The “Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity” is an international agreement which aims at sharing the benefits arising from the utilization of genetic resources in a fair and equitable way. It entered into force on 12 October 2014.

The Nagoya Protocol imposes a complex set of multi-jurisdictional compliance obligations on businesses active in the pharmaceutical, food, cosmetics and other life science sectors. It now has more than 100 contracting parties, including the EU. The key legal source in the EU is Regulation (EU) No. 511/2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union.

The Protocol consists of three pillars. First, countries may require that a company seeking access to any material of plant, animal, microbial or other biological origin (“genetic resources”), receives a government authorization before acquiring it. Second, those countries may also impose conditions for “equitable benefit-sharing.” For example, they may require that a percentage of the profits from resulting products are paid to a public fund in that country (e.g. South Africa). Countries that impose such access and benefit-sharing (“ABS”) conditions are called provider countries. Third, all 100+ parties to the Nagoya Protocol must enforce compliance with the ABS-requirements of the provider countries. These are called “user countries.”

Germany has also signed the Nagoya Protocol and enacted national legislation to implement the obligations under the Nagoya Protocol and under the Regulation (EU) 511/2014. Based on this law, the German Federal Agency for Nature Conservation (Bundesamt für Naturschutz) as the competent authority has recently taken regulatory steps to further implement and enforce the Nagoya Protocol. As such, the competent authority has now started specific outreach to pharmaceutical companies in Germany and requests detailed information about the companies’ measures taken to ensure compliance with the Nagoya Protocol. The German authority, among other things, also asks whether the companies have accessed genetic resources since October 2014 and whether they have developed a product based on the use of genetic resources. Companies are obliged to respond to these requests for information. Violations of the Nagoya Protocol obligations may be subject to regulatory fines.

On 9 May 2018, the German authority has also issued a general decree and requests all recipients of research funding involving the utilization of genetic resources and traditional knowledge associated with genetic resources to declare that they exercise due diligence in accordance with the laws implementing the Nagoya Protocol (diligence declaration).

The Nagoya Protocol is a compliance challenge for many companies. Especially, pharmaceutical and biotech companies can fall under these rules. Therefore, whenever the company’s business requires R&D on material of biological origin, it is worth examining whether there are obligations under the Nagoya Protocol.

In conclusion, pharmaceutical and other life sciences companies as well as companies in the food and cosmetics sector will need to review their R&D activities and consider implementing measures to consider and to comply with the Nagoya Protocol. If a company finds that Nagoya Protocol obligations are triggered, they may need to request public permits and negotiate benefit-sharing as required in the country of origin of the genetic resources. Companies also need to implement internal compliance measures to meet the legal requirements in the EU. The German regulatory agency has started reviewing these measures and it is likely that it will also enforce against any non-compliance.

Covington has a unique practice focusing on compliance with the Nagoya Protocol, embedded within its global life sciences practice. Our experience covers more than 20 countries in four continents, including Germany.

Source:

General Decree of the German Federal Agency for Nature Conservation (Bundesamt für Naturschutz), Federal Gazette of Germany dated 9 May 2018.

Link to Decree:

https://www.bundesanzeiger.de/ebanzwww/wexsservlet?session.sessionid=93250e469fb2b796fd90a075b1dc53bc&page.navid=detailsearchlisttodetailsearchdetail&fts_search_list.selected=6bcfeee881f585c6&fts_search_list.destHistoryId=07617

 

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Photo of Dr. Dr. Adem Koyuncu Dr. Dr. Adem Koyuncu

Adem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & Device” practice group and also a member of our Compliance practice. Adem is…

Adem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & Device” practice group and also a member of our Compliance practice. Adem is recognized as a “leading lawyer for pharma and medical devices law” (JUVE 2021).

Adem helps clients on a wide range of EU and German law issues, including regulatory, compliance, privacy and liability matters. He also provides strategic advice. He knows the life sciences sector also from his earlier work in the pharmaceutical industry and as a medical doctor. He represents clients before courts and authorities and assists them in contract negotiations, investigations and transactions. For years, Adem is listed in various lawyer rankings.

See some Accolades from Clients and Surveys:

  • “He is one of the most detail-oriented and client-focused partners I have ever encountered.” (Client, Chambers 2021)
  • „Great professional and human competence, good team player.“ (Client/Adverse Party, JUVE 2022)
  • “I find him to be one of the most pragmatic regulatory lawyers. He was a doctor before a lawyer, has been in-house, worked on lots of stuff that I have to handle in-house, which helps when getting advice. He is really good at saying it’s a complex situation and your best option is to do this.” (Chambers 2022)
  • “He always comes through with extremely helpful advice. He brings a unique understanding and experience to his practice as both a lawyer and medical doctor.” (Chambers 2021)
  • “Adem Koyuncu is not only a lawyer but also a doctor and has worked in industry. He knows the perspectives that also move in-house lawyers.” (Legal 500 2022)
  • “He is very sharp and quick, while at the same time having a good sense of humor and nerves of steel. Very pleasant to work with.” (Legal 500 2022)
  • He is described as “versatile competent, reliable and high quality” (JUVE 2021) and “incredibly fast.” (JUVE 2018)
  • Provides advice at “an outstanding level.” (Legal 500 2015)
  • “Very strong negotiation skills.” (JUVE 2011)
  • Clients appreciate his “very broad knowledge and long-standing expertise” (JUVE 2021/22) and that “he is approachable, knowledgeable and really easy to talk to over the various issues. He is calm and has seen most problems before.” (Chambers 2020)
  • Peer lawyers described him as “highly competent” and a “very good and pleasant lawyer” (JUVE 2014) and as “the off-label-guru, substantively very good, creative.“ (JUVE 2022)

Adem is the author of numerous publications (e.g., in leading books on pharma law, product liability and clinical trials) and frequent speaker at different events. As such, he will soon speak at following events:

  • “Medical Device Liability and Risk Transfer 2.0 | A liability issue for the Management?!,” BVMed, Webinar (3/24/2023)
  • “Data Protection Requirements and Open Issues in the Pharma Sector – Status quo,” Speech at conference, 26. Marburger Gespräche zum Pharmarecht, Marburg (3/16/2023)
  • “Vendor Oversight & Vendor (Quality) Management in the Pharma Industry,” FORUM-Institut, Online Seminar (4/19/2023)
Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive…

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive litigation experience before the EU Court of Justice in dozens of cases.

Over the past seven years, Mr. Van Vooren has developed a niche practice on compliance with the Biodiversity Convention and the Nagoya Protocol, a set of rules to combat bio-piracy worldwide. He has accumulated unique, practical experience in dozens of jurisdictions around the world, and has handled everything from benefit-sharing negotiations, over compliance programs, to inspections by authorities.

Finally, Mr. Van Vooren has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation.