Statement of Principles concerning diabetes mellitus (Balance of Probabilities) (No. 49 of 2020)

made under subsection 196B(3) of the

Veterans' Entitlements Act 1986

Compilation No. 2               

Compilation date:                              30 May 2022

Includes amendments up to:           Amendment Statement of Principles concerning diabetes mellitus (Balance of Probabilities) (No. 50 of 2022) (F2022L00666)

The day of commencement of this Amendment Statement of Principles concerning diabetes mellitus is 30 May 2022.

 

About this compilation

 

This compilation

This is a compilation of the Statement of Principles concerning diabetes mellitus (Balance of Probabilities) (No. 49 of 2020) that shows the text of the law as amended and in force on 30 May 2022.

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

 

 

  

  

  

Contents

1......... Name................................................................................................................................................. 2

3......... Authority........................................................................................................................................... 2

5......... Application....................................................................................................................................... 2

6......... Definitions........................................................................................................................................ 2

7......... Kind of injury, disease or death to which this Statement of Principles relates..................... 2

8......... Basis for determining the factors................................................................................................. 3

9......... Factors that must exist................................................................................................................... 3

10....... Relationship to service................................................................................................................... 8

11....... Factors referring to an injury or disease covered by another Statement of Principles....... 8

Schedule 1 - Dictionary.................................................................................................. 9

1......... Definitions........................................................................................................................................ 9

Endnotes.................................................................................................................................. 14

Endnote 1—About the endnotes............................................................................................................ 14

Endnote 2—Abbreviation key................................................................................................................ 15

Endnote 3—Legislation history.............................................................................................................. 16

Endnote 4—Amendment history........................................................................................................... 17

 

 

1             Name

This is the Statement of Principles concerning diabetes mellitus (Balance of Probabilities) (No. 49 of 2020).

3             Authority

This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986.

5             Application

This instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004 applies.

6             Definitions

The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument.

7             Kind of injury, disease or death to which this Statement of Principles relates

(1)          This Statement of Principles is about diabetes mellitus and death from diabetes mellitus.

Meaning of diabetes mellitus

(2)          For the purposes of this Statement of Principles, diabetes mellitus:

(a)           means persistent hyperglycaemia characterised by either:

(i)            two positive laboratory blood tests on separate days showing:

A.           a fasting plasma glucose concentration of at least 7.0 millimoles per litre; or

B.            a plasma glucose concentration of at least 11.1 millimoles per litre two hours after ingestion of 75 grams of glucose on a baseline fasting state (glucose tolerance test); or

C.            an HbA_1c level of at least 6.5%; or

(ii)          an episode of diabetic ketoacidosis or hyperosmolar hyperglycaemic state with a blood glucose level of at least 11.1 millimoles per litre; and

(b)          includes:

(i)            drug-induced diabetes mellitus;

(ii)          gestational diabetes mellitus;

(iii)        primary diabetes mellitus;

(iv)        secondary diabetes mellitus;

(v)          type 1 diabetes mellitus; and

(vi)        type 2 diabetes mellitus; and

Note: type 1 diabetes mellitus and type 2 diabetes mellitus are defined in the Schedule 1 – Dictionary.

(c)           excludes impaired glucose tolerance.

(3)          While diabetes mellitus attracts ICD‑10‑AM code E10, E11, E12, E13 or E14, in applying this Statement of Principles the meaning of diabetes mellitus is that given in subsection (2).

(4)          For subsection (3), a reference to an ICD-10-AM code is a reference to the code assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM), Tenth Edition, effective date of 1 July 2017, copyrighted by the Independent Hospital Pricing Authority, ISBN 978-1-76007-296-4.

Death from diabetes mellitus

(5)          For the purposes of this Statement of Principles, diabetes mellitus, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's diabetes mellitus.

Note: terminal event is defined in the Schedule 1 – Dictionary.

8             Basis for determining the factors

On the sound medical‑scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that diabetes mellitus and death from diabetes mellitus can be related to relevant service rendered by veterans or members of the Forces under the VEA, or members under the MRCA.

Note: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary.

9             Factors that must exist

At least one of the following factors must exist before it can be said that, on the balance of probabilities, diabetes mellitus or death from diabetes mellitus is connected with the circumstances of a person's relevant service:

(1)          having an endocrine disorder from the specified list of endocrine disorders before the clinical onset of diabetes mellitus;

Note: specified list of endocrine disorders is defined in the Schedule 1 - Dictionary.          

