As draft EU rules aim to encourage life-saving research and protect patients' rights, EPTV investigates cutting-edge artificial heart and medicine trials in Belgium.

Reporter: Clinical trials - more transparency?

'2,000 died in clinical trials  in four years.'

'80 clinical trial deaths in seven years.'

'How drugs companies exploit illiterate  and poorly-informed guinea pigs in India.'

The European Union wants more  trustworthy testing in its territory.

In this Brussels hospital, this cardiac  surgeon could soon be testing

the first 100% artificial hearts in humans.

but authorisation for clinical trials  in France

takes much longer to obtain  than in Belgium.

I would really contemplate  going where the regulations are easy.

You can't kill innovation  because of too much regulation.

and if you superimpose layers  and layers and layers of regulations,

And then all this innovation drifts away  to emerging countries.

Between 2007 and 2011 the number of  clinical trials in Europe fell by 25%.

Some blame a 2001 European directive  for increased bureaucracy.

New EU legislation could standardise  and simplify these clinical trials,

Often to get a marketing authorisation,  drugs companies have to do clinical trials

in several states. They are  multi-centre multinational trials.

And they had to deal with different rules  in different countries.

Some countries gave an authorisation  in 50 days, others in one year.

In Belgium, it takes around 20 days  to get the authorisation.

It's based, among other things,  on the ethical aspect of the trial,

Here in this teaching hospital in Brussels,  Dr Melot chairs an ethics committee

Together they analyse the scientific,  legal and moral aspects of the trial.

We can't choose  so-called vulnerable groups,

people who are bound to be influenced  by what is being proposed.

They have to accept because  there's such a strong conflict of interest...

Like a prisoner  whose sentence will be reduced,

a homeless person who will be given  free board and lodging,

or a medical student who will take part  in a study developed by their professor.

Once the study is started,  in comes the participant.

This is Xavier who suffers  from the hepatitis C virus.

His doctor offers him an alternative  treatment to that already on the market.

which has the advantage  of including new innovative treatments,

which should increase your chances  of eradicating the virus.

They also potentially  have fewer side effects.

But these are drugs which are  not yet approved for the market

either by the European Union  or the FDA in the USA.

In my case, the duration and the chance  of success were very attractive.

Also, from another viewpoint, taking part  in the development of products,

and even millions of people  in Europe and the world

The participant's informed consent  is essential from the ethical point of view.

It's important that a patient  in a clinical study

that might arise  from taking part in the study,

thirdly, the confidentiality of their data,

and, fourthly, their rights,  and also what is expected of the patient,

their obligations  in terms of compulsory attendance, etc.

After giving consent, the patient is subject  to a series of tests depending on the trial.

They will be repeated throughout the trial  to evaluate its evolution.

Until now the industry was not obliged  to publish trial results in their entirety,

which left some doubt as to  the real side effects of a drug.

It's shocking, yes,  but it's always been like that.

is that from now on all clinical trials,  whether positive or negative,

will have their results published  on the website,

the famous European Union portal,  which is considerable progress.

That makes for people to have trust  in science and it makes for good science.

So all these results  will have to be published.

and you don't know there is one  if results aren't published.

A few corridors further on  in the same hospital,

a team from the drugs company Pfizer  carries out its own clinical trials

will not necessarily want to share data  which are commercially sensitive.

That means that we've done  a whole lot of work...

After all that work and all that expense

we won't share it immediately  with our competitors.

If the new regulation is adopted,  all clinical tests and results,

whether commercial or scientific,  targeted to volunteers or patients,

will be listed  on this single European portal.