As part of our project development, we researched the different regulations and directives that could be applied to our project, as a Recombinant Live Biotherapeutic Product (LBP), and despite our best efforts, we were surprised over the lack of information covering this topic. This made us realise that we would not be able to gather and map all the regulations related to our project on our own.
For this reason, we decided to get in contact with Erik Forsse, a senior adviser (specialist) at the Director’s Office at Karolinska Institutet, who works with investigations, analyses and the processing of in-coming public consultations. He explained that the current regulations for a project like ours does not exist, and inspire us to create a policy of our own.
Even with the support and knowledge that Erik had provided us, we understood that we needed to contact someone working with more in-depth knowledge about regulations. We contacted Katarina Mercer, Senior Advisor for Clinical Development & Regulatory Affairs at Scandinavian Development Services. She, once again, confirmed that there are no available regulations for our project. Katarina supported us in how we could develop our own policy by guiding us through similar cases and by providing us an insight in product development and what strategies we could use.
Additionally, we reached out to the Medical Products Agency (Swedish: Läkemedelsverket), the government agency in Sweden responsible for regulation and surveillance of the development, manufacturing and sales of medicinal drugs, medical devices and cosmetics. We talked to Åsa Kumlin Howell, international coordinator at the medical products agency, and she stated.
“This has been shown to be a hard question to answer, and after some research I haven't been able to find any legislation that regulates live biotherapeutic bacteria.”
From these meetings we were able to determine our strategy for the policy we were aiming to create. The first part of the policy is an introduction to all current regulations regarding GMOs, live biotherapeutic product (LBP) and drug delivery systems as a first step to understanding how all these parts are perceived to-date. Further on, all the background information was analysed and a solution is proposed that assures the safety in the usage of LBP’s. The developed solution proposes an evaluation of Human Safety, Environmental Safety and risk assessment before any product with these characteristics can be approved for human use. Additionally, several final considerations on how clinical studies should be performed are also explained.
Together with the advices from Katarina, Åsa and Erik, we also incorporated the society's views on GMOs into our policy. For this reason, we thought it would be a good idea to host a GMO debate, where we would bring experts with different knowledge and opinions about the use of GMOs and initiate a discussion where the public could actively be engaged and build on an opinion on the subject. This event was held in collaboration with Uppsala University's iGEM team. The result of the panel discussion exceeded our expectations and was implemented into our policy.
However, we wanted to take the next step in the successful implementation of the policy we had been working on. Because of this, we handed the policy over to the Medical Products Agency, since they are the head governmental agency handling, regulating and in the end accepting new medicinal drugs in Sweden. Our goal is that in the future they use the policy we developed for the evaluation of future applications.