(2)          having a solid organ transplant or bone marrow transplant before the clinical onset of diabetes mellitus;

(3)          having glucocorticoid therapy as specified, before the clinical onset of diabetes mellitus, and where the glucocorticoid therapy as specified has ceased or decreased, the last dose of the therapy was received within the 30 days before the clinical onset of diabetes mellitus;

Note: glucocorticoid therapy as specified is defined in the Schedule 1 - Dictionary.           

(4)          being treated with a drug from the Specified List 1 of drugs, which cannot be ceased or substituted, for at least the seven days before the clinical onset of diabetes mellitus;

Note: Specified List 1 of drugs is defined in the Schedule 1 - Dictionary.            

(5)          being treated with a drug from the antidepressant or antipsychotic classes of drugs, which cannot be ceased or substituted, for at least the three months before the clinical onset of diabetes mellitus;

(6)          for type 1 diabetes mellitus only:

(a)           undergoing surgery to the pancreas before the clinical onset of diabetes mellitus;

(b)          having a specified pathological condition involving the pancreas before the clinical onset of diabetes mellitus;

Note: specified pathological condition involving the pancreas is defined in the Schedule 1 - Dictionary.             

(c)           having haemolytic uraemic syndrome before the clinical onset of diabetes mellitus;

Note: haemolytic uraemic syndrome is defined in the Schedule 1 - Dictionary.      

(d)          ingesting N-3-pyridyl methyl-N'-p-nitrophenyl urea (Vacor) within the 30 days before the clinical onset of diabetes mellitus; or

(e)           taking an immune checkpoint inhibitor or an interferon within the one year before the clinical onset of diabetes mellitus;

Note: immune checkpoint inhibitor is defined in the Schedule 1 - Dictionary

(7)          for type 2 diabetes mellitus only:

(a)           having smoked at least five pack-years of tobacco products before the clinical onset of diabetes mellitus, and where smoking has permanently ceased, the clinical onset of diabetes mellitus has occurred within 15 years of cessation;

Note: pack-year of tobacco products is defined in the Schedule 1 - Dictionary.

(b)          being exposed to second-hand smoke for at least 5,000 hours before the clinical onset of diabetes mellitus, and where exposure to second-hand smoke has permanently ceased, the clinical onset of diabetes mellitus has occurred within 15 years of cessation;

Note: being exposed to second-hand smoke is defined in the Schedule 1 - Dictionary.

(c)           being overweight or obese for at least five years before the clinical onset of diabetes mellitus;

Note: being overweight or obese is defined in the Schedule 1 - Dictionary.

(d)          an inability to undertake moderate physical activity of at least four METs for at least the five years before the clinical onset of diabetes mellitus;

Note: MET is defined in the Schedule 1 - Dictionary.

(e)           having cirrhosis of the liver at the time of the clinical onset of diabetes mellitus;

(f)           having non-alcoholic steatohepatitis at the time of the clinical onset of diabetes mellitus;

(g)          having infection with human immunodeficiency virus before the clinical onset of diabetes mellitus;

(h)          having infection with hepatitis C virus before the clinical onset of diabetes mellitus;

(i)            having depressive disorder at the time of the clinical onset of diabetes mellitus;

(j)            having bipolar disorder at the time of the clinical onset of diabetes mellitus;

(k)          having schizophrenia at the time of the clinical onset of diabetes mellitus;

(l)            having bilateral orchiectomy before the clinical onset of diabetes mellitus;

(m)        having anti-androgen therapy with a gonadotrophin releasing hormone agonist, including goserelin and leuprorelin, for at least the one year before the clinical onset of diabetes mellitus; or

(n)          being exposed to arsenic as specified before the clinical onset of diabetes mellitus;

Note: being exposed to arsenic as specified is defined in the Schedule 1 - Dictionary.

(8)          for gestational diabetes mellitus and type 2 diabetes mellitus only, being pregnant at the time of the clinical onset of diabetes mellitus;

(9)          having an endocrine disorder from the specified list of endocrine disorders before the clinical worsening of diabetes mellitus;

Note: specified list of endocrine disorders is defined in the Schedule 1 - Dictionary.          

(10)      having a solid organ transplant or bone marrow transplant before the clinical worsening of diabetes mellitus;

(11)      having glucocorticoid therapy as specified, before the clinical worsening of diabetes mellitus, and where the glucocorticoid therapy as specified has ceased or decreased, the last dose of the therapy was received within the 30 days before the clinical worsening of diabetes mellitus;

Note: glucocorticoid therapy as specified is defined in the Schedule 1 - Dictionary.           

