Team:Groningen/Template/MODULE/PP/FP/COGEM

What are the greatest hurdles on the way to approval for our design as a product, apart from the technological feasibility? We already knew that approval would be needed for use of a Genetically Modified Organism (GMO), but how does this fit into the picture when you use a GMO for medical purposes? In that case, you would have to go through a double approval process, a) drug development, and b) GMO approval. With this in mind, we organised an interview with Frank van der Wilk, secretary of the COGEM, to talk about what he thinks of our product and how he sees its future.

Before a drug is released on the market, the EU places strict regulations on the approval process. Several permits for working with GMO’s exist that each cover a part of the whole process. The first permit that needs to be given is the ‘ingeperkt gebruik’ (contained use) permission. This is usual for all labs working with GMOs. The second permit is given before field trials are held, as there is a chance of modified bacteria being released in the environment. All this needs to be approved by the commission for human research (Commissie Mensgebonden Onderzoek CCMO) as well. When the field trials have shown good results, the permit for market introduction in Europe needs to be acquired. This involves the European Medicine Agency (EMA). Normally, the EMA is not used to use of GMOs, as there are simply not many of these kind of devices on the market yet. However, it is likely that the approval system will be the same for LactoAid as for all new drugs. All in all, drug development can take up to 12 years and involves many steps and stakeholders.

When we asked about social hesitance with GMOs in healthcare, Mr. Van der Wilk replied that we are lucky to work in this sector and not in agriculture. The use of GMOs in agriculture has a bad name, which makes new agriculture products hard to get accepted by the general public. There are not many GMO-medical devices , which may resolve the social acceptance issue.

Although our project has some practical safeguards to prevent the modified bacteria being released into the environment, we also should think of the origin of the genes that are in the ‘machine’. When genes come from a known pathogen, chances are that the product is regarded with a higher risk. When we wanted to incorporate an entirely synthetic gene, it will be near to impossible to get approval for market entry of the product. We are not using synthetic genes, and it appears that most of our genes are from non-pathogens, which is thus a positive point with regards to the approval process of the EMA . It would also be helpful if we could figure out if L. lactis can survive on the skin, or in the bloodstream. If this is the case, it is one less step to go towards complete approval.

When looking at the impact on society, the Commission for Genetic Modification looks at the possible effect of a product and the chances of such an effect happening. Even if there is the slightest risk of a negative side effect, the product will not be approved.

All in all a useful visit!