Laws and regulation
Report regarding Bioproduction of Thepatical uses proteins
As a part of our Human Practises collaboration, we asked the Jurist of the Evry/Paris-Saclay team,
Maxime de la Fouchardière, to help us about the legal issues that could come with the production of
recombinant proteins in France and in general in the EU.
Studying and producing proteins for the research.
Our first question was about the production of recombinant proteins for the research purposes, would it create any issues. Maxime told us that research in France and moreover in Europe know actually very few regulations regarding the act in itself or its subject. This freedom is guaranteed by the French Code of Research. Besides this legal freedom, there are strong regulations regarding biomedicals studies, if they are conducted on animals or on human beings. Nevertheless, if GMO in research is authorized, their use and their deliberate release are strictly set by the French Environment Code. It means for us, that we can use and produce recombinant proteins as long as the GMO we use to produce them is safely kept.
But let’s not forget that our project is to produce recombinant proteins for human therapeutic use. Maxime then explained to us that in France the drug market is tightly controlled by the French Agency for Drugs Safety, the ANSM. According to the Fench Public Health Code, is considered as a drug every substance that is said to have any curative or preventive properties. To be authorized, a drug candidate must go through the Drug Marketing Authorization process or AMM in France. This a difficult procedure where the drug needs to fulfil precise criteria: it must have a favourable risk- benefit balance, have a therapeutic effect and have the same composition as the one registered in the application form. It must go through several phases of test on animals and humans where a lot of data will be gathered to provide the right information on the well-used of the drug.
This whole process can take up to 10 years and costs billions of euros.
However, it exists few case where a drug can be sold with no AMM:
The Temporary Authorization of Use (ATU): if a drug doesn’t have any AMM and has significant positive result in the clinical trials, doctors can be authorized to prescribe the drug. But this is only possible if the disease concerned is sufficiently rare or severe.
The Temporary Recommendation of Use (RTU): grant the possibility for a doctor to prescribe a drug if there is no other possibility of treatments, with conditions ruled by the ANSM
Doing further analyse on how our box and the protein It produces could be used in the market, we thought that we could produce protein or hormone used in the livestock industry.
Maxime has then given us insight on how such molecules could be authorized: In France, and on the European scale, the companies that want to sell a new molecule on the European market, must get their products assess buy the European Food Safety Agency (ENSA). They will go through a process where they must produce a study the risk of their molecule, and the result will be analyzed by the ENSA, which will allow the molecule if it doesn’t present any harmful effect for the human and animal health and doesn’t show any unacceptable risk for the environment. If allowed the molecule will be registered in the list of authorized molecules. To be then authorized in France the molecule will be analyzed by the French regulating agency for food and sanitary security (ANSES). The ANSES will verify if the molecule registered has the right composition, and basically, do a similar work as the ENSA.
This whole process is much shorter than the AMM and can take up to 3 to 5 years.
The survey reached thirty students from different teams and from several countries. The majority of participants come from academia (53.33%) and industry (30.00%).
Overall, this study shows a very positive opinion on biomanufacturing. Indeed, even if more than half of students do not feel sufficiently informed or trained on biomanufactring, the vast majority of students think that biomanufacturing presents a sustainable alternative to traditional manufacturing techniques. The survey reveals that most of the participants value that, with further research, biomanufacturing technologies will outperform traditional manufacturing techniques in terms of financial efficiency.
Though, many students deplore the facts that the connection between academia and industry in biomanufacturing research is still pretty weak and that negative public perception deters investment in biomanufacturing.
When analyzing these data, you should keep in mind that all respondents participate in iGEM competition, which suggests that these people have an opinion that is already favorable to biomanufacturing, compared to students as a whole or the general population.