(12)      being treated with a drug from the Specified List 1 of drugs, which cannot be ceased or substituted, for at least the seven days before the clinical worsening of diabetes mellitus;

Note: Specified List 1 of drugs is defined in the Schedule 1 - Dictionary.            

(13)      being treated with a drug from the antidepressant or antipsychotic classes of drugs, which cannot be ceased or substituted, for at least the three months before the clinical worsening of diabetes mellitus;

(13a) taking an immune checkpoint inhibitor or an interferon within the one year before the clinical worsening of diabetes mellitus;

Note: immune checkpoint inhibitor is defined in the Schedule 1 - Dictionary.

(14)      undergoing surgery to the pancreas before the clinical worsening of diabetes mellitus;

(15)      having a specified pathological condition involving the pancreas before the clinical worsening of diabetes mellitus;

Note: specified pathological condition involving the pancreas is defined in the Schedule 1 - Dictionary.

(16)      having haemolytic uraemic syndrome before the clinical worsening of diabetes mellitus;

Note: haemolytic uraemic syndrome is defined in the Schedule 1 - Dictionary.   

(17)      ingesting N-3-pyridyl methyl-N'-p-nitrophenyl urea (Vacor) within the 30 days before the clinical worsening of diabetes mellitus;

(18)      having depressive disorder at the time of the clinical worsening of diabetes mellitus;

(19)      having bipolar disorder at the time of the clinical worsening of diabetes mellitus;

(20)      having schizophrenia at the time of the clinical worsening of diabetes mellitus;

(21)      for type 2 diabetes mellitus only:

(a)           having smoked at least five pack-years of tobacco products before the clinical worsening of diabetes mellitus, and where smoking has permanently ceased, the clinical worsening of diabetes mellitus has occurred within 15 years of cessation;

Note: pack-year of tobacco products is defined in the Schedule 1 - Dictionary.

(b)          being exposed to second-hand smoke for at least 5,000 hours before the clinical worsening of diabetes mellitus, and where exposure to second-hand smoke has permanently ceased, the clinical worsening of diabetes mellitus has occurred within 15 years of cessation;

Note: being exposed to second-hand smoke is defined in the Schedule 1 - Dictionary.

(c)           being overweight or obese for at least five years before the clinical worsening of diabetes mellitus;

Note: being overweight or obese is defined in the Schedule 1 - Dictionary.

(d)          an inability to undertake moderate physical activity of at least four METs for at least the five years before the clinical worsening of diabetes mellitus;

Note: MET is defined in the Schedule 1 - Dictionary.

(e)           having cirrhosis of the liver at the time of the clinical worsening of diabetes mellitus;

(f)           having non-alcoholic steatohepatitis at the time of the clinical worsening of diabetes mellitus;

(g)          having infection with human immunodeficiency virus before the clinical worsening of diabetes mellitus;

(h)          having infection with hepatitis C virus before the clinical worsening of diabetes mellitus;

(i)            having bilateral orchiectomy before the clinical worsening of diabetes mellitus;

(j)            having anti-androgen therapy with a gonadotrophin releasing hormone agonist, including goserelin and leuprorelin, for at least the one year before the clinical worsening of diabetes mellitus; or

(k)          being exposed to arsenic as specified before the clinical worsening of diabetes mellitus;

Note: being exposed to arsenic as specified is defined in the Schedule 1 - Dictionary.

(22)      for gestational diabetes mellitus and type 2 diabetes mellitus only, being pregnant at the time of the clinical worsening of diabetes mellitus;

(23)      inability to obtain appropriate clinical management for diabetes mellitus.

10           Relationship to service

(1)          The existence in a person of any factor referred to in section 9, must be related to the relevant service rendered by the person.

(2)          The factors set out in subsections 9(9) to 9(23) apply only to material contribution to, or aggravation of, diabetes mellitus where the person's diabetes mellitus was suffered or contracted before or during (but did not arise out of) the person's relevant service.

11           Factors referring to an injury or disease covered by another Statement of Principles

In this Statement of Principles:

(1)          if a factor referred to in section 9 applies in relation to a person; and

(2)          that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(3) of the VEA;

then the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.

 

Schedule 1 - Dictionary  

Note: See Section 6

1               Definitions

In this instrument:

                               being exposed to arsenic as specified means:

(a)           consuming drinking water with an average arsenic concentration of at least 50 micrograms per litre for a cumulative period of at least ten years; or

(b)          consuming drinking water resulting in a cumulative total arsenic exposure equivalent to having consumed drinking water containing at least 50 micrograms per litre for at least ten years; or

(c)           having clinical evidence of chronic arsenic toxicity.

