Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1694265388504.pdf (Malta)
Entitlement to the Free Supply of Medicinals under the Social Security Act Final Opinion by the Commissioner for Health August 2015 Malta Entitlement to the Free Supply of Medicinals under the Social Security Act Final Opinion by the Commissioner for Health August 2015 Contents Introduction 1.

Social Security Act Interpretation of Article 23 of the Social Security Act 1 6 7 8 A.
Interpretation of Article 23 of the Social Security Act 9 B. Sub Article (1) of Article 23 10 C. Sub Article (3) of Article 23 This interpretation applied under the laws in review 11 D. Disctincion between sub article (1) and sub article (3) 13 2.

Health Act Health Act Entitlements and benefits 3.

Medicines Act 4.
Interpretation Act - the laws applied to the facts Interpretation Act 16 16 17 20 25 25 The laws applied to the facts on specific complaints Hepatitis C 26 27 Conclusion & Recommendation 31 Annexes Annex 1 - Correspondence from the Department of Health in relation to Cases HN0016 & HN0030 35 36 Annex 2 - Correspondence from the Department of Health in relation to medicines for treament of Hepatitis 43 Introduction 2 Commissioner for Health Introduction The Commissioner for Health referred to the Parliamentary Ombudsman four cases he has investigated about which he is at an impasse with the Department of Health.
He had been in correspondence with the Health Authorities over these last two years.

A.

One case concerns a Type 2 diabetic who had been prescribed Glargine Insulin by his Consultant Diabetologist.

Indeed the Consultant had certified as follows “I have prescribed Glargine as it is the best treatment for him.

The other insulin types failed to control him adequately.” The Department’s policy is to give this type of insulin only to Type 1 patients and therefore the patient was denied the treatment needed.
B.

A second case concerns patients who need to have their blood sugar levels tested at least four times a day on instructions from their Consultant Diabetologist but the Department’s policy is to provide Haemaglucotest (HGT) Blood sugar testing strips, four every day, only to patients up to the age of eighteen.

The other two cases concern patients suffering from Hepatitis C C. the treatment for which the Department of Health has not procured.

A.
A.

In the first case, this Office is of the opinion that once the medicinal is available within the health service provided by government and is indicated for the patient’s condition, the Department is wrong in insisting to give it only to Type 1 diabetic patients on the basis of a protocol which is not based on purely medical considerations and which in effect deprives the patient of his entitlement under the Social Security Act.
In the second case, this Office is of the opinion that age should not B. be a determining factor.

In the circumstances of this case the decision of the Health Authorities is improperly discriminatory and is in violation of the fundamental right to equality and non-discrimination.
This Office had already, in a case some years back, given its opinion on an analogous case of discrimination because of age, in respect of treatment with statin Opinion on the Entitlement to the Free Supply of Medicinals 3 preparations, aimed at lowering cholesterol levels in the blood.

Following this opinion the Health Authorities removed this discrimination and made the treatment available, where indicated, irrespective of age.
Moreover, HGT strips can be used as a glycaemia control measure to prevent serious complications.

Indeed, in the document circulated to those who on 14 November 2014 attended the Seminar organised by the Health Promotion and Disease Prevention Directorate, on “Diabetes: A National Public Health Priority - Proposal for a National Strategy for Diabetes” it is stated that “admissions (to Mater Dei Hospital) for lower limb ulcers and gangrene constitute the “vast majority”.
Diabetic Ketoacidosis/ Hyperglycaemic hyperosomolar syndrome and hyperglycaemia are the other complications that arise from inadequate glycaemic control.”1 Adequate glycaemia control can be obtained by checking with HGT strips.

C. In the two cases referred to paragraph C, patients suffering from Hepatitis C are being denied the treatment that is indicated for their serious condition because the health authorities are refusing to provide it due to financial contraints.
This even though the condition is listed in Part II of the Fifth Schedule to the Social Security Act.

A fact that entitles these patients to a free supply of the indicated treatment.

1 Page 28 of the document Applicable Laws 1.

Social Security Act 2.

Health Act 3.

Medicines Act 4.

Interpretation Act 1.

Social Security Act 6 Commissioner for Health 1.


