DR ALISON ANASTASI, HEAD OF OPERATIONS (PROCUREMENT), CPSU INĠ KARL FARRUGIA, MANAGING DIRECTOR (SOURCING AND SUPPLIES), CPSU

The Central Procurement Supplies Unit (CPSU) within the Ministry for Health encompasses sourcing of medicines, medical devices, materials, services, and works, amongst other varied processes. For procurement processes to be managed successfully, planning and forecasting are the mainstay. Most of the users request a specific product with a general lack of accurate data. This leads to delays in the process and further repercussions once the procurement cycle is issued. Thereby, the importance of epidemiological data has been highlighted for health conditions and ensuing treatments. The cycle is initiated by decisions and actions of the user/requisitioner. This would determine the functional and technical specifications, specific product quantity needs, estimated costs, and the transfer of approval of funding. All these practices are the backbone of an efficient procurement system.

Medicines, nutritional products, medical devices and Personal Protective Equipments (PPEs) entail specific conditions due to the specialized processes required in line with the different EU directives and regulations adopted by the Competent Authorities. For these last years, CPSU has been facing further hurdles and challenges due to the COVID-19 pandemic and the longstanding Brexit issue directly hitting the department and the access of medicines.

The department has been zealously attempting to reduce the dependency on the UK market for the last three years. This exercise has been taking up a lot of time, attention, dedication and resources. This has proved to be an arduous task, due to language barriers and the fact that most of the products sourced from the UK are not marketed in other EU member states. Economical operators were requested to start registering using the Mutual Recognition Procedure, however, there were Marketing Authorisation Holders who objected or encountered resistance due to the small size of the Maltese market.

n 2019, together with the Medicines Authority, CPSU worked on an exercise to liaise with all available Qualified Persons for Pharmacovigilance (QPPV) of economic operators, both local and foreign, to start bidding in the local procurement cycles. Economic operators are evaluated on product standards and quality, service reliability and financial viability when approved as potential suppliers before and after tendering, to avoid counterfeit and substandard medicines on the market.

CPSU managed to raise the interest of 88 different companies from different countries within the EU to quote in emergency procedures. Unfortunately, the same companies rarely make use of the normal processes, that lead to long-term deals, such as tenders. Unlike for the long-term procurement cycles, in emergency procurement CPSU registers the medicinal product or requests an exemption of registrations from the licensing authority. The local and the UK companies used to participate more eagerly in long-term processes but since there were regulatory changes due to Brexit they are simply refraining from bidding.

CPSU actively considered and tried to draw up agreements with Italy as an alternative source, but once again it was faced with language barriers as all the supplies are in Italian thus requiring translation, re-labelling and serialization – another difficult, costly and complex feat that is still not completely exhausted.

CPSU continuously organizes training and familiarization sessions to different manufacturers and suppliers to increase interest and facilitate the process. Initially, the international suppliers would be enthusiastic and eager to start business, including registering on the electronic procurement portal system (EPPS) but in the end they fail to quote.

Purchasing from a well-designed formulary involves the selection of safe and cost-effective medicines that have the greatest benefit for the patient and the lowest financial cost. To try and move away from accessing products from the UK, CPSU regularly tries to reach out to the policy unit to alter technical specifications as different formulations, active ingredients, doses, and medicines exist in other EU countries’ formularies. However, it is faced with another barrier being that the clinicians are mostly trained within the UK system, so there has been rarely such a change.

Until the beginning of 2020, CPSU managed to reduce the UK market dependency from 85% to 65% but challenges such as Brexit, local companies not being able to register their products and COVID-19 did not help.  The companies are finding resistance from the international industry to register through the Decentralized Procedure/Mutual Recognition Procedure. In 2019, the department started holding a stockpile of six months of the 766 UK originating products and this assisted treatment access during the pandemic. Since 2020, all the 2880 medicinal products are being kept up to a safety level of six months. However, the availability of the stockpiles is being continuously severed. This mainly stems from the fact that the supply in the warehouse is being impeded from reaching the patients due to recent regulatory changes. As discussed this is primarily pinned to the licences of UK products, now invalid, having to wait for the exemption approvals from the local licensing authority.

Malta has made extensive presentations on these cases in constant liaison with the relevant stakeholders, with the Permanent Representation of Malta and the EU Commission, for further consideration and support on the matter. The country has made various efforts to try and divert sourcing to other markets within the EU, which proved to be a real unsurmountable challenge.

In conclusion, the Ministry for Health is in a tight spot as CPSU is encountering situations where healthcare professionals and patients are unable to access treatment in a timely manner, even though such treatment might be available locally, within the CPSU warehouse.