                               being exposed to second-hand smoke means being in an enclosed space and inhaling smoke from burning tobacco products or smoke that has been exhaled by another person who is smoking.

                               being overweight or obese means:

(a)           having a Body Mass Index (BMI) of 25 or greater; or

(b)          having a waist circumference of greater than 80 centimetres in women or greater than 94 centimetres in men.

Note: BMI is also defined in the Schedule 1 - Dictionary.

                               BMI means W/H² where:

(a)           W is the person's weight in kilograms; and

(b)          H is the person's height in metres.

                               diabetes mellitus—see subsection 7(2).

                               equivalent glucocorticoid therapy means a glucocorticoid in the following table, at the doses specified in the table, or a therapeutically equivalent dose of another glucocorticoid:

Glucocorticoid	Minimum cumulative dose (milligrams)	Minimum average rate (milligrams/day)
betamethasone	60	2
cortisone	1,875	62.5
dexamethasone	50	1.67
methylprednisolone	300	10
paramethasone	150	5
prednisone	375	12.5
prednisolone	375	12.5
triamcinolone	300	10

                                

                               equivalent inhaled glucocorticoid means:

(a)           8,000 micrograms of triamcinolone;

(b)          1,600 micrograms of budesonide;

(c)           1,000 micrograms of fluticasone; or

(d)          a therapeutically equivalent dose of another inhaled glucocorticoid.

                               glucocorticoid therapy as specified means:

(a)           taking:

(i)            hydrocortisone, orally, by injection, or per rectum:

A.           to a cumulative dose of at least 1,500 milligrams, and

B.            at a minimum dose rate averaging 50 milligrams per day; or

(ii)          equivalent glucocorticoid therapy, orally, by injection, or per rectum; or

(b)          inhaling at least 1,600 micrograms of beclomethasone, or equivalent inhaled glucocorticoid, daily, for at least six months; or

(c)           using an ocular or intranasal glucocorticoid at above the maximum therapeutic dosage level, daily, for at least six months; or

(d)          applying a high or very high potency topical glucocorticoid to at least 20% of total skin surface area, daily, for at least six months; or

(e)           using a glucocorticoid concurrently with a drug from the Specified List 2 of drugs, daily, for at least 30 days.

Note: equivalent glucocorticoid therapy, equivalent inhaled glucocorticoid, high or very high potency topical glucocorticoid and Specified List 2 of drugs are also defined in the Schedule 1 – Dictionary.

                               haemolytic uraemic syndrome means a clinical syndrome characterised by renal failure, microangiopathic haemolytic anaemia and thrombocytopaenia.

                               high or very high potency topical glucocorticoid means:

(a)           betamethasone dipropionate 0.05%;

(b)          betamethasone valerate 0.1%;

(c)           clobetasol proprionate 0.05%;

(d)          diflucortolone valerate 0.1%;

(e)           fluocinolone acetonide 0.025%; or

(f)           another topical glucocorticoid of equivalent potency.

                               immune checkpoint inhibitor means a form of cancer immunotherapy that uses monoclonal antibodies targeting the immune checkpoint proteins. Examples include ipilimumab, tremelimumab, nivolumab and pembrolizumab.

                               MET means a unit of measurement of the level of physical exertion.  1 MET = 3.5 ml of oxygen/kg of body weight per minute, 1.0 kcal/kg of body weight per hour, or resting metabolic rate.

                               MRCA means the Military Rehabilitation and Compensation Act 2004.

                               pack-year of tobacco products means:

(a)           20 cigarettes per day for a period of one calendar year; or

(b)          7,300 cigarettes in a period of one calendar year; or

(c)           7,300 grams of smoking tobacco by weight, either in cigarettes, pipe tobacco or cigars, or a combination of same, in a period of one calendar year.

                               relevant service means:

(a)           eligible war service (other than operational service) under the VEA;

(b)          defence service (other than hazardous service and British nuclear test defence service) under the VEA; or

(c)           peacetime service under the MRCA.

Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary.

