On November 5, 2025, the Spanish Ministry for Ecological Transition and Demographic Challenge (“MITECO”) adopted a Resolution setting out the National Plan for the control of compliance with access and benefit-sharing (“ABS”) obligations under Regulation 511/2014 implementing the Nagoya Protocol in the European Union.  The National Plan sets out a “risk-based” control system to ensure that life sciences companies in, e.g., the pharmaceutical, plant breeding, cosmetic and other sectors operating in Spain utilize genetic resources (“GRs”) and associated traditional knowledge (“ATK”) in compliance with ABS rules of the country where the GRs and ATK are accessed. We provide more details below.

Building on the existing ABS framework in Spain, and in particular on the Royal Decree 124/2017, the MITECO adopted a National Plan setting out a “risk-based” control system, mandating the competent authorities of the Autonomous Communities (“the authorities”) to perform controls on users of certain sectors that are more likely at risk of utilizing GRs and ATK in violation of ABS rules.  

Purpose and Scope of the ABS controls

The ABS controls will be performed to verify that utilization of GRs and ATK comply with the applicable laws on access and benefit-sharing, including Regulation 511/2014.  For Spanish GRs, controls will verify compliance with the benefit-sharing commitments specified in the access authorization and/or in the mutually agreed terms.

Controls will be performed on “users” established in Spain who utilize GRs or ATK from countries that are members to the Nagoya Protocol, if:

  • The country of origin of the GRs or ATK has adopted ABS access legislation and regulatory requirements; and
  • The access to the GRs or ATK occurred after October 12, 2014 (date of entry into force of Regulation 511/2014).

The National Plan refers to the definitions of Regulation 511/2014.  Thus, “users” of GRs are defined as all natural or legal persons conducting research and development on the genetic and/or biochemical composition of GRs, including through the application of biotechnology.  However, “users” of ATK are all natural or legal persons using traditional knowledge held by an indigenous or local community that is “relevant for the utilization of GRs” and that is as such described in the mutually agreed terms applying to the utilization of GRs.

The National Plan excludes from the scope of controls human GRs and resources governed by specialized international instruments consistent with the Nagoya Protocol such as the Pandemic Influenza Preparedness Framework.

Targeted Controls on “Real Users”

Spanish authorities will target certain sectors, including the pharmaceutical, biotechnology, cosmetic and the research sectors and identify “real users” among these sectors.  The identification of “real users” will occur based on the information available, including prior authorizations to access Spanish GRs, due diligence declarations, information obtained through other controls, and information provided by users.  Authorities will also send a questionnaire to entities identified as “potential users,” and if the responses are “incoherent” or potential users fail to respond, authorities may seek clarifications and prioritize controls on such users.

Once authorities have identified “real users” controls will be performed on those users for which authorities considered that there is a higher risk of non-compliance based on the following criteria:

  • Origin of the GRs or ATK – The National Plan considerstheuse of Spanish genetic resources generally lower risk, while the use of resources from outside Spain, particularly from countries with high perceived corruption, is considered higher risk.  Further, the Plan considers use of GRs from collection not registered in the EU higher risk.
  • Complexity of the utilization chain of the GRs or ATK – According to the National Plan, the risk of non-compliance increases with a number of factors affecting the complexity of the utilization of the GRs or ATK including (i) a higher number of GRs or ATK used; (ii) multiple provider countries; (iii) several stages of utilization (e.g., research followed by commercial development); (iv) access through intermediaries rather than directly; (v) changes of use that trigger ABS obligations after initial access; and (vi) extensive transfers and transactions involving multiple actors.
  • Characteristics of the user – The National Plan allows authorities to consider a variety of characteristics of the user entity, including existence (or absence) of internal ABS policies and procedures, use of EU-recognized best practices, corporate structure, subsidiaries, and internal exchanges of samples, use of subcontractors or service providers, and results of previous inspections.

Notably, the National Plan establishes an order of prioritization for criteria applicable to the initial phase of its implementation and sets out a list of “non-cumulative” criteria that competent authorities are required to apply.  We understand this to mean that the prioritization criteria are to be applied on an alternative, rather than cumulative, basis.  The criteria include:

  • Whether GRs or ATK have been accessed within the last five years in countries with a high corruption perception;
  • The number of GRs or ATK used within the last five years;
  • The number of provider countries from which GRs or ATK have been accessed within the last five years;
  • Whether GRs or ATK have been accessed through third-party collections that are not registered in the EU; and
  • The number of subcontractors or service providers relied upon by the user within the last five years.

Controls triggered by third-party concerns

Controls may also be triggered by justified concerns (“reservas fundamentadas”) supported by evidence or credible indications of non-compliance from (i) provider countries, (ii) Spanish authorities, (iii) EU working groups, (iv) international organizations (e.g., INTERPOL, third countries’ official agencies, NGOs), and (v) recognized national entities.

