The government is allocating a budget of €1 million per annum for the provision of service for the treatment of people living with HIV. The Central Procurement & Supplies Unit (CPSU) within the Ministry for Health published the Request For Participation (RFP) on 22 February, the original closing date of which extended to 15 April. Four companies submitted an RFP which would cover a period of 60 months (five years).

What is expected of pharmaceutical wholesale dealers or joint ventures/consortia remains unclear. The company or companies whose bid is accepted will have to “provide a holistic service related to this chronic condition with respect to continuous monitoring, follow-ups and education to support adherence – all in line with the protocols used within the HIV clinic.” This would also include the supply of antiretroviral therapy (ARV), which is the combination of drugs prescribed to people living with HIV, as per the EACS guidelines.

The EACS guidelines are the European Guidelines for the treatment of HIV-positive adults in Europe published by the European AIDS Clinical Society (EACS). They are updated yearly, or as necessary, and provide information and recommendations to clinicians involved in the care of HIV-positive persons. The guidelines distinguish between the recommended and the alternative regimens. The alternative regimens are used when none of the preferred regimens are feasible or available, whatever the reason. The RTF does not specify which combination of regimens - recommended or alternative – the contractor would have to supply. It does not specify that a single tablet regimen would need to be supplied either. The contractor is only expected to offer the best value in terms of both quality and cost. If the cost of offering the alternative regimen is cheaper and just as good – bar more side effects – than the recommended regimen, we might end up with the provision of ARVs of inferior quality. If new drugs are included in the guidelines, the contractor is responsible to start offering them. One would assume that the real terms of how this would work will be discussed behind closed doors between the selection committee and the respective bidder at the negotiating table.

As for the education that is to be provided by the company selected, the CPSU once again refers the bidders to EACS guidelines and encourages contractors to offer the relevant support to the professionals and patients where needed without invading their privacy. But the only time education is mentioned in the guidelines is in the list of possible skills training which can be considered by clinicians. Market operators sent clarification questions, but the answers provided by the CPSU leave us none the wiser. Listed below are some questions that need to be addressed urgently by the Ministry for Health:

·     Are we to expect the delivery of educational material to newly diagnosed people to be in the hands of the contractor?

·     What is the role of the contractor in the lives of people living with HIV? How will this hybrid system between the HIV clinic and contractor work?

·     Will the operator have access to patient information? What safeguards will be put in place and what will happen when there is a breach of confidential data?

·     What is the role of the patients within this system? The paternalistic language with which the RTF is written does not augur well for present and future patients.

What remains a mystery, however, is that the purpose and scope section of the RTF recognises that “Prevention remains the cornerstone of the entire response to this epidemic.” Meanwhile, prevention strategies remain missing from this holistic service that the contractor is to provide. Provisions for Pre-exposure Prophylaxis (PrEP) – the single tablet which prevents the acquisition of HIV – is not mentioned. This is another missed opportunity for Malta to strategically decrease the number of new HIV infections by being proactive and recognising and joining international efforts to introduce PrEP. We keep seeing dramatic falls in new cases of HIV cases in countries where PrEP was introduced but in 2017, our rates of HIV diagnoses increased by 50 per cent with current statistics showing that there are 450 people living in Malta with HIV.

 

Dr Rapa is a lawyer who works as a Teaching and Research Assistant for the MA/LL.M in Healthcare Ethics and Law at the University of Manchester. He is the founder of www.prepingmalta.com, a member of the European AIDS treatment Group (EATG)