An Empirical Review of Major Legislation Affecting Drug Development (Kesselheim 2011)
Legislation Development In Tobaccocontrol
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Transcript of Legislation Development In Tobaccocontrol
Comprehensive Tobacco Comprehensive Tobacco Comprehensive Tobacco Comprehensive Tobacco Control LegislationControl LegislationControl LegislationControl Legislation
: key features : : key features : : key features : : key features : characteristics characteristics characteristics characteristics ---- structuresstructuresstructuresstructures
Position of Tobacco in Position of Tobacco in Position of Tobacco in Position of Tobacco in Constitutional Scheme of Constitutional Scheme of Constitutional Scheme of Constitutional Scheme of
thingsthingsthingsthingsQuestion: Is there a right to consume tobacco
Considerthefact:
� Istobaccoafood?
� Istobaccoausefuldrug?
� Istobaccoanutritiousconcoction?
� Istobaccoinanywayusefultoahumanbeing
� Istobaccoaneutralconsumerproduct?
� Whyisitmarketed/sold/traded?
So can someone claim it as a right to consume tobacco –Technically NO
Question: Would restricting use of tobacco violate right of life or liberty or even trading?
Courts have held otherwise – There is no constitutional/fundamental right to consume tobacco –restricting tobacco does not violates anyone’s right
Key Ingredients of a Key Ingredients of a Key Ingredients of a Key Ingredients of a ““““Good LawGood LawGood LawGood Law””””
1. ProperlyDraftedlegislation
2. Balancebetweenprimarylegislationand
delegatedlegislation
3. GoodCONNECTbetweenthelegislation,the
ConstitutionandotherLaws
4. Easeandclarityofenforcementofthelegislation
5. SimpleandFastProcedureofProsecution
Challenges in Tobacco Challenges in Tobacco Challenges in Tobacco Challenges in Tobacco Control LegislationsControl LegislationsControl LegislationsControl Legislations
�Interferenceby“TobaccoIndustry”
�CampaignofMisinformation&Misguidance
�PerceptionofTobaccoasa“EconomicContributor”
byasectionofgovernment
�Dilutionoflegislationatdraftingstageitself(The
standardtobaccoindustrystrategy)
�LowPriorityLegislation
�LackofCapacity
Example of challenges withinExample of challenges withinExample of challenges withinExample of challenges within
DEPARTMENTOFCOMMERCE
RAJYA�SABHA
STARRED�QUESTION�NO�390�
ANSWERED�ON�23.08.2006�
UNFAIR�TREATMENT�TO�VIRGINIA�TOBACCO�AT�WTO�NEGOTIATIONS .
390.�SHRI�V.�HANUMANTHA�RAO�Will�the�Minister�of�COMMERCE�AND�INDUSTRY�be�pleased�to�state:-
(a)�whether�Government�have�noted�that�cash�crops�like�Virginia�tobacco�are�not�receiving�fair�treatment�during�WTO�negotiations;�
(b)�whether�it�is�also�a�fact�that�Free�Trade�Agreements�between India�and�neighbouring�countries�is�harming�Indian�tobacco�farmers’ interest;�
(c)�in�what�way�will�Government�bring�about�equity�and�fairness�in�international�trade�policies�to�help�farmers�of�Andhra�Pradesh�and�Karnataka;�and�
(d)�the�steps�proposed�to�reduce�such�aspects�of�FTAs which�harm�Indian�farmers?�
ANSWER
MINISTER�OF�COMMERCE�AND�INDUSTRY�
(�SHRI�KAMAL�NATH�)�
(a):�In�the�WTO�negotiations,�steps�are�being�taken�to�address�the�structural�distortions�in�agricultural�trade�caused�due�to�subsidization�and�protection�of�agricultural�products,�including�cash�crops�like�Virginia�tobacco.�
(b)�to�(d):�Under�India’s�Regional�Trade�Arrangements�(RTAs),�tariff�concessions�on�imports�into�India,�with�duty�free�access�subject�to�fulfillment of�value�addition�criteria,�on�tobacco�have�been�offered�only�under�the�Indo-Sri�Lanka�Free�Trade�Agreement�(FTA).�Sri�Lanka�has�retained�tobacco�in�its�negative�list�of�imports.�The�Government�has�requested�Sri�Lanka�to�provide�parity�with�India’s�tariff�concessions�on�tobacco.�Matters�relating�to�exports�to�India�by�Sri�Lanka�of�cigarettes�manufactured�with�imported�tobacco�have�also�already�been�raised�by�the�Government�with�Sri�Lanka�under�the�review of�the�Indo-Sri�Lanka�FTA.�
…………………..etc�……………………….
