life science

CJEU on transparency of medicine registration data

On 5 February 2018 the CJEU issued long-awaited judgments in three cases in one day concerning release to third parties of medicinal product registration documentation. These rulings confirm the European Medicines Agency’s current data transparency policy. How are conflicting interests weighed regarding release of medicine registration data?

Medical data—keep or delete?

From 25 May 2018 Polish healthcare institutions will face conflicting rules on how to handle medical documentation under the EU’s General Data Protection Regulation and Polish healthcare laws. The inconsistencies could be eliminated by the new Personal Data Protection Act, but it appears unlikely that work on the new act will end on time. So what should institutions do to limit their regulatory risk?

I know what I’m drinking – Polish version

Consultations have ended on a draft amendment of the Act on Sobriety Education and Countering of Alcoholism as well as the Food Safety and Nutrition Act. They are to raise the awareness of consumers and help them make informed choices, now in relation to alcoholic beverages.

Who must conclude a written contract for supply of agricultural products?

Long-awaited regulations limiting the scope of the duty to conclude written contracts for supply of agricultural products went into force on 22 August 2017. Under the new rules, the requirement for written contracts applies only to supplies of defined groups of agricultural products from farmers operating in Poland.

Pharmacies for pharmacists—but what about patients?

The amendment to the Pharmaceutical Law adopted under the slogan “pharmacies for pharmacists” entered into force on 25 June 2017. What are the strict regulations supposed to protect pharmacists against: a shortage of customers, or excessive expansion of their own business? How will this amendment function, and is there another one ahead under the slogan “pharmacies for patients”?

Green light for self-regulation of the drinks industry

In March 2017 the European Commission published a report on labelling of alcoholic beverages. It seems the exemption allowing alcohol producers to avoid placement of information on the ingredients and nutritional value of their drinks is drawing to an end. The beer, wine and spirits industry has 12 months to propose solutions to the Commission reflecting the specific nature of alcoholic beverages but also ensuring effective protection of consumers throughout the European Union.