Portugal Latest EU Member State to Tackle Medicine Shortages and Regulate Parallel Trade in Medicines

• 23/08/2019
• Articles

In Portugal, an amending decree-law of 16 August 2019 which entered into force on 19 August 2019 seeks to strengthen access to medicines by reinforcing the public service obligation of the various stakeholders in the supply chain. That obligation involves the duty to ensure a continuous supply of medicines. It prohibits abusive or discriminatory practices such as directly or indirectly refusing to fulfill medicine orders or applying differing deadlines.

The new decree-law reinforces the public-service obligations for pharmaceutical companies to ensure that medicines make it to wholesalers who have a duty of their own to supply pharmacies and other retailers. Those who hold a marketing authorisation must constantly monitor their stock positions and communicate possible shortages both to the other stakeholders and Infarmed, the Portuguese health agency.

The decree-law also clarifies the dual role of wholesalers which have to (i) supply the domestic market; and (ii) operate as logistical service providers.

Furthermore, the new decree-law makes an attempt to limit parallel trade by precluding wholesalers from selling medicines to other countries or other distributors, unless they have first made sure to supply the domestic market.

Finally, the amendments bolster the ability of Infarmed to enforce the new rules.

A communication which Infarmed issued to publicize the new rules is attached.

Portugal thus becomes the latest EU member state to tackle medicine shortages and interfere with parallel trade in medicines. It is expected that the new European Commission which will start operations at the end of the year will also address this issue.