Key Ingredients Key Ingredients Key Ingredients Key Ingredients –––– Well Well Well Well Defined ObjectivesDefined ObjectivesDefined ObjectivesDefined Objectives
IMPORTANCE OF THE PREAMBLE:-Principles and Purpose
Most laws contain a general statement of the purpose and/or principles of
the law.
The purpose of a law provides the framework within which the law will be
implemented and interpreted.
In the context of a legal challenge to a law or its regulations, this
framework can play a critical role. Therefore, words should be carefully
chosen and should clearly and accurately reflect the scope of issues that
the government intends to regulate.
Good Example: FCTC – TC Legislation of India
From the FCTC PreambleFrom the FCTC PreambleFrom the FCTC PreambleFrom the FCTC Preamble
Preamble of FCTCPreamble of FCTCPreamble of FCTCPreamble of FCTCThePartiestothisConvention,
Determinedtogiveprioritytotheirrighttoprotectpublichealth,
Recognizing thatthespreadofthetobaccoepidemicisaglobalproblemwithseriousconsequencesforpublichealththatcallsforthewidest possibleinternationalcooperationandtheparticipationofallcountries inaneffective,appropriateandcomprehensiveinternationalresponse,
Reflecting theconcernoftheinternationalcommunityaboutthedevastatingworldwidehealth,social,economicandenvironmentalconsequencesoftobaccoconsumptionandexposuretotobaccosmoke,
Seriously concernedabouttheincreaseintheworldwideconsumptionandproductionofcigarettesandothertobaccoproducts,particularlyindevelopingcountries,aswellasabouttheburdenthisplacesonfamilies,onthepoor,andonnationalhealthsystems,
…………….etc…………….
The elements of comprehensive The elements of comprehensive The elements of comprehensive The elements of comprehensive TC legislationTC legislationTC legislationTC legislation
� Institutions�and�mechanisms. Legislationshouldcreate,empowerandfundanauthoritytoimplementanddirectthelegislation.
� Public�education. Largepubliceducationcampaignsareimportantpartsofchangingpublicattitudesandbeliefs.
� Advertising,�promotion�and�sponsorship. Acomprehensivebanontobaccoadvertising,promotionandsponsorshipisacentrepieceofaneffectivetobaccocontrolprogramme.
� Taxes. Taxincreaseshavebeenproventobeoneofthemosteffectivemeansofreducingtobaccoconsumption,especiallyamongyoungpeople.
� Second-hand�smoke. Eliminatingsmokinginworkplacesandpublicplacesprotectsnon-smokersfromthehazardsofexposuretosmoke,discouragessmokinginitiationandpromotescessation.
The elements of comprehensive The elements of comprehensive The elements of comprehensive The elements of comprehensive TC legislationTC legislationTC legislationTC legislation
� Labelling�and�packaging. Large,clearhealthwarningsandinformationalmessages,usingrotatingmessagesdevelopedbynationalauthorities,shouldberequiredontobaccopackaging,andtobaccoproductsshouldnotbepromotedusingmisleadingterms.
