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Roderick Dirkzwager

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a co-lead of the LGBT+ Affinity Group in London.

With a broad life sciences practice, Roderick regularly advises on:

  • EU, Irish, and UK regulatory issues relating to pharmaceutical products, medical devices and consumer products;
  • commercial agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, distribution arrangements and manufacturing and supply contracts;
  • regulatory and commercial due diligence for life sciences transactions; and
  • intellectual property issues arising in corporate transactions and IP-related contracts.

Prior to joining the firm, Roderick completed his Ph.D. in Biochemistry, focusing on the development of novel, low-cost malaria diagnostic technologies using DNA aptamers.

Last week (28 March 2024), the UK Health Research Authority (“HRA”) published a draft model investigator-initiated study agreement (“mIIS-CTA”) to govern investigator-initiated clinical studies (“IIS”) that involve NHS patients and receive support from commercial partners.  The HRA is calling for comments on the draft mIIS-CTA by 13 May 2024.Continue Reading UK HRA Consults on a New Model Investigator-Initiated Study Agreement

On 26 January 2024, the European Medicines Agency (EMA) announced that it has received a €10 million grant from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA). Although still in its early stages as an agency, AMA shows significant promise to

Supplementary Protection Certificates (SPCs) are a form of patent term extension right that are available in the EU for medicinal products.

Tune into this episode of Covington’s Life Sciences Audiocast where Inga Pietsch and Roderick Dirkzwager discuss some of the developments in SPC case law from the European Court of Justice in relation to the

The EU Clinical Trials Regulation 536/2014 significantly expanded the transparency requirements for clinical trials in the EU, resulting in the public availability of most documents and information submitted by sponsors to the new EU Clinical Trial Information System. Tune into this episode of Covington’s Life Sciences Audiocast, where Robin Blaney and Roderick Dirkzwager look

On April 27, 2023 the European Commission (“Commission”) released its proposal to introduce a single procedure for the granting of Supplementary Protection Certificates (“SPCs”) throughout the EU.  The changes are intended to complement the new unitary patent procedure that will enter into force on June 1, 2023.  The Commission intends the new unitary SPC to

The latest draft pharmaceutical legislation published by the European Commission (“Commission”) is set to shake up the regulatory exclusivity protections available to innovator pharmaceutical companies operating in the EU (as discussed in further in our previous blog). As part of these developments, the Commission has clarified the concept of the Bolar exemption

The EU’s latest draft pharmaceutical legislation contains some interesting developments on transparency matters, both in relation to access to documents and transparency around the funding of research and development of medicinal products.

1. Draft Regulation – Further Clarity Regarding Public Access to Documents

Disclosure of documents in response to an access request under the EU

The European Commission has proposed specific measures to increase the supervision and monitoring of the use of antimicrobial medicinal products (or “antimicrobials”), with the aim to counter the spread of antimicrobial resistance (“AMR”).  At the same time, the measures are also aimed at promoting and incentivizing the development of new priority antimicrobials through the use

As part of its policy goal of promoting innovation, the Commission’s proposed Regulation creates the concept of a “regulatory sandbox.” If the concept survives the legislative process, the sandbox will be a structured, regulated and time-limited environment in which innovative technologies, products, services or approaches might be tested in a “real world environment,” subject to

On 26 April 2023, the European Commission published its long awaited proposal to revise the EU pharmaceutical legislation.  The proposal includes a new draft Regulation, which will repeal Regulation (EC) No 726/2004, the Orphan Medicines Regulation 141/2000 and the Paediatric Regulation 1901/2006.

As expected, the draft Regulation significantly shakes up incentives available to the