Social Security Act Entitlement to free medicines available from the Government Health Service stems from the provisions of the Social Security Act (Cap 318).

Article 23 of the Act states as follows: “23.
(1) Subject to the provisions of this Act, a person who is the head of household shall be entitled to such Free Medical Aid as is specified hereunder, that is the supply of such drugs, spectacles, dentures, and other prosthetic aids as in the opinion of the Chief Government Medical Officer are indicated in his case according to protocols which may be issued by him from time to time and are available, if he shows to the satisfaction of the Director that – (a) on account of bodily or mental impairment, sickness or disease, which does not require treatment in a hospital, he or any member of his household is in need of medical, surgical or pharmaceutical aid; and (b) the total weekly means of all the members of his household calculated in accordance with the provisions of Part III of the Second Schedule to this Act do not exceed the scale rate for that household, as determined by the Eighth Schedule to this Act: Provided that the Chief Government Medical Officer shall consult, before forming his opinion, with one or more medical consultants drawn from a panel appointed by the Minister:…” Under the same Article, “(3) A person suffering from one of the diseases or conditions specified in Part II of the Fifth Schedule shall be entitled to such Free Medical Aid as in the opinion of the Chief Government Medical Officer are indicated in his case according to protocols which may be issued by him from time to time and are available within the national health service.” Interpretation of Article 23 of the Social Security Act 8 Commissioner for Health Interpretation of Article 23 of the Social Security Act A.
Interpretation of Article 23 of the Security Act Article 23 of the Security Act should be interpreted in the light of the following considerations:- a) the Social Security Act expressly gives a person who satisfies the established criteria an entitlement for free medical aid within the terms and conditions laid down in the Act.

The term “entitlement” gives such individual a right at law to claim from the State the free treatment to which he is entitled.
A right that is necessarily reflected in a corresponding duty of the health authorities to make such treatment available to him.

b) the same article provides that the Chief Government Medical Officer (CGMO) may issue protocols stating the criteria for prescribing and dispensing of particular medicines in the health service provided by Government.

The term “may” in this context is not meant to imply that the CGMO has a discretionary power to make or not to make such protocols.
He is bound to issue them to give effect to the provision of the law and the term must therefore be understood to mean an imperative “shall”; c) protocols that the CGMO may issue from time to time, can only be made by him for the purpose of regulating the modalities of how the treatment to which the person is entitled has to be prescribed.

These can in no way be intended to restrict the right to treatment to which a person is by law entitled.
Even less can they be issued in a manner that will neutralise that right.
Indeed, the law empowers the CGMO to issue such protocols as are in his opinion, indicated to provide the required treatment to satisfy that right; this means that, if the CGMO does not issue such a protocol for d) any particular medical product a person who is entitled to free medical aid in terms of this article would have the right to receive any treatment that was available, and is indicated for the condition he/she suffers from; and Opinion on the Entitlement to the Free Supply of Medicinals 9 similarly, this article imposes on the CGMO the duty to make e) available treatment for a patient’s medical condition once it is proved that he is entitled to free medical aid in terms of sub article (1) of Section 23 of the Act.
The CGMO cannot neutralise the provisions of the Act and deny free medical aid to persons who are entitled to it simply by not making the treatment available.

On the other hand it is the CGMO who determines what treatment is indicated for the patient’s condition and he has the duty to ensure that the relative medicines are available.

The person eligible for treatment has no right to contest the exercise of discretion2 by the CGMO in this respect.
Even less has he got the right to expect and demand alternative treatment to that established in the protocols.

In fact, it is the Director of Social Security who determines whether a person is entitled to free medical aid in terms of sub article (1) of Article 23 of the Act, once he satisfies the conditions laid down in the Act.

It is then the duty of the CGMO to supply that person with the free medical aid to which he is entitled and which is, in his opinion, indicated for his medical condition.
However in forming his opinion he should consult one or more medical consultants in his Department.

These are the correct checks and balances that the law provides to verify and control a fair, just, transparent and accountable system of free medical aid to those who are really in need.