� Product�regulation. Regulatoryauthorityshouldbegiventoaspecializedagency,toaddresssuchissuesasingredientdisclosure,permissibilityofharmfulconstituents,additivesafety,andtarandnicotineyields.
� Tobacco�sales. Legislationshouldprohibitthesaleoftobaccotoandbytheminors.
� Smuggling. Tocombatillicittrade,comprehensivelegislationshouldincludemeasuressuchasrequirementsforpackagemarkingsorcreationofaregimefortrackingandtracingproductsthroughthedistributionchain.
� Other�issues. Comprehensivelegislationmayalsoincludeprovisionstoaddresssmokingcessation,createschool-basedprogrammes,modifyagriculturalpoliciesoraddressissuesoflegalliability.
Key Ingredients Key Ingredients Key Ingredients Key Ingredients ---- ClarityClarityClarityClarity
� MinimizingAmbiguity–
Example�(Bad): DefinitionofPublicPlacesinIndia
Section2(l)“publicplace” meansanyplacetowhichthepublic
haveaccess,whetherasofrightornot,andincludesauditorium,
hospitalbuildings,railwaywaitingroom,amusementcentres,
restaurants,publicoffices,courtbuildings,educational
institutions,libraries,publicconveyancesandthelikewhichare
visitedbygeneralpublicbutdoesnotincludeanyopenspace;
Rule2(c)“openspace” mentionedinSection3(1)oftheActshall
notincludeanyplacesvisitedbythepublicsuchasopen
auditorium,stadium,railwaystation,busstopandsuchother
places;
Key Ingredients Key Ingredients Key Ingredients Key Ingredients ---- ClarityClarityClarityClarity
� Clarityindescriptionofviolations
� Properandwelldefinedactionforeachviolation
– BADExample:Section22.�Whoevercontravenestheprovisionofsection5shall,onconviction,bepunishable—
(a)inthecaseoffirstconviction,withimprisonmentforatermwhichmayextendtotwoyearsorwithfinewhichmayextendtoonethousandrupeesorwithboth,and
(b)inthecaseofsecondorsubsequentconvictionwithimprisonmentforatermwhichmayextendtofiveyearsandwithfinewhichmayextendtofivethousandrupees.
� Clearguidelinesw.r.t.sequenceoflegalprocedurestobefollowed
SYSTEM�OF�INCORPORATING�DELEGATED�LEGISLATION�WITH�SAME�KIND�OF�OBJECTIVITY
Key Ingredients Key Ingredients Key Ingredients Key Ingredients ---- SimplicitySimplicitySimplicitySimplicity
KISSKeep It Short & Simple
Key Ingredients Key Ingredients Key Ingredients Key Ingredients ---- SimplicitySimplicitySimplicitySimplicity
Less�is�More
Simplestructuresandstandardsusuallyleadto
fewerproblemsthanelaborateschemesorrules
riddledwithexceptionsandqualifications.
Example: Peoplewhoshouldenforcethelaw– All
Gazetted officers,etc.---- Leadstoconfusion----
couldbemoreclearerlike…..Thedepartmental
heads
Key Ingredients Key Ingredients Key Ingredients Key Ingredients ---- ConsistencyConsistencyConsistencyConsistency
Thelawmusthaveacoherentinternalstructurethatholds
togetherwithoutomissionsorgapsoflogic.Itshouldalso
beconsistentwithexistinglaws,sothetobaccocontrol
programmewillblendwithotherprogrammes.Forexample,
definitionsshouldresemblethedefinitionsofsimilarterms
inexistinglaws,unlesstherearegoodreasonsfora
differentapproach.
Example:- TobaccoControlLawinacountryhasalmost
20differentsetofrulesandtheychangetoofrequently……
eventhedefinitionsof“PublicPlaces” changeeverysix
month…..Notagoodthing
Key Ingredients Key Ingredients Key Ingredients Key Ingredients ---- FamiliarityFamiliarityFamiliarityFamiliarity
Itisusuallyadvantageoustousefamiliarconceptsand
mechanisms.Forexample,selectingwell-established
enforcementproceduresalreadyusedbyotherlaws,rather
thandesigningcompletelynewones,islikelytominimize
theriskofunexpectedproblemsinimplementation,and
maybemorereadilyacceptedbythelegislativebody.