                               Specified List 1 of drugs means:

(a)           abacavir;

(b)          alpha and beta agonists, including adrenaline and noradrenaline;

(c)           amiodarone;

(d)          beta-blockers;

(e)           bortezomib;

(f)           cyclophosphamide;

(g)          cyclosporine;

(h)          decitabine;

(i)            diadanosine;

(j)            diazoxide;

(k)          docetaxel;

(l)            emtricitabine;

(m)        everolimus;

(n)          gatifloxacin;

(o)          growth hormone;

(p)          imatinib;

(q)          isoniazid;

(r)            L-asparaginase;

(s)           lamivudine;

(t)            levofloxacin;

(u)          moxifloxacin;

(v)          nicotinic acid for the treatment of dyslipidaemia;

(w)        nilotinib;

(x)          pentamidine;

(y)          phenytoin;

(z)           protease inhibitors;

(aa)       rifampicin;

(bb)      sirolimus;

(cc)       sodium valproate;

(dd)     somatostatin analogues;

(ee)       statins;

(ff)        stavudine;

(gg)      streptozotocin;

(hh)      tacrolimus;

(ii)          temsirolimus;

(jj)          temzolomibe;

(kk)      theophylline;

(ll)          thiazide diuretics;

(mm)  thyroid hormones;

(nn)      vorinostat; or

(oo)      zidovudine.

                               Specified List 2 of drugs means:

(a)           amprenavir;

(b)          atazanavir;

(c)           darunavir;

(d)          fosamprenavir;

(e)           indinavir;

(f)           itraconazole;

(g)          ketoconazole;

(h)          lopinavir;

(i)            nelfinavir;

(j)            ritonavir;

(k)          saquinavir; or

(l)            tipranavir.

                               specified list of endocrine disorders means:

(a)           acromegaly;

(b)          Cushing syndrome;

(c)           glucagonoma;

(d)          hyperthyroidism;

(e)           phaeochromocytoma;

(f)           primary hyperaldosteronism; or

(g)          somatostatinoma.

                               specified pathological condition involving the pancreas means:

(a)           acute pancreatitis;

(b)          chronic pancreatitis;

(c)           cystic fibrosis;

(d)          haemochromatosis; or

(e)           malignant neoplasm of the pancreas.

                               terminal event means the proximate or ultimate cause of death and includes the following:

(a)           pneumonia;

(b)          respiratory failure;

(c)           cardiac arrest;

(d)          circulatory failure; or

(e)           cessation of brain function.

                               type 1 diabetes mellitus means a form of diabetes mellitus caused by complete or near-total insulin deficiency and requiring daily administration of insulin.

                               type 2 diabetes mellitus means a form of diabetes mellitus caused by variable degrees of insulin resistance and impaired insulin secretion.

                               VEA means the Veterans' Entitlements Act 1986.

 

 

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history. 

Endnote 2—Abbreviation key

	o = order(s)
ad = added or inserted	Ord = Ordinance
am = amended	orig = original
amdt = amendment	par = paragraph(s)/subparagraph(s)
c = clause(s)	/sub‑subparagraph(s)
C[x] = Compilation No. x	pres = present
Ch = Chapter(s)	prev = previous
def = definition(s)	(prev…) = previously
Dict = Dictionary	Pt = Part(s)
disallowed = disallowed by Parliament	r = regulation(s)/rule(s)
Div = Division(s)
exp = expires/expired or ceases/ceased to have	reloc = relocated
effect	renum = renumbered
F = Federal Register of Legislation	rep = repealed
gaz = gazette	rs = repealed and substituted
LA = Legislation Act 2003	s = section(s)/subsection(s)
LIA = Legislative Instruments Act 2003	Sch = Schedule(s)
(md) = misdescribed amendment can be given	Sdiv = Subdivision(s)
effect	SLI = Select Legislative Instrument
(md not incorp) = misdescribed amendment	SR = Statutory Rules
cannot be given effect	Sub‑Ch = Sub‑Chapter(s)
mod = modified/modification	SubPt = Subpart(s)
No. = Number(s)	underlining = whole or part not
	commenced or to be commenced

 

Endnote 3—Legislation history

 

Name	Registration	Commencement	Application, saving and transitional provisions
Statement of Principles concerning diabetes mellitus (Balance of Probabilities) (No. 49 of 2020)	29 June 2020   F2020L00822	27 July 2020
Amendment Statement of Principles concerning diabetes mellitus (Balance of Probabilities) (No. 84 of 2021)	30 June 2021   F2021L00927	26 July 2021
Amendment Statement of Principles concerning diabetes mellitus (Balance of Probabilities) (No. 50 of 2022)	2 May 2022   F2022L00666	30 May 2022

 

Endnote 4—Amendment history

 

Provision affected	How affected
Section 2……………….	rep LA s 48D
Section 4……………….	rep LA s 48C
Subsection 9(6)(e)…….	rs No. 84 of 2021
Subsection 9(13a).…….	ad No. 84 of 2021
Subsection 9(6)(e)…….	rs No. 50 of 2022
Subsection 9(13a).…….	rs No. 50 of 2022
Schedule 1 – Dictionary – immune checkpoint inhibitor……………...….	ad No. 50 of 2022