A system that is one of the main pillars of social security in Malta, that has for years provided and guaranteed a strong safety net of medical treatment for those households who could not afford it.
B. Sub article (1) of Article 23 The creation of a Welfare State, of which the country is justly proud, places 2 The fact that the CGMO has such discretion imposes on him the obligation to exercise this discretion fairly and in full respect of the law and the patent’s entitlement at law.

In individual cases the CGMO has to give due consideration to consensus medical opinion regarding the med- ical indications of the particular drug or medicine and the patient’s specific needs for his medical condition.
10 Commissioner for Health households at the centre of social solidarity.

Parliament willed that the whole community has to bear the cost of providing essential free medical aid to those who really need it and cannot afford it.

Though issues of affordability and sustainability have to be addressed, these have to be secondary considerations when determining policies that can in any way curtail or imperil the right that entitled households have to free medical aid.
In this context the legislator had these households as his main concern when enacting the Social Security Act.

Therefore, in case of doubt as to the interpretation of that law and other laws that could negatively affect its application, that doubt should go in favour of those households.

There is another point to be made.
Once the Director of Social Security certifies that a household is eligible for free medical aid, having certified that it satisfies the means test laid down in the law, and a member of his household is in need of medical, surgical or pharmaceutical aid that does not require treatment in hospital, the CGMO is in duty bound to provide that household with the free medical aid it requires for the particular ailment, irrespective of the nature of the bodily or mental impairment, sickness, disease or condition that the member of that household is suffering from.
Households eligible for free medical aid under Sub article (1) of Article 23 have a blanket provision for free medical aid exclusively on the grounds that the level of their income does not allow them to meet such cost.
It is therefore incomprehensible that according to information which this Office had in the past, there were instances where protocols specifically excluded patients entitled on the basis of a means test from receiving a medical aid because one of the conditions of the protocol was that the disease he was suffering from was not listed under the Fifth Schedule to the Act.
C. Sub article (3) of Article 23 Free medical aid extends also to diseases or conditions specified in Part II of the Fifth Schedule to the Act, regulated by sub article (3).

The right to free medical aid enjoyed by these patients cannot be affected by any Opinion on the Entitlement to the Free Supply of Medicinals 11 limitation or restriction made by the CGMO to regulate the prescription of treatment for diseases or conditions specified in Part 2 of the Fifth Schedule.
Though most of the considerations made above regarding free medical aid to which eligible households are entitled under sub article (1) apply also to persons with free medical aid under sub article (3) it would appear that the CGMO has a somewhat wider discretion as to what medical aid should be freely made available to these latter persons.

Indeed, this sub article specifically states that the medical aid to be dispensed to these eligible persons must be “available within the National Health Service”.
No such limitation is made in sub article (1) and it would be therefore reasonable to assume that in these cases the CGMO has to provide the treatment that is, in his opinion, indicated (even if it is only available outside the National Health Service).
Financial constraints and economic considerations can be a factor in determining the availability of free medical aid under sub article (3), but these can under no circumstance nullify or restrict the free medical treatment which is indicated and to which these eligible persons are entitled by law save in case where making available such treatment endangers the sustainability of the health service provided by Government.
This interpretation applied to the cases under review In particular:- persons suffering from any one of the diseases or conditions i) specified in Part II of the Fifth Schedule cannot be denied the right to free treatment by medicines which are available in the National Health Service, either through the introduction of restrictive protocols not based on medical grounds or even worse, simply because the authorities fail to provide the drugs required for treatment and this for whatsoever reason.
The health authorities have no right to bypass the will of Parliament, decreeing that a person suffering from a specified disease or condition is entitled to free medical treatment, simply by failing to publish the necessary protocol, by publishing protocols which are in part or in whole, not based on the 12 Commissioner for Health medical indications mentioned by the Act, as one of the pre requisites, or even worse, by not making the required treatment available to these patients, and all the more so when it is otherwise available in the National Health Services for other conditions.
In the Seminar document referred to earlier in this document it is stated that “they (the diabetics) might also perceive themselves as an added burden to the family especially with regards to costs involved in the procurement of medicines and items which are not covered by the Government Formulary, therefore putting an extra financial burden on the family.
For example, the treatment of Osteomyelitis, a known complication of diabetes, requires prolonged treatment with expensive antibiotics which is not affordable for many persons.