Example: Systemofpenalizingandprosecution,asincase
oftrafficviolations,isalreadyestablished.Usingasimilar
mechanismwouldbeeasilyaccepted.
Key Ingredients Key Ingredients Key Ingredients Key Ingredients ---- FlexibilityFlexibilityFlexibilityFlexibility
Tobaccocontrollegislationshouldbeflexible.Overtime,
changeswillbeneededastheimpactofthelegislationis
evaluated,asnewscientificevidenceemerges,as
technologiesimprove,andasnewinterventionsare
designed.Legislationshouldbewrittentogiveregulatory
authoritieslatitudetoadapttotheseconditions.
It�is�not�advisable�to�have�water-tight�legislation�–
Whereas,�at�the�same�time�care�must�be�taken�that�
someone�is�not�able�to�dilute�the�basic�legislation�by�it�
being�too�lax
Key Ingredients Key Ingredients Key Ingredients Key Ingredients –––– FlexibilityFlexibilityFlexibilityFlexibilityExpansion of scope with primary objectivesExpansion of scope with primary objectivesExpansion of scope with primary objectivesExpansion of scope with primary objectives
The areas where there is a scope to use delegated legislation (Rules, Regulation and Notifications for Executive Control) should be
clearly identified, so that the law is able to adapt (But not misused) as:
– theimpactofthelegislationisevaluatedandneedforchangeis
realised
– asnewscientificevidenceemerges
– astechnologiesimprove
– asnewinterventionsaredesigned
Good�Example: Thailand’s1992TobaccoControlLaw
Things to take care ofThings to take care ofThings to take care ofThings to take care of
– Ensurenoconflictswithotherlaws
– Takingcareofthedefinitions– Shouldbeinunison
Like
PublicPlaces
ManufacturerandTrader
Cigarette
Example: Section278�of�Indian�Penal�Code�1860
Makingatmospherenoxioustohealth:- Whoevervoluntarilyvitiates
theatmosphere inanyplacesoastomakeitnoxious tothehealthof
personsingeneraldwelling orcarryingonbusinessinthe
neighbourhood orpassingalongapublicway,shallbepunishedwith
finewhichmayextendtofivehundredrupees.
Things to take care ofThings to take care ofThings to take care ofThings to take care of
Known loopholes- Negative+Negative
- Inclusionclauseindefinitionsofprovisionssoasthatitappearstobeexhaustive:Example– DefinitionofPublicPlaces
- Proviso’sandExemptionClauses
- Requirementunderthelawismentionedbutpenalconsequencesforviolationsaremissing
- Requiringspecificconditions,usuallydifficulttomonitor
How�to�avoid�them
Example:
Indian�Law: Restaurantswithseatingcapacityof30
Thailand: NonACrestaurants
Exemptionclausedifficulttomonitor
Definition of Cigarette in 1975 Definition of Cigarette in 1975 Definition of Cigarette in 1975 Definition of Cigarette in 1975 Indian ActIndian ActIndian ActIndian Act
The EnforcementThe EnforcementThe EnforcementThe Enforcement
Key to success of any Key to success of any Key to success of any Key to success of any legislation depends on itlegislation depends on itlegislation depends on itlegislation depends on it’’’’s s s s
effectiveeffectiveeffectiveeffective
ENFORCEMENTENFORCEMENTENFORCEMENTENFORCEMENT�Thesameistruefor“TobaccoControl” lawstoo
�Unfortunatelyenforcementcomponentgetsvery
littleattentionandnotmuchworkhasbeendone
onenforcementoftobaccocontrollaws