]
Regulating the importation, possession, manufacture, compounding, storage, transport, sale and use of poisons.
2. Sale of Drugs Act 1952 [Act368]
Regulating the sale of drugs.
3. Medicines (Advertisement and Sale) Act 1956 [Act 290]
Control on advertisements relating to medical matters and to regulate the sale of substances recommended as a medicine.
4. Registration of Pharmacists Act 1951 [Act 371]
Establishment of a Pharmacy Board and the registration of pharmacists.
1. None deterrent penalties Highest penalty of fine RM25,000 or 3 years imprisonment or both do not deter
Some offences may harm the public and may also cause death eg. Diversion of psychotropic substances and precursor chemicals & adulteration of poisons in traditional medicines and food & beverages. 2. Do not accommodate current needs Changes in current technologies cannot be applied. The need to put certain changes or requirements in the Act may take a long time as it has to go through Parliament 3. Bureaucratic Most amendments has to go through Parliament or through the Minister. Some decisions has to be made by Boards or Authority that meet less frequent. Certain implementations cannot be done immediately. 4. Limitations on Enforcement Activities Restricted enforcement powers that may easily be challenged in Court like power to audit, detain, seal or closure of premises. No provision on accessibility to computer data Most directives are not legally binding 5. Limited access to accommodate International Obligations Most International requirements are done administratively and do not have legal standing.
1. Merging all 4 existing Acts through Consolidation, Harmonisation, and Liberalisation in the Pharmacy Legislations. 2. Addresses lacunae and loopholes in present legislations. 3. Deterrent penalties on serious offences. 4. May accommodate current needs through directives. 5. Reduce bureaucracy (through directives). 6. Wider scope of coverage in Enforcement Activities. 7. At all time may accommodate to current International Requirements.
7
Classification of Medicines/Medicinal Substances Prohibited Substances Fees for Registrations and licenses Controlled Substances/Products
8
r Dire rector r of Pharm rmaceutical Serv rvices as the Chairm rman of the Pharm rmacy Council.
ting 16 members rs (8 pharm rmacists ts in Public Secto tor, r, 3 academicians, , 2 industri trial pharm rmacists ts, , 3 private pharm rmacists ts [1 Semanjung,1 ,1 Sabah and 1 Sara rawak wak] ] ).
Involving more than 6,000 pharmacy assistants
More than 50% serving MOH Maintain the quality of diploma graduates from 29 private institutions
9
[Senior Director of Pharmaceutical Services as The Competent Authority]
carrying into effect the provisions of the Act.
NEW CONTROL ON MEDICINES
Committee LICENCES Registration on all pharmacy premises
10
anent nt member ers which consist t of fully registere tered d pharma macists ts in the public service. e.
associate te member ers
With th relevant t experti rtise; specialist t qualifi ficati tion or experi rience in medicine, , pharm rmaceuti tical sciences or vete teri rinary ry medicine which consist t of at least t a fully registere red pharm rmacist t in the private te secto tor r specializing in manufa factu turi ring of products ts, a toxicologist t and registe tere red vete teri rinary ry surg rgeon
Present nt Law : First Schedu dule
(Grou
B, C & & D D P Poisons ns )
ns Second nd Schedul ule e
Third d Schedu dule
hotr tropi pic Substan ances es New Pharma macy Law 3 C Classificati tion
nal Produc ucts ts 1. 1. Prescripti tion
ne 2. 2. Pharma macist t Only Medicina nal Produc uct 3. 3. General al Sale List
11
ripti tion Only Medicine: – Registe tere red psychotro tropic medicine – Registe tere red Narcoti tic Medicine – Registe tere red Medicine (Group B Poison under r the present t Poisons Act t 1952)
tance/Ph Pharm rmacy Only Medicinal Product Acti tive Substa tance of Psychotro tropic/Pre /Precurs rsors rs (Pre reviously Group B or C) C) Pharm rmacy Only Medicinal Product t – available from a registe tere red pharm rmacist t with thout t a prescri ripti tion - (Pre reviously Group C) C) ( finished product t to be dispensed conta taining anti tihista tamine, , pholcodeine, , anti tidiabeti tic, , exte tern rnal prepara rations containing anti tibioti tic/s /ste tero roid )
ral Sale List :- – Industri trial usage for precurs rsor r substa tance, acid and alkali solvents ts – Registe tere red products like traditi tional prepara rati tions, supplements ts or noti tifi fied cosmeti tic s available over-th the-counte ter.