These end up having an amputation simply because they did not adhere to the treatment prescribed.

Entitling these persons to free antibiotics and the necessary dressings would help reduce complications”3.
This Office is of the opinion that entitlement to treatment of diabetes necessitates treatment of the complications of the illness.

Failure to provide such treatment means that the patient will not receive proper treatment for the condition.

It would not make sense not to treat the complications.
This is another example where the protocols are not based on medical considerations, but the measure applied by the health authorities is not, in the final analysis cost effective when one considers the expenses to be incurred on surgery, hospital stay, post- operative treatment, physiotherapy, occupational therapy, and provision of prosthesis etc.. Failure to treat complications of Diabetes will not only cause disfigurement to the patient but it is also degrading and humiliating.
It would not be amiss to point out that last year no less than 513 amputation procedures were carried out at Mater Dei Hospital.

Of these 426 were toe amputations and 87 were foot and leg (below knee and above knee) amputations.

The majority of these were due to a complication of diabetes (gangrene).

Adequate control of the disease and proper treatment would have averted the complications.

ii) improperly discriminatory.


any exercise of discretion by the CGMO should not be in any way This means that financial and economic 3 Page 81 of the document.

Opinion on the Entitlement to the Free Supply of Medicinals 13 considerations could affect the type and supply of free medicines and drugs that the country could afford in order to sustain the health service.
It is recognised that budgetary exigencies necessarily influence the availability of drugs and medicines and that one has therefore to prioritise how available funds are to be utilised.

However, the drawing up of protocols regulating treatment in respect of specified diseases or conditions, must necessarily be made on medical grounds and cannot for any other reason improperly discriminate between one class of eligible patients and another.
This Office therefore considers that once a medicinal product is available under the health services provided by Government, and medical opinion agrees that it is indicated for the particular patient’s condition, protocols which are not based on medical indications go against the spirit, if not also the letter of the Social Security Act.
D. Distinction between sub article (1) and sub article (3) Indeed, the distinction between the dispensing of free medical aid under sub article (1) and sub article (3) of article 23 of the Social Security Act is clear and needs to be kept in mind.
While the entitlement to free medical aid to households eligible under sub article (1) is exclusively based on a means test, that, if passed, would entitle all members of that household to free medicines and other medical aids, in sub article (3) entitlement to free medical aid is given to a person suffering from one of the diseases or conditions specified in Part II of the Fifth Schedule irrespective of that person’s financial means or whether he could or could not afford to pay for such treatment.
Clearly the raison d’etre of the legislator when providing for two different situations for entitlement to free medical aid in these two sub articles is completely different.

In sub article (1), the legislator discriminates by positive action in favour of indigent households that it considers could not provide for its medical expenses.

The State assumed the duty to provide for any essential medical treatment required by that household, irrespective of the nature of the disease or condition.
A proper discrimination that imposes on the State the duty to make available to 14 Commissioner for Health those eligible households the free medical aid to which they were entitled even if in circumstances where such medical aid is not available with the National Health Service.

In fact as distinct from sub article (3) the term used in sub article (1) is “available” while in sub article (3) the term used is “available within the National Health Service”.
In sub article (3), the entitlement to free medical aid is not bound to any means test.

It is directly related to the nature of the disease or condition suffered by a person, identified and listed in Part 2 of the Fifth Schedule.

There could be a variety of reasons why diseases or conditions are specified by the legislator in the Fifth Schedule.
The cost of the treatment could be one factor but there could be others like for example the gravity of the disease or condition, how widespread it is and the need to encourage people to take the necessary treatment, and also possibly not excluding the fact that failure to treat the condition may lead to serious complications, the treatment for which could be an added burden to the health service.

This distinction is very relevant to the matter of availability.
In the case of households eligible under sub article (1), the State has assumed a duty of care to provide them with the free basic medical aid required in their particular case.

A duty of care that is absolute, even if limited by the modalities how the free medical aid is to be prescribed.

The State must therefore undertake to make available the medical aid to which these households are entitled.
In this case, financial and economic constraints can presumably affect the type of treatment made available, but they can never deny it to the detriment of patients.

