Medicines tendering process needs updating, sector experts tell MPs

The tendering process for medicinal products is in need of an update, and should be addressed at EU level, pharmaceutical experts told parliament’s health committee on Monday.

Parliament’s health committee held an emergency meeting to discuss the local shortage in medicines.

They called in top brass from public and private entities to understand what’s leading to the shortage and how it compares to other countries.

“Having nothing out of stock is almost impossible,” said Karl Farrugia, Managing Director of the Central Procurement & Supplies Unit (CPSU).

He explained that the unit is the largest pharmaceuticals importer in the country and employs a stockpiling strategy to ensure an adequate level of medicines on local pharmacy shelves.

Farrugia said that the list of medicines that are out-of-stock is everchanging. He added that a shortage in government stock does not necessarily mean that pharmacists don’t have that medicine in stock either.

He continued to explain that the CPSU has an emergency response unit, which is tasked with purchasing products that are out of stock. Alison Anastasi, Head of Procurement at the CPSU, said that this unit would only be resorted to around once per week, but now the it’s used four times a week on average.

The unit decides what to purchase according to demand for the year, while taking into account seasonalities. Every quarter, they contact pharmacists, hospitals, and other health entities to get an idea of what the demand for certain products will be in the coming months. The unit then procures medicines according to this demand, while using demand from previous years to generate an accurate forecast.

Farrugia added that appeals in the tendering process are a major hindrance to securing medicine supplies. “When we have an appeal, it stops us from purchasing and we either have to find an alternative for the patient or speed up the process.”

In the worst case scenario, “with €400 they can stop you from buying the stock”.

Prof. Anthony Serracino Inglott, who leads the Medicine Authority, told the committee that the medicines shortage is a global phenomenon, and that the problem in Malta is almost negligible compared to situations in other countries.

“If we have even one medicine out of stock, it is a sleepless night,” he said.

He reiterated Farrugia’s remark on appeals in the tendering process. “We can’t leave patients without medicines because someone lodged an appeal.”

He also warned that, with the war in Ukraine with Russia, a more troubling situation in the future would be a “war of medicines”.

Brexit posed a big issue for the Medicines Authority too. Helen Vella, the licensing director at the authority, explained that a taskforce was set up within the authority to evaluate the effects of Brexit on its operations.

She explained that Malta is not a valuable market for European medicines suppliers because of its small size. Several companies have even retired their licenses. Nonetheless, Vella said many licenses have been issued through a simplified registration system.

Malta also enjoys an EU derogation with a few other countries allowing government to issue licenses to UK companies until 2024, but only for products they can’t find in the EU market.

Mario Debono, president of the pharmacy sector in the Malta Chamber of SMEs, said this shortage is of Europe’s own making after medicinal companies moved their manufacturing operations to countries like India and China.

“Everyday drugs are made there, or part of them are made there, or the active pharmaceutical ingredient (API) is made there. The ingredient defines the availability of the product.”

He remarked that different authorisation procedures across EU member states is a hindrance for local companies. “If a product is approved in Germany, why shouldn’t it be approved in Malta?”

Debono commented that larger EU countries like Germany, Denmark, France and Italy have resorted to importing medicines from Turkey because prices are cheaper.

“Malta’s always at the end of the line. [Suppliers] first go to more profitable countries, and then consider us.”

Malta Chamber of Commerce President Marisa Xuereb remarked at the end that the local market is small but remains competitive, with lots of distributors and enormous amounts of product licenses.

“This flexibility and competitiveness is making it possible that, while we have shortcomings, they’re transitory, and the gaps are being filled in quickly.”

She agreed that the tendering process should be changed to reflect the international market, while companies who win such tenders need to have visibility on supply. “There should be no situation where whoever imports is the last to know that there’s an extraordinary situation.”