Linda McAvan, a member of EP’s Public Health Committee, tells EuroparlTV which lessons the EU should draw from the PIP breast implant scandal.

Interview: Europe to act on implants

https://api.multimedia.europarl.europa.eu/documents/20125/15833236/n003-0168-en_mf.srt

Linda McAvan, hello.  You were instrumental

in introducing new laws  on medicine safety here in Europe.

What do you think of this enormous  scandal over breast implants

I think a lot of people will be shocked,  as I have been,

to see the way that medical devices are  currently put on the market and regulated,

and that there are not such stringent  checks as we have on medicines.

Are you satisfied with  what the Commission proposed?

Well, firstly, in France  it's clear there was a fraud.

We need better inspection regimes,  but they must be unannounced.

It's nonsense to give 10 days' notice  of a visit to a company.

We asked for and got assurances  that this will change in the new law

and there will be  unannounced inspections.

The second thing is  the lack of traceability.

So they don't even know  whether they have the bad implants.

No. Many private clinics  haven't kept records.

We don't know who has had what implants.  They will have a serial number.

We also want a register kept  of who has what implant.

There's no point in a serial number  if doctors don't keep a register.

The Commission said maybe,  but I think it's essential.

The EP asked for this 10 years ago  when they did the current law.

But ministers from various countries said  it wasn't needed, it was over-regulation.

Now we find that thousands of women  are worried they may have these implants

and we can't tell them yes or no.  It's really not acceptable.

One major aspect of the scandal is that  the French authorities had been warned

saying, 'This seems to be a sub-standard  product.' But nothing was done.

our European Medicines Agency equivalent,

went to France in 2000,  looked at the implants,

didn't like what it saw  and banned them from the US.

But there was no mechanism for  informing European authorities,

or even French authorities,  that they had been there.

We must have more  international cooperation.

We want an alert system in Europe and  with our partners elsewhere in the world.

The problem is that decisions about  whether or not governments will pay

for implants to be removed...  -Very unclear in many countries.

This is not subject to  European Union law.

so that must be taken to  national parliamentarians and ministers.

But we need a big public debate  about the whole implant industry.

There's national legislation,  but it's a pan-European issue.

In almost all countries, especially the UK,  France, Germany, women are affected.

Could they come to the Petitions  Committee, for example, in the EP

Or hasn't Europe advanced so much  as to be able to help them?

They can bring forward their case  in areas where the EU has power.

It's like cases of property law when people  buy an apartment in another country

and it goes wrong. That comes under  the national law of the country.

The EP can't dictate what happens there.

What we can do is make the changes  in the legislation that I said

All that has not been looked at at all  by Europe so far?

It has been looked at. We do have laws  and we do have safety standards.

We do have good communications  to a certain level.

When the French found  there was a problem,

the UK authorities knew the next day  and they issued a warning the next day.

The Commission found out about it  in January.

By the end of January  they'll have a report.

Already they're saying,  'We need to change the law.'

It wasn't lack of regulation.  It was a deliberate criminal fraud.

When will inspections be unannounced?  Two or three years? How long will it take?

The new law should be on the table,  they say, in March. Before June, certainly.

I think we can... It depends if we can  make a first reading agreement.

I think governments will be much more  open to European-level coordination.

So I think we'll see a new law  hopefully within a year

and it takes about six months  to come into force.