In the case, of sub article (3) entitlement is directly related to the nature of the disease or condition, to its being specified in Part II the Fifth Schedule and the entitlement is in effect limited to the treatment of that condition.
In these cases, the legislator entitles a person suffering from one of the specified diseases or conditions to the right to receive free medical aid.

The nature and quality of the aid to be dispensed is to be determined by a) “as in the opinion of the Chief Government Medical Officer are indicated in his case”, b) “according to protocols which may be issued by him from time to time”; and c) “are available within the National Health Service” for persons/patients to be entitled.

2.
2.

Health Act 16 Health Act Commissioner for Health Part VII of the Health Act 2013 (Cap.528) refers to Health Care Benefits and Entitlements.

Article 21 and 22 provide, inter alia, as follows: “21.

The Minister shall establish the healthcare benefits that are to be provided directly or indirectly by the public healthcare system, after considering the advice of the Advisory Committee on Healthcare Benefits established in article 23.

22.
22.

(1) There shall be established an Advisory Committee on Healthcare Benefits.

(2) The Advisory Committee on Healthcare Benefits may set up sub-committees to deal with different and specific categories of benefits as it may deem necessary.
Without prejudice to the generality of the foregoing, the Government Formulary List Advisory Committee established by the Availability of Medicinal Products within the Government Health Services Regulations shall be deemed to be one of the aforementioned sub-committees.

… (5) The Advisory Committee shall retain the right to advise the Minister to restrict any form of entitlement on the basis of protocols4.

23.
23.

(1) It shall be the duty of the Committee to recommend the healthcare benefits to be provided directly or indirectly by the public healthcare system and to maintain a publicly accessible list of such benefits regularly updated.
It is also pertinent to add that paragraph 22(5) of the Health Act states that “the Advisory 4 Committee shall retain the right to advise the Minister to restrict any form of entitlement on the basis of protocols.” One has also to say that the Chairman and members of this Advisory Committee who advise the Minister, are all appointed by the Minister in terms of paragraph 22(3) and Schedule C to the Health Act.

However, no restrictions have been made under this Act.
Opinion on the Entitlement to the Free Supply of Medicinals 17 (2) In formulating the list, the Committee shall primarily base its consideration on the impact of such benefits on the patient and subsequently shall be guided by the following: (a) international evidence; (b) health technology assessments; (c) consultation with relevant stakeholders; (d) capacity within the public health system; (e) social and epidemiological considerations; (f) affordability and sustainability.” Article 27 of the same Act provides amongst other rights, for the right of every patient “to receive healthcare in accordance with the provisions of this Act.” It is reasonable to consider that the Health Act does not abrogate any patient’s rights under the Social Security Act and all the more so, when no limitations on the health services have been made under the Health Act.
Entitlements and benefits Article 21 of the Health Act empowers the Minister “to establish the health care benefits that are to be provided directly or indirectly by the public health care system …”.

The term “benefits” is not to be confused with the term “entitlement” used to describe the rights conferred in Article 23 of the Social Security Act.

Those entitlements cannot be subject to any ministerial discretion.
They are established by the law that also provides for the manner in which such entitlement is to be verified, determined and delivered to entitled persons.

18 Commissioner for Health It is true that sub article (5) of Article 21 of the Health Act provides that “the Advisory Committee (on health care benefits) shall retain the right to advise the Minister to restrict any form of entitlement on the basis of protocols”.
There is no cross reference in this section or any other section in Part VII of the Health Act to the Social Security Act.

It is therefore difficult to understand how this sub article can be utilised to restrict the right of households and persons to free medical aid when that entitlement is determined according to criteria established in another law, the Social Security Act.
An entitlement that gives the household or person the right to the supply of such drugs and other medial aids as in the opinion of the CGMO - and not the Minister - are indicated in his case, according to protocols which may be issued by him from time to time.

