Medicine shortages is an increasing problem in many countries, also Norway. Small countries with small markets are hit harder than bigger countries with bigger markets. So far in 2019 the Norwegian Medicines Agency has recieved 1035 messages of shortages in Norway. Medicine shortages can occur for many reasons, such as manufacturing or distribution difficulties or problems affecting the quality of medicines that can impact on patient care. The reasons are complex and linked to the fact that the medicinal product's market and the distribution chains are global. Medicine shortages are primarily caused by circumstance outside Norway, often outside the EU. In the EU, medicine shortages are dealt with at national level by national competent authorities. However, national authorities can not take acction against manufactureres abroad even though they often are responsable for circumstances leading to medicine shortages. The only real possibility for national authorities to prevent or relieve medicine shortages is to impose measures on national market operators, such as wholesale distributors. The suggsted amendments are justifiable as appropriate, necessary and proportionate to protect the life and health of humans by preventing the occurrence of shortages of medicines.

The Ministry of Health and Care Services proposes amendments to the Act on Medicinal Products to prevent or relieve shortages.