Practical Implications

Entities established in Spain or with Spanish subsidiaries, operating in the targeted sectors should review their ABS compliance status, especially where the GRs and/or ATK are accessed outside Spain or through complex supply chains, and ensure compliance with the applicable requirements of the access country.

Covington has assisted numerous life sciences clients in similar inspections across the EU and beyond.  These inspections tend to follow a common playbook.  If your company receives a questionnaire from the Spanish authorities, you will likely be expected to respond within 30 days.  The survey will request an overview of your R&D involving GRs and/or ATK.  Your response should be timely, accurate, consistent, and supported by clear documentation.  Incomplete, inconsistent, or unclear information may increase the likelihood of follow-up inquiries and inspections.  Our team stands ready to assist.

If you have any questions, do not hesitate to reach out to Bart Van Vooren (bvanvooren@cov.com) or Max Jerman (MJerman@cov.com)

Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren, partner leads a dynamic practice at the intersection of EU regulatory law, global health, and biodiversity law. In these fields, he advises innovative pharmaceutical, food, cosmetic and technology companies on complex EU and global regulatory, compliance and policy assignments.

Bart…

Bart Van Vooren, partner leads a dynamic practice at the intersection of EU regulatory law, global health, and biodiversity law. In these fields, he advises innovative pharmaceutical, food, cosmetic and technology companies on complex EU and global regulatory, compliance and policy assignments.

Bart holds a Ph.D. in EU and International Law and was a professor of EU law until 2013. During that time, he wrote the first-ever handbook with Cambridge University Press on “EU External Relations Law” (2014). He then transitioned to private practice, and frequently acted for the Belgian government before the EU Court of Justice (e.g. C-16/16P Belgium vs Commission). Bart joined Covington in 2016, leading some of our most consequential EU litigation proceedings (e.g. C-311/18 “Schrems II”) over the years.  Having handled nearly 50 cases before the EU Court, he’s uniquely qualified to support our corporate clients in our most high-stakes disputes. Recent examples include T-189/21 Aloe Vera of Europe v Commission (which we won, so the Commission decided to appeal); as well as T-201/21 Covington & Burling and Van Vooren v Commission (which we also won, and hence is also on appeal).

As a pioneer in biodiversity law, over the past 15 years Bart has built a unique, global practice on Access and Benefit-Sharing (ABS) laws under the Convention on Biological Diversity, the Nagoya Protocol, the Plant Treaty, the High Seas Treaty and the WHO Pandemic Agreement. ABS compliance is critical when sourcing biological materials for life sciences R&D and I work with many of the world’s innovative life sciences companies on the whole range of e.g. transactional, contractual, compliance, IP, (EU) regulatory and litigation work relating to ABS. As biodiversity has increasingly become identified as a major commercial and financial risk to companies, so has the practice expanded to e.g. biodiversity credit markets, biodiversity insurance, biodiversity claims and advertising, and so on. Since April 2025, Bart has been appointed as the industry representative to the Steering Committee of the UN Biodiversity Fund that seeks funding from the private sector for biodiversity conservation and restoration.

Bart also pioneered our global health practice. He has advised pharmaceutical clients on seasonal and pandemic influenza since 2016. Since then, this practice area expanded to cover all matters relating to infectious diseases, and as of 2020, emergency preparedness and response (eg. WHO prequalification, International Coordination Group negotiations, Emergency Use Listing, International Health Regulations Rev 2024). He has been the pharmaceutical industry’s lead lawyer advising on the WHO Pandemic Treaty negotiations, adopted on 14 May 2025. Currently, he continues to advise on the work of the Intergovernmental Working Group (“IGWG”) teasing out the technical details of the “Pathogen Access and Benefit-Sharing System” intended to create legally binding obligations on companies to commit vaccines, therapeutics and diagnostics in case of a new global health emergency.

In Chambers rankings, clients have kindly described Bart as “very knowledgeable, action-focused and service-focused lawyer”, adding that he “really tries to find a way of working through challenges”, am “customer-oriented” and provide “sound advice and reasonable options for our business with pros and cons.”

Finally, Bart has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation before the EU Court.

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Photo of Max Jerman Max Jerman

Max Jerman is an associate in the Life Sciences Practice group. Max advises clients across a wide range of regulatory and compliance issues in the pharmaceutical, food, and cosmetics sectors, with a focus on EU and Italian regulatory advice. He is a native…

Max Jerman is an associate in the Life Sciences Practice group. Max advises clients across a wide range of regulatory and compliance issues in the pharmaceutical, food, and cosmetics sectors, with a focus on EU and Italian regulatory advice. He is a native Italian and Slovenian speaker.

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