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Rosa Oyarzabal

Rosa Oyarzabal Arigita is an associate in the Life Sciences team. She assists clients across a range of regulatory, legal and procedural matters in the pharmaceutical and food sectors, and her practice focuses on EU and Spanish regulatory advice.

Rosa has acquired significant experience in the pharmaceutical advertising space, both at EU level as well in Member States such as Spain and Belgium. She is also familiar with the EU food and advertising rules, and regularly advises clients in the plant-based sector on these topics. As part of her practice, Rosa also assists clients with the implementation of the Nagoya Protocol and the access and benefit sharing rules of a number of jurisdictions.

Rosa has assisted in multiple litigations in front of the European Court of Justice, including as part of pro bono efforts. For example, Rosa plead in front of the Court of Justice for case C-356/21, concerning the rights of LGBTQIA+ self-employed persons to not be discriminated against when contracting with another party and during the performance of their activities.

On 13 December 2020, Belgium amended its rules regarding compassionate use and medical need programs to confirm that authorized programs can continue to operate after the marketing authorization for the concerned product has been granted but while the decision on reimbursement is still pending.

The Law of 25 March 1964 (“Medicines Law”) regulates the use of medicinal products that have not (yet) received a marketing authorization (“compassionate use”, “CU”) and for off-label use (“medical need”, “MNP”). The Belgian Federal Agency for Medicines and Health Products (“FAMHP”) must grant an authorization to allow the use of medicinal products in a compassionate or medical need context
Continue Reading Belgium Amends Compassionate Use and Medical Need Program Rules to Expand Access

As reported previously on this blog, several member states have imposed bans, requisitioned stock and applied various other control measures on medicines and protective equipment (e.g., Belgium, Bulgaria, the Czech Republic, France, the Netherlands, and Poland). On 8 April 2020, the European Commission (“Commission”) issued Guidelines on the optimal and rational supply of