12
Licens nses es for wholesale / manufactur acture/i /imp mport
ed by PKPF PKPF Type e A,B,C,D, D,E Licens nses es issue ued d by State Licens nsing ng Officer er
New Pharmacy
Wholesale, , Import, rt, Manufacture re and Clinical Trial for r Medicinal Products. .
r can be delegate ted to the respecti tive State te Deputy ty Directo tor r of Health th (Pharm rmacy)
13
No contro rol on the brokers rs of precurs rsor r substa tances Prevent the Country try as transit t point t for precurs rsors rs
r license
r License for Industri tries/Com /Commerc rcial
r Declara rati tion
try as hub for r development of pharm rmaceuti tical industry try)
14
O N O H H N ( Formic acid ) Methylamine, Aluminum, Mercuric chloride H N OH Hydriodic acid, Red phosphorus Leuckart method Reductive amination Nagai method Perchloric acid, Hydrogen gas, Palladium-Bariumsulfate Rosenmund method H N Cl Thionyl chloride Hydrogen gas, Palladium-Bariumsulfate Emde method Methamphetamine BMK (P-2-P) Ephedrine Lithium (or Natrium) in Liquid ammonia Chloroephedrine Cl O OH H Benzylchloride N Benzylcyanide Phenylacetic acid O Benzaldehyde AA (acetic anhydride), Natrium acetate anhydride Methylformamide Hydrochloric acid N-formylmethamphetamine Birch reduction
Interrelationship
Interrelationship of methamphetamine and main precursor substances
Malayan Tiger Tiger Woods
e A L License nse is tied up with one premi mises es.
porate te to be registered tered by Pharma macy Board
ticing Certi tifi ficate te allows ws a pharm rmacist t to practi tice at severa ral premises
rmacy premises are registere red
18
tisem ement nt to be approved
by Medicine ne Advert ertiseme ment t Board d (MAB/LI LIU) U)
tisem ement nt Guidelines es are not legally binding New Pharmacy
Adverti
ertisem emen ent Guideline nes are legally binding Advant ntag age: e:- Promote te Health Tourism Strict liability offence e for unregi gistered ered produc uct Adverti tisem ement nt on services es and medical al devices es are no longer control
d by the Act
19
products
penalties
ment
deterrent penalties
me rate
international convention
atory imprisonm nment ent and higher her fines es for cases es:-
nterfei feit t medicines es, ,
terate ated d produc ucts ts, ,
fficking ng and diver ersion
psychotr hotropi
precurs ursor
Eg
alty ty upon convicti tion
traffi fficking ng of psychotro hotropi pic substanc tances es:- “Imprisonment for a term not not less than six years and and not not exceeding twenty years “
24
Methamphetamine clandestine laboratory in Kulim using Precursor Chemicals
Cland lab (Sri Hartamas)
Thro rough severa ral processes
classification of poisons
for products registration
Board meeting for approval of advertisements New Pharmacy
Inte tegra rati tion Process of Substa tance Classifi ficati tion, , Registra trati tion of Products ts and Adverti rtisement t of Medicines
Pharmaceutical Services as Competent Authority
secretariat
30
– Each new amendment would undergo several processes for approval in Parliament
The Compete
tent t Auth thori rity may: issue instructions or guidelines that are "Legally binding“ advise the Minister to amend the fee schedule, product classification
31
tment t of auth thori rised
ficer r by the Ministe ter r for cases
rtisements ts
tment t of inspecto tors rs by Chief f Ministe ter r for Product t cases
tment t of enfo forc rcement t
ficers rs by Dire rector r Genera ral of Health th
tent t Auth thori rity ty appoints ts enfo forc rcement t offi ficers rs
appointed as ex-officio in the case of psychotropic substances and precursors
32
– There are no specific provisions for precursors as 1988 Convention on illicit traffic of psychotropic substances and precursors
– more specific provisions, In line with international conventions, for control of psychotropic substances and precursors, including trafficking in psychotropic substances and precursor diversion
33
– Cannot t prosec ecut ute e cases es for possess ession n of poison(“possession per se”) – Control of Drugs gs and Cosmet etics Regulati tion
can be interpre prete ted d as more e restrict trictive e than the parent nt act i.e. Sale of Drugs Act 1952 – Case s under Sale of D Drugs gs Act 1952 should be charged ed at court t within 60 d days – No provision for “Counterfeit medicines”, “Trafficking of psychotropic”, “Drug diversion”, “Data Exclusivity” – No power to shut premi mises es
New Pharm
tions
upgrade aded d to be incorporat porated ed as sections ns in t the Pharmac acy Bill (Eg. Regulation of drug registration, the registration of pharmacists, psychotropic etc.)
de provisions ns in t the New Law
34
No provisions ns for:
tabi bility ty
ng minimum m CPD points for renewa wal of annual certi tifi ficate ate
terized ed trans nsac action n record
g for huge seizures ures
ded d in the New Law
35
36