Anomalies in medicine’s entitlement Protocols cause hardship to patients

Case Notes investigated by the Commissioner for Health

The complaint

A pensioner suffering from a permanent and progressive respiratory deficiency, complained with the Office of the Ombudsman that even though he was a pink form holder, issued to persons in a precarious financial situation, the Health Department, was not providing him the more expensive medicines.

The complainant argued that being on state pension, the extra expense to acquire the needed medicines caused him ‘a serious financial problem’. The complainant asked the Office of the Ombudsman to intervene in this matter.

Facts and findings

When asked for the reaction, the Chief Medical Officer, of the Department for Health, told the Commissioner that although a patient may be in possession of a Schedule V and/or Schedule II (pink card) entitlement as per Social Security Act, free medicines entitlement was also affected by their availability in the Government Formulary List (GFL) and also by government protocols. The Health Department pointed out that certain medicines were not available in the GFL and therefore no free entitlement was available for these medicines. The Chief Medical Officer suggested that the patient may consult his medical doctor on possible alternative treatment available on the GFL.

After an exchange of correspondence between the Commissioner and the Department for Health, it resulted that the protocol does not permit that the required medicines be given to pink form holders. The Department explained that the medicines in question were not approved for the treatment of Chronic Respiratory Failure but are approved for Chronic Kidney Disease.


The Commissioner argued that protocols should not be made to preclude entitled persons to be given what they were entitled to by right in terms of the Social Security Act. He explained that the complainant developed the condition as a result of the treatment that was prescribed to him for the Chronic Respiratory Failure. The medicines which he was requesting were listed on the GFL and were indicated for treating the result of side effects/complications for the treatment of the complainant’s condition. Therefore, the Commissioner, insisted that refusing to allow the patient to avail himself of this treatment available on the GFL could be tantamount to denying a patient to the full treatment as was medically indicated for his condition.

The Commissioner continued by asking if it was legally correct to have rigid protocols which, in effect deny a patient from his right to have free medication for his specific condition because of possible side effects which could be overcome by additional medication which was not indicated for the original illness. This meant, the Commissioner continued, that side effects produced by medicines were being ignored for the simple reason that they do not fit into the protocol.

The Department for Health explained that protocols, which governed entitlement to free medicines were based upon medicines indications, established international guidelines, and affordability by the National Health Service. The Department noted that whenever possible alternative treatment available on the GFL was prescribed if the patient develops a side effect related to the treatment he was given.

Conclusions and recommendations

The Commissioner for Health, concluded that, Section 23(1) of the Social Security Act lays down three conditions namely:

1. Entitlement
2. Indication
3. Availability

He stated that once these conditions are satisfied, a patient cannot be denied free supply of medicines irrespective of whether it is Schedule V or Pink Form. The Commissioner observed that if this principle was not accepted, it would consequently discriminate against Pink Form patients.

In his conclusions the Commissioner, quoted a letter sent by the Department for Health, (on a different but similar case), which undertook the commitment to rectify anomalies in the way protocols are written. In the mentioned letter, the Chief Medical Officer stated that the department will “instruct the Director of Pharmaceutical Affairs to ensure that in future, wording of protocols carefully reflects the scope of entitlement restrictions”.

In view of this and in terms of Section 22 of the Ombudsman Act, 1995, the Commissioner requested to be informed of what action was being taken in line with his recommendations.

The matter will continue to be followed.

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