Clinical research and biomedicine - Medical research using genetic technology and the influence of the Biotechnology Directive - Health law implications of the biotechnology directive
11 important questions on Clinical research and biomedicine - Medical research using genetic technology and the influence of the Biotechnology Directive - Health law implications of the biotechnology directive
What article is important concerning the application of the Directive to gene sequencing?
Can a gene be patented on the basis of art. 5 Directive?
- The simple discovery of elements of the human body (such as DNA) are not patentable
- Gene sequences are only patentable when
- the gene sequence is isolated from the human body by a technical process
- the industrial application of a sequence is disclosed in the patent application
What does article 6 Biotechnology directive explain?
- no patents granted if commercial exploitation would be contrary to ordre public or morality
- Higher grades + faster learning
- Never study anything twice
- 100% sure, 100% understanding
For my 1st exam I got a C. Then, I started looking for ways to learn better and I came across Study Smart. Since then I have scored a A+, A, A- and another A. I highly recommend it to everyone who wants to hear it. I am so happy with it!!
I was struggling to finish all my first-year subjects for 3 years. Then I discovered Study Smart, which helped me to finish all of them within 3 months.
Because of StudySmart, things are going well in many ways. Before, I always had study stress and no time for anything. Now I feel calm and confident (because of the program). I used to score a B, now I usually score an A or A+.
Hey Chris, I really want to thank you very much for developing the platform, I usually got around C for my exams, now I scored an A+, an A and a A- !!
Since using Study Smart, my average has increased significantly. I even completed a statistics course with a A+ while I'm bad at statistics. I took on extra courses this year, because of Study Smart. Thanks so much!
Ever since I started studying with StudySmart I passed all my exams !!! No more re-sits!! At first, I was happy with a pass and now I only get good grades. Many thanks!
I aced all the courses I studied with Study Smart. For law, I first scored a D, and now an A! I’m 100% sure that I’ll pass all the courses I study with Study Smart.
I always thought I studied well. My grades were fine. I could never have imagined that applying these study skills would have such a huge and direct impact on my grades, my speed and the pleasure I have in learning.
For the first time, I finally feel totally confident about the way I learn. I have the perfect overview and make great progress in terms of speed and the grades I get. Thanks, Chris!
I immediately started to enjoy learning again, and my grades soared. All of a sudden, everything went better. I highly recommend Study Smart to all students..
Being able to create my materials online made the process of studying so much smoother and quicker. I no longer have to spend a huge amount of my time on creating my summaries.
At first, my notes were a mess. Now I use Study Smart to take my notes in a perfectly structured way. It helps me to save a lot of time and do other things I enjoy.
Students that study with Study Smart get better grades. The system applies all the learning methods in such a way that both well-performing students and students who struggle perform much better.
Hi Chris, I would like to thank you very much. Last year I scored C on a course, and this year I got an A+ thanks to your method! Thank you very much!
The largest effect is that my child is more enthusiastic about school! Every parent wants their children to be happy at school, Study Smart made it happen.
In high school, I failed several exams, and that has really changed now. I actually needed this tool very much back then. Since I started studying with StudySmart, I haven't had any D's. My average score is now an A and those are results I would have never had in the past
With my old method, I passed only 3 out of 8 courses. Since I started taking my notes digitally in Study Smart, I have passed all my courses on the first try. For me, StudySmart takes away the stress of wondering if I will pass or not.
Thanks to StudySmart, I passed all my exams, and with better grades than before! On top of that, I have mastered a very good study method now, which I am confident will help me earn my degree.
When is sth contrary to ordre public or morality?
- Prohibition in 1 MS is not a determining factor
- CJEU: wide scope for manoeuvre/discretion for the MS
- Broad notions
The Biotechnology Directive gives some examples of practices that are contrary to ordre public of morality. Which ones?
- Germ line gene therapy: not allowed
- somatic cell gene therapy is allowed
- Usage of human embryos for industrial/commercial purposes
- does it also extent to research?
- Process of cloning human beings
Embryonic stem cells are?
- they have the capacity to self renew into any kind of cell
- also into new humans
What question is tackled in the brustle case?
Is there an obligation to informed consent when patenting?
- recital 26: non-binding reference to the concept
- no binding provision stating that the lack of consent makes an invention unpatentable
- would failure to obtain consent by contrary to ordre public or morality?
- consent for
- taking of material?
- filing of the patent application?
The concept of informed consent was not mentioned in the directive, only in the preamble
How is there surveillance of biotechnological research?
- Art. 7 directive: Group on ethics in Science and New technologies
- Obligation of the EC to submit reports to Council and EP about development
What is the task of the Group on Ethics and New technologies?
- Evaluate all ethical aspects of biotechnology
- provides advisory guidance
- doesn't provide authorizations on individual patent applications
There is another case on the patentability of human embryo's, which one? Explain.
- the ICSS seeks patents for a technology that produces tem cell lines using parthenogeneses
- the parthenogenesis does not produce totipotent stem cells, only pluripotent cells
- the UK IP office followed brustle excluding patentability
- ICSS: but the exclusion was only in so far they were capable of producing totipotent cells
CJEU
- pluripotent cells do not have the capacity to develop into a human being
- >< Brussel
- court made a mistake in the brustle case
- so patentability is possible in so far it cannot develop into a human being
The question on the page originate from the summary of the following study material:
- A unique study and practice tool
- Never study anything twice again
- Get the grades you hope for
- 100% sure, 100% understanding
