The European Medicines Agency EMEA has a highly delicate balance to take care of when it comes to transparency: It has to weigh the interests of patients in knowing about the effects and side-effects of medicines against the interest of the pharmaceutical industry, who considers many of exactly the same information as business secrets.
So if you want to join the debate about information on your medicines in the future, act now! The EMEA who is taking care of a growing part of approvals and safety controls, has sent its new transparency strategy into public hearing, and the deadline of September 25th is approaching fast.
Medicine information professionals like the French medical journal Préscrire address serious criticism against the openness practice of the European agency, even using the verb “censoring”. Interestingly Préscrire has systematically tested the transparency of EMEA according to existing European access to documents regulations, and the outcome was rather devastating:
“The European agency censors certain important parts of documents including information of scientific interest, among them information about pharmacovigilance (safety evaluations of medicines). The interest of the patients is not taken well enough into account,” was the conclusion of Préscrire as late as July 2009.
In its hearing paper EMEA suggests that it intends to establish a register of documents – a register that has been obligatory according to the access to documents regulation since December of 2001.
Thus it is more than laudable, that the EMEA now addresses the problems, particularly as the agency observes an increasing number of requests from the public.
The balance between public interest and the interest to keep business secrets will often occur, however when it comes to medicines it appears to be particularly delicate.
On the one side patients desperately need to know, which side-effects the pills have, that they swallow, so that they can weigh them against the seriousness of the disease. European patients make out 31% of the worlds customers of the pharmaceutical industry, in other words they are a good market and should be respected.
On the other side the pharmaceutical industry in Europe with its € 187.153.000.000 production provides more than half a million jobs throughout the continent, the 2008 industry estimate was 635.000 jobs.
Seen from an openness point, the current draft does raise some concerns. The EU has – fortunately – an access to documents regime with a regulation and developing case-law. The EMEA being an agency is fully covered by this regulation and case-law and may not go its own ways. On the contrary it should comply fully with the regulation as it has been obliged to for years
On the transparency website Wobbing in Europe you can read a comment about the EMEA hearing document in relation to the European rules on access to documents.
Read the series of articles, where we got access to the previously secret reports about side effects and published stories about them in the Netherlands, Belgium, Denmark and on the Euobserver.
#1 by Tim Seretis on September 15, 2009 - 4:14 pm
Tim Seretis
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UNIVERSAL DECLARATION OF HUMAN RIGHTS
“Everyone has the right to a standard of living, adequate for, health and well-being of himself and of his family, including food, clothing, housing and medical care, and necessary social services. Everyone has the right to security in the event of unemployment, sickness, disability, widowhood, old age, or other lack of livelihood in circumstances beyond one’s control”.
For humanity to go forth, it is crucial that we realize we are all brothers and sisters. All over the world, including here in the United States of America, the so-called richest nation on earth, men, women, and children, do not have the essentials to stay alive. This crime should shame us all. We are not savages, yet we act like animals. Humanity, we call ourselves humans and we are above all other species, yet we allow children to die right before our eyes because they have no food, no water, no shelter, no future.
If humanity is to move forward, we must learn the concept of sharing with people everywhere. Can we as humanity stand alone and watch children die? NO!! It must end now! If humanity does not learn the concept of sharing and live peacefully, we will all perish. The lust for power, and money must end.
Sharing and Justice, Brotherhood and Freedom is nothing new, in fact that is what gave birth to this GREAT GOD BLESSED NATION of ours, the United States of America. All the riches of the world have been placed here on this soil, on this land, and we must take a moment to pause and ask WHY? The answer is simple, we must work together with other nations and realize that the lust for money and power in a monetary based economy, will bring the destruction of humanity. We need to open up our eyes, our hearts and souls and realize we need to become a resource based economy, and this will bring out the best in humanity.
For years I have been one of those that was wearing blinders. Just like a horse wearing blinders so it does not get distracted, I to was the same way. I was not able to see what was to the left or right of me. Could not see what was around me. I was also bombarded by rhetoric and brainwashed thinking that the only way to move forward is with more lust for power and greed, and to be in bed with all those that only saw one thing. MONEY! But that is over for me.
What happened to change me like this overnight? My friends, my piers, and even those who I argued with over political, national, world, and financial issues are asking what has happened? Most of them want nothing to do with me now. Most of them think that I have lost it and they are the ones that are truly in the right. So be it.
I can’t exactly pinpoint when I started to think this way, but I think deep down in my heart and soul, I always wanted to do something for those in need, and to speak out against the rape that is being committed by the world governments and the world financial entities. It is obvious with some of my many writings over the years, I did attack those entities, so yes, there must have been a dim light in my heart and soul, but now that light has lit up and my whole being and my whole focus will be in trying to make people aware the need to help and work with each other.
I have met some new people recently and yes, I do believe that GOD brings people together for a reason, even if it is for a minute, a day or a lifetime, there is plan at work, and with these new people around me, I am able to obtain and gather their knowledge and wisdom, and feelings about issues, and I do believe that these people were and are instrumental in opening my eyes and opening the light in my heart and I am now able to feel good about the direction I want to go, and I must ask to all, “the question is not where we are now, but what direction we are heading”. Is humanity going to achieve greatness, or is humanity going to regress back to the stone age?
Another wake up call for me was when a friend send me an E-mail with a youtube link that dealt with child poverty and hunger, and it broke my heart. I asked myself, what are we doing? Why are we allowing innocent lives starve to death?
Has the lust for money and greed blinded us all, and put a veil over our souls so we can’t feel pain for others in need?
Humanity must learn to share the resources GOD gave to us on this planet. Here in the United Stated alone we have the capacity to feed the world. Here in the United States we have the ability to give shelter and basic necessities to those in need throughout the world. The United States must take the lead and the initiative to bring in a new era of sharing, and slowly the rest of the nations will follow suit.
The United States must set forth a new agenda, and get out their lustful desires with money and power. The U.S Government must divorce itself from bankers, and those that are willing to sell their souls to the Devil for their personal gains, as the slaughter of innocent children is going on worldwide, even here in the United States.
Tomorrow begins today in making people aware, and with that in mind we must ourselves not where we are, but direction we are heading. Humanity must evolve to higher level, and not regress back to the dark ages.