Protocols that can only be safely and reasonably interpreted to refer to the nature of the medical disease or condition and the treatment that is indicated.
This does not mean that in the drafting of these protocols the CGMO or indeed the Minister cannot take the advice of the Advisory Committee set up under the Health Act.
However, when interpreting and applying these protocols for the purposes of Article 23 of the Social Security Act, the CGMO has to be constantly aware that that law provides that- 1. persons who are in the low income group, as determined by a means test, are entitled to free medicines specifically needed for his condition and to certain medical devices; and 2. persons who suffer from chronic illnesses, included in the Part II of the Fifth Schedule to the Act, are entitled to free medicines strictly related to the chronic illness in question - an entitlement that is independent of financial means.
Such entitlement cannot be denied or restricted through protocols that are not wholly based on purely medical considerations.

Protocols can only determine the limits and modalities how those entitlements can be satisfied.

Opinion on the Entitlement to the Free Supply of Medicinals 15 3.

Medicines Act 20 Commissioner for Health Medicines Act Another legislation on the Statute which deals with medicines is the Medicines Act (Cap 458).
This Act makes various provisions in respect of quality of medicines, licencing of pharmaceutical products, importation and sale and supply thereof, etc.

The law does not contain any provisions relating specifically to the Government Formulary or the availability of medicinal products in the Government Health Services or to entitlement to free medicines.
Article 106 empowers the Minister responsible for Health to “…prescribe by regulations anything that may be prescribed under this Act and make provision on any matter relating to medicinal products, poisons and pharmacies in order to give fuller effect to the provisions of this Act…”.
Without prejudice to the generality of this provision such regulations may provide (amongst others) for “(d) the sale and supply of medicinal products.” Subsidiary Legislation 458.31 deals with availability of medicinal products within the Government Health Services.

These regulations were published under LN 58 of 2009 and were made in exercise of the powers conferred by Article 106(d) of the Medicines Act quoted above.
The primary objective of these regulations (Reg 2) “…is the promotion of public health by ensuring the availability of adequate supplies of medicinal products at a reasonable cost in Government Health Services”.
Paragraph 2 of Regulation (2) states that these regulations shall apply where the holder of a marketing authorisation, wishes to apply for the inclusion of a medical product in the list of medicinal products covered by the Government Health Services hereinafter referred to as the Government Formulary List and are without prejudice to the power of the Superintendent of Public Health to “…include any medicinal product in the Government Formulary List”.
The Superintendent of Public Health “… shall be assisted by the Government Formulary List Advisory Committee” (all members including Chairman are appointed by the Minister).
Opinion on the Entitlement to the Free Supply of Medicinals 21 Regulation 5(3) provides as follows: “(3) The Government Formulary List shall include conditions specific to coverage within the Government Health Services in terms of entitlement to free medicines, supply within the Government Health Services (primary and secondary care, use in specific clinics or hospitals), prescriber criteria and use within the Government Health Services (specific prescribers, conditions for prescribing, protocols, therapeutic guidelines or clinical guidelines).” … 8.
(1) Any decision to exclude a medicinal product from the Government Formulary List, shall contain a statement of reasons based on objective and verifiable criteria.

Such decision including, if appropriate, any expert opinions or recommendations on which the decisions are based, shall be communicated to the person who is responsible therefore.

… 10.
… 10.

(1) Any decision made under regulations 7, 8 and 9 may be appealed from before the Government Formulary List Appeals Committee, hereinafter referred as “the Appeals Committee”.

… (8) The decisions of the Appeals Committee shall be in writing and shall be deemed final and conclusive and shall not be subject to review by the ordinary courts of law except on points of law.” Regulation 7 provides as follows: “7.
Any decision not to include a medicinal product in the Government Formulary List shall be communicated to the applicant and it shall contain: (a) a statement of reasons based upon the criteria in 22 Commissioner for Health Schedule II, including, if appropriate, any expert opinions or recommendations on which the decision is based; (b) information about the remedies available to the applicant under the laws in force and of the time limits allowed for applying such remedies.” Schedule II to these Regulations lists the criteria to be taken into account in deciding whether or not to include a medicinal product on the Government Formulary List.
Among these one finds the following: “Entitlement to free medicines as specified in the Social Security Act, Cap.

