Mrs. Linda McAvan,
member of the European parliament (MEP),
Labour party, Yorkshire, United Kingdom of Great Britain and Northern Ireland,
rapporteur in (or to) the said parliament
on the new European Union (EU) proposal of directive
on pharmaco-vigilance on human medication
(and another report by Mrs McAvan on pharmaco-vigilance directive 2001/83/EEC)
made this week, on Tuesday 21 September 2010 or so, a speech in or to the said parliament.

The video of the speech is available here (1):
New law to report adverse effects of medicines
21 September 2010
http://news.bbc.co.uk/democracylive/hi/europe/newsid_9016000/9016588.stm

Here’s my transcript of the gist of the speech. Please don’t interpret this transcript as accurate. I have transcribed to the least bad of my inabilities, but I cannot guarantee anything. If my transcript is however not too bad, please feel free to draw my attention to its main errors. Yes, in a couple of days the EU should have the text in the Official Journal or so.

My comments should follow in another post in a couple of days. Basic imbecilities are however already pointed in this transcript between [ & ] 
Of course when I point between [ & ] to an inadequacy of my understanding of the English language, this refers to my own imbecility – thalidomide-induced brain damage.

Now that I’m here, here’s an existing comment of mine:
http://www.tampabay.com/opinion/editorials/dr-frances-oldham-kelsey-shows-the-good-that-government-can-do/1123407#comments
This week, the European Union (EU) introduced legislation, a so-called pharmaco-vigilance directive, to prevent another thalidomide scandal, i.e., the intentional creation by guv’mint of thalidomide monsters like myself.
Pharmaco-vigilance, that’s vigilance against guv’mints intentionally allowing harmful drugs on the market.
The EU parliament argues that we need protection against unsafe drugs and concludes that only guv’mint can provide this protection. The parliament does not show how guv’mint could possibly provide this protection.
Here’s the BBC:
New law to report adverse effects of medicines
21 September 2010
http://news.bbc.co.uk/democracylive/hi/europe/newsid_9016000/9016588.stm
SNIP
MEPs {Members of European Parliament] have given their backing to a tougher rules to increase the amount of information about side effects of medicines.
The so-called Pharmacovigilance directive has already been agreed by the Council of Ministers and the European Parliament’s Public Health Committee.

Here goes McAvan:

Thank You, Mr. President,

I am sure everybody in this room has taken or is taking pharmaceutical products at some time or other.

The safety of those products is of paramount importance for public health.

THALIDOMIDE

Last week, at a meeting of “experts” to talk about this new legislation, we were reminded that 2010 marks the 50th anniversary of thalidomide [Ivo: that’s not true. Thalidomide was marketed since 1957.]

Anybody my age will certainly remember what thalidomide meant. The IMAGES [Ivo’s emphasis] of children born with no limbs.
[Ivo: McAvan was thus at least 14 years old fifty years ago when those images appeared. So now she’s at least (14 + 50 =) 64 years old. She does not look like that.)

Lessons were learnt from that experience (the thalidomide experience) and over the years, governments developed pharmaco-vigilant systems to monitor the safety of medicines because it became clear that clinical trials alone would never be enough to ensure that once we put medicines out there into the public domain, we would know all the side-effects in advance.

Improvements have been made and last week, "experts" told us that with the improvements we have already made, it would have taken only a handful cases of thalidomide to actually identify the problem.

In the 1960-ies, it took 2000 cases before the problem was picked up. {Ivo: Where did she get that information? From the "experts"?]

In recent years in Europe, we have been working at European level to develop a coherent system between member-states and the European Medicines Agency in London on pharmaco-vigilance.

It is very clear that we need to work together, because with a pool of 500 million people, it is much easier and quicker to pick up an adverse reaction than when working alone at national level.

The creation of a medicines agency, a network of agencies in each country, underpinned by EU law, have helped us to make such progress and the practical tools we created, like the EU database, Eudravigilance, the biggest in the world, helps us to reduce the amount of time to identify adverse reactions.

We need further improvements and since thalidomide in the 1960-ies we have seen problems with drugs like Vioxx and very recently, with the diabetes drug Avandia.

I believe that the package of laws that MEPs and the council have agreed, have negotiated in their first reading, put to this house tomorrow is a very good package which will further improve pharmaco-vigilance in the European Union.

THE PRAC

The creation of the PRAC, the Pharmaco-Vigilance Risk Assessment Committee, is one of the key changes of the legislation.
The PRAC will include “experts”, not just of national governments, but also of patients and healthcare professionals.
It is thus a beefed-up committee which settles [and here, in this sentence, which in fact includes also the two previous sentences, Ivo’s English is not good enough to understand McAvan completely] or takes medicine-safety decisions on the basis of the approval of the medicines by its  “experts”.

We’ll be improving information to patients.

Patients will be able to report to national authorities.
There will be a notice on the patient-information leaflet encouraging people to report any adverse reaction.

There will also be a black symbol on new products.

At the moment, healthcare professionals know, when they, as healthcare professionals, give you, as a patient, a new product, that this product has adverse reactions.
You as a patient do not know the adverse reaction.
The healthcare professionals knows [the kind of adverse reactions the patient] should be looking for, but you as a patient do not know.

BETTER PUBLIC INFORMATION

One-stop web portal on medicines bringing together all the different information about medicine safety.

The patient-information leaflet will contain the kind of information you’ve got, at the moment, to spend hours and hours putting together.

For the drug companies, the gains will be in terms of streamlining procedures, cutting duplication of reporting, and the freeing-up of resources for more important research work. [Ivo: The costs for drug companies do not matter for the eurocrats]

These are changes, which, I believe, Mr. President, will vastly improve the whole system of pharmaco- vigilance in Europe.

And finally, I want to thank [some eurocrat colleagues who have enabled to produce this shXX -   blahblahblah]

Transcribed at Siquijor, on 24 September 2010

Ivo Cerckel
honestmoney@maktoob.com

Ivo’s note:

(1)
other press reports, which however do not include the speech, are

EU verschärft die Arzneimittelüberwachung
 22.09.10 | 14:01 Uhr
http://www.ad-hoc-news.de/eu-verschaerft-die-arzneimittelueberwachung–/de/News/21618314
 
Effets secondaires des médicaments: l’UE crée un système d’alerte renforcé
AFP / 22 septembre 2010 12h51
http://www.romandie.com/infos/news2/100922105122.d68ug94k.asp

EU beefs up medicine surveillance rules`
Published: 23 September 2010  The EU is to strengthen its drug monitoring systems and force high-risk medicines to carry a black symbol on their packaging as part of tough new rules passed by MEPs yesterday (22 September)
http://www.euractiv.com/en/health/eu-beefs-medicine-surveillance-rules-news-498049

McAvan own website contains some reference to some only of the drafts of the proposal in this post:
Linda Helps Patients Win New Rights to Information from EU Pharma Deal
22nd September 2010
http://www.lindamcavanmep.org.uk/news/2010/09/22