Patients uninformed about change in medicines
• Ministry says change was made in line with regulations
Some patients were not informed about changes being made to the medicines they were to receive, The Malta Independent is informed.
Certain patients with chronic illnesses who went for their usual treatment in hospital found that their medication is no longer available, and that it had been switched to a cheaper alternative.
The issue revolved around some biological agent (biologicals) medicines being switched to biosimilars - medicines that are developed in laboratories as an alternative to the original biological medication. The Health Ministry, however, said that this change was made in line with public procurement regulations and competition laws.
One specific case involves an individual who lives with Crohn’s Disease, an inflammatory bowel disease, which can be treated through a number of medicines. This patient, however, was stabilised on a particular medication called Remicade.
Remicade is part of the class of medicines known as biologicals, as it uses an animal protein to hinder the inflammation process.
This patient went to hospital to get their usual treatment, but they were informed that the health authorities are no longer purchasing Remicade and are imposing a new medicine; Remsima. This medication classifies as a biosimilar.
Notably, the patient was not contacted or informed about these changes prior to their appointment, this newsroom was told. On top of that, the new medication does not work on the patient and the original medication is no longer available.
The patient explained that he was told that this change had been planned since 2016, despite it being scrutinised by various medical consultants and professionals. Additionally, doctors, nurses and pharmacists were only informed about this switch at the last minute via email and had to face angered patients who were not informed at all about it, this newsroom is informed.
Sources suggested that this change might have been made for economic reasons, as biosimilars are typically cheaper than the biological counterpart.
“It is useless trying to save money on this issue if the new medicine does not agree with the patient, as this can lead to more costs in tests and hospital procedures,” they said.
They explained that this situation has caused a lot of confusion and disappointment in patients who have had their medication changed unknowingly and felt that the government is trying to save money off of their backs - “this is a procurement mess up, possibly obeying orders from further up.”
The Malta Independent asked the Health Ministry why this switch was not communicated with the patients and if it was done from economical gain.
The Ministry did not give a direct answer to these questions, however, it did say that Public Procurement Regulations and competition laws stipulate that procurement of medicines should be led by nonbranded specifications (as is the case for biosimilars).
“In line with these requirements, initiatives have long been taken to switch patients from biologicals to biosimilars which are registered by the Medicines Authority.”
The patient in question was also informed that Spanish, Portuguese, Greek and Italian health authorities managed to negotiate a discounted price with the company that produces the original biological. Sources explained that Maltese medical consultants had suggested for this kind of negotiation to take place, but it was never acknowledged.
This newsroom asked whether the Health Ministry had considered asking the manufacturer for a discounted price, but no reply was provided.
However, it explained that when clinicians notice adverse drug reactions to the biosimilar medication, as with any medicines, the Malta Medicines Authority is duly informed for any further investigations deemed necessary. In cases where these reactions are confirmed, an application is filed for the original branded biological medicine to be procured through the Exceptional Medicines Treatment Committee, if the request is deemed valid.
“These principles are applied for all biological medicines. Each medicine imported to Malta is ascertained to be safe and efficient during the registration process,” the spokesperson for the ministry added.