318, article 23 and the Fifth Schedule Part II to the same Act regarding Diseases and Conditions in respect of which Free Medical Aid may be accorded, as well as medicinal products required for the provision of care within Government Institutions.
A medicinal product or a category of medicinal products to treat conditions which fall outside the scope of the Government Health Services may be entirely excluded from the Government Formulary List.
… Cost and economic evaluation such as the conditions for the supply, prescription, use and monitoring of the medicinal product, affordability by the national health services and the social and epidemiological impact shall be taken into account in determining the coverage of a medicinal product by the Government Health Services.” There may be serious reservations as to the vires or the applicability of these regulations in respect of patient entitlement.
The main law, under which these regulations were prescribed, does not refer to entitlement to medicinal products in the Government Health Services.

The vires referred to in these regulations is Article 106(b) (“the sale and supply of medicines”) of the Medicines Act.
Opinion on the Entitlement to the Free Supply of Medicinals 23 The provisions dealing with the sale and “supply” of medicinal products under the Medicines Act are aimed at establishing safe and controlled practices in the procurement, sale and supply of medicines including dispensing of medicinals in local pharmacies and not to limit in any way the citizen’s right to such medicines as provided under other laws.
This Office is citing the provisions of these regulations because the Health Authorities are themselves invoking these regulations to justify their stand.

4.

Interpretation Act - the laws applied to the facts 26 Commissioner for Health Interpretation Act It may also be relevant to consider Article 10 of the Interpretation Act which states as follows: Where by virtue of any Act, whether passed before “10.
or after the commencement of this Act, power is conferred to make subsidiary laws, and subsidiary law that may lawfully be made thereunder shall be valid and shall have effect whether or not it purports to be made in exercise of those powers and even if it purports to be made in exercise of other powers.” The laws applied to the facts of specific complaints A.
In summary, the Social Security Act gives the right for a patient to be given the required medicines free of charge, under the following conditions: a. that the patient is entitled (through pink form or yellow card); b. the medicinal is indicated in one’s condition; and c. the medicinal is available.

This Office re-iterates that once these three conditions are satisfied, the Department has no right to refuse treatment.
Yet the Department is contending that a patient must also satisfy the protocols which it is empowered to make in terms of the Act even if the protocols may not be based on purely medical indications as may be implied in the same Act.

The Department has created protocols which are not based only on purely medical indications but as a tool to refuse treatment because of financial constraints.

In the first case regarding Glargine Insulin, the protocol states that it is to be given only to Type 1 diabetics.
As a result, the patient has been refused treatment despite that his Consultant Diabetologist has certified that “the other insulin types failed to control him adequately.” Opinion on the Entitlement to the Free Supply of Medicinals 27 In the second case the Department is restricting the number of HGT strips to over 18 years old when medical indications dictate otherwise.

In other words, there is age discrimination which is not made on medical grounds.

Such discrimination is improper and contrary to law.
This Office has already, in an analogous case in the past, expressed its opinion to this effect and recommended that such discrimination be removed.

The Department of Health had agreed.

In making these limitations for financial/economic reasons the B.

Department of Health is quoting the Fiscal Responsibility Act “which empowers ministries to work within available budgetary frameworks to ensure fiscal responsibility”.
Hepatitis C Reference has also been made to the fate being faced by patients suffering from Hepatitis C. Hepatitis C was included in Part II of Schedule V to the Social Security Act, through Act I of 2012, on 3 February 2012.

It is an infectious disease and listed as such in the Schedule.
Despite that three years have passed from the relative Parliamentary decision, the Department of Health has not yet taken steps for the procurement of the required medicines to treat this condition, the reason being financial costs.

As stated earlier correspondence on this matter between the Health Authorities and this Office has been going on since 12 November 2012.
In 2012 the only treatment indicated for this medical condition was valued at approximately €18,000 per patient and the more recently recommended treatment (Harvoni regime), which has the potential to offer 95% cure, costs approximately €75,000 per patient.

This Office has been requested by two patients to intervene on their behalf.
One patient is a haemophiliac and had contracted Hepatitis C because he had been given, around thirty years ago, contaminated blood products imported by the Department of Health.

His Consultant has 28 Commissioner for Health certified that “… it is hereby being recommended from the clinical point of view that the patient receives this treatment as soon as possible as this will impact the long term prognosis in his case.
Failure to do this will result in deterioration of his liver function and more medical care needs with further life-damaging consequences”.

In the second case his Consultant has certified that “… given that the patient has thalassemia he should be regarded intolerant of Ribavirin.

In my opinion he should be treated with all oral anti-viral agents (the Harvoni regime without Ribavirin).
It is highly likely that eradicating the virus will stabilise his liver condition and reduce the chance of him developing complications that may require transplantation or expensive interventions”.

This Office has received expert opinion to the effect that in about 20% of the patients who suffer from Hepatitis C there are strong indications that such patients, if untreated, will develop liver failure or cancer.
Some of these complications would require liver transplant followed by very costly anti-rejection drugs – apart from putting their lives very much at risk.

This Office has made further enquiries and it resulted that at the moment, there are about 35 patients who need the new treatment which needs to be started as soon as possible.

The cost would be in the region of €2,600,000.


It is true that this new treatment would result in quite a financial burden but, at the same time, it is also true that the patient has been granted the right to have such treatment free of charge.
Although it is extremely likely that the availability of the newly introduced treatment regime will in the long run, result in savings due to prevention of more serious complications which in turn require available treatment but which may be even more costly regarding the quantum of such savings, this Office is not in a position to know the savings that would accrue if the patients would not need liver transplantation and the resulting, post- transplant anti-rejection drugs.
Opinion on the Entitlement to the Free Supply of Medicinals 29 This Office considers that once Parliament has decided, in 2012, to give new hope to Hepatitis C patients, the Health Authorities are not acting correctly when they are not making the treatment available because of financial considerations.
Conclusion & Recommendation 32 Commissioner for Health Conclusion and Recommendation The Commissioner for Health is of the opinion that, contrary to what the health authorities are maintaining, all complainants in the cases mentioned above are eligible for free medical aid in terms of the Social Security Act.

Denying them their entitlement is causing them an injustice that needs to be remedied.
The Ombudsman and the Commissioner for Health recommend that a review of applicable legislation is carried out to ensure clarity and legal certainty about the rights of persons entitled to receive free medical aid in terms of Article 23 of the Social Security Act.
A review that should ensure that regulations/policies/protocols made by the competent authorities that determine, limit or condition the right of households or persons to receive free aid to which they are entitled, have the necessary vires in terms of the law under which they are issued.

Moreover, and more importantly, these regulations must reflect not only the word but also the spirit of the Social Security Act as expressed by the people’s representatives in Parliament.
The Social Security Act justly imposes on society a compulsory, contributive insurance for the benefit of the common good.

It creates a social contract that entitles eligible persons to legislated benefits but also imposes on the State a corresponding obligation to deliver them.
Fiscal and economic considerations in the management of available funds are primarily aimed at securing essential Opinion on the Entitlement to the Free Supply of Medicinals 33 treatment to indigent households and/or persons suffering from serious and life threatening diseases or conditions - the most vulnerable sections of society.
Annexed to this Opinion is the relative documentation that illustrates the position of the health authorities in refusing the recommendation of the Commissioner for Health to uphold these complaints.
Charles Messina Commissioner for Health Joseph Said Pullicino Parliamentary Ombudsman Annexes 36 Commissioner for Health Annex I - Correspondence from the Department of Health in relation to Cases HN0016 & HN0030 Opinion on the Entitlement to the Free Supply of Medicinals 37 38 Commissioner for Health Opinion on the Entitlement to the Free Supply of Medicinals 39 40 Commissioner for Health Opinion on the Entitlement to the Free Supply of Medicinals 41 42 Commissioner for Health Opinion on the Entitlement to the Free Supply of Medicinals 43 Annex II - Correspondence from the Department of Health in relation to medicines for the treatment of Hepatitis 44 Commissioner for Health Opinion on the Entitlement to the Free Supply of Medicinals 45 46 Commissioner for Health Opinion on the Entitlement to the Free Supply of Medicinals 47 48 Commissioner for Health Office of the Parliamentary Ombudsman 11, St Paul Street, Valletta - VLT1210 Tel: +356 2248 3210 Email: office@ombudsman.org.mt www.ombudsman.org.mt