EU Direktiva o tradicionalnih medicinskih zeliščnih pripravkih

V začetku aprila 2011 naj bi v Evropski Skupnosti začela polno veljati uredba o tradicionalnih medicinskih zeliščnih pripravkih, ki naj bi določala, da morajo le-ti biti registrirani na enak način kot farmacevtska zdravila. Stroški tega postopka so zelo visoki (od 80.000 do 120.000 funtov samo za eno zelišče), zato je precej verjetno, da mnogi herbalni pripravki ne bodo registrirani in jih tako ne bo moč dobiti. Na tako ne fer zakonodajo lahko vplivamo preko svojih predstavnikov v evropskem parlamentu. Dajmo jim vedet, da imamo vsi pravico lahkega dostopa do tradicionalnih pripravkov. Več informacij o sami uredbi dobite tukaj:
http://www.anh-europe.org/campaigns/protect-traditional-medicinal-cultures

Tukaj je vzorčno pismo, ki ga lahko pošljete:

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Spoštovani,

Sem podpornik uveljavljenih tradicionalnih medicinskih sistemov, ki temeljijo na naravnih zeliščih, vključno s tistimi, ki izvirajo iz ne-evropskih držav.

Omenjena evropska direktiva iz l. 2004 določa, da morajo biti vsi herbalni pripravki podvrženi enakim postopkom registracije kot farmacevtska zdravila, pri čemer ni pomembno, ali so pripravki uspešno v uporabi ze stotine let. Stroški registracije so za vešino malih proizvajalcev preveliki; ocenjuje se, da znašajo od 80.000 do 120.000 funtov za posamezno zelišče. Za velike multinacionalne farmacevtske družbe taksne vsote seveda niso nikakršen problem.

Do danes noben kitajski ali indijski (ajurvedski) pripravek še ni dobil licence v okviru sheme, ki jo določa evropska uredba. Zelo me skrbi, da bodo ti pripravki, do katerih imamo pravico vsi državljani, po 31. marcu 2011 postali nelegalni ter bodo tako postali nedostopni za veliko ljudi.

Ta uredba nujno potrebuje amandmaje, ki jo bodo prilagodili ne-evropskim kulturam, ki uporabljajo zeliščne pripravke.

Obračam se na Vas, da uporabite svoj vpliv ter pritisnete na vlado ter Generalni direktorat za zdravje in zadeve potrošnikov (Directorate General for Health and Consumer Affairs – DG SANCO), da bodo ustrezni amandmaji sprejeti. Kajti konec koncev smo potrošniki prav vsi in nikoli se ne ve, kdaj bomo mi (oziroma kdo iz naše družine) potrebovali herbalni pripravek.

Več informacij boste nasli na teh spletnih straneh Alliance for Natural Health:
http://www.anh-europe.org/campaigns/protect-traditional-medicinal-cultures

Lepo Vas pozdravljam!

podpis, kraj

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Naslovi evroposlancev pa so:

tanja.fajon@europarl.europa.eu, romana.jordancizelj@europarl.europa.eu, jelko.kacin@europarl.europa.eu, alojz.peterle@europarl.europa.eu, zoran.thaler@europarl.europa.eu, ivo.vajgl@europarl.europa.eu, milan.zver@europarl.europa.eu
Pošiljanje pisma vzame 2 minuti vašega časa. Prosim posredujte to pošto naprej, če lahko!

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In še prirejeno sporočilo v angleščini za prijatelje v tujini:

Hi,

In the beginning of April 2011, the European Directive on Traditional Herbal Medicinal Products will be fully implemented. It states that herbal medicines must undergo the same procedure of registration than pharmaceutical medicines. The costs for that are extremely high (estimated from 80.000 to 120.000 pounds per only one herb), so it is clear that most of small manufacturers, many of which come from China or India, will be able to afford this. As a consequence, many of these medicines will possibly not be registered and thus will become illegal, meanning they will be unavailable to the people. Needless to say, big multinational pharmaceutical companies can easily meet the costs of registration.

This legislation is clearly in favour of multinational drug companies at the expense of ordinary people and their health. Let us have our say with our representatives in European parliament and let them know we do not support it. Below you will find a sample letter you can send to representatives from your country. before you do that, it is useful to check some more facts about the Directive on the following website:

http://www.anh-europe.org/campaigns/protect-traditional-medicinal-cultures

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Dear…,

I am a great supporter of long-standing traditional medicinal systems, including those that have developed over thousands of years in non-European countries.
This directive requires that all herbal preparations must be put through the same kind of procedure as pharmaceuticals. It makes no difference whether a herb has been in common use for thousands of years. The costs for this are far higher than most manufacturers, other than Big Pharma, can bear, with estimates ranging from £80,000 to £120,000 per herb, and with each herb of a compound having to be treated separately.
So far not a single Chinese or Indian (Ayurvedic) herbal product has been licensed under the scheme provided by the directive. I am very concerned that herbs from these traditions that I have been using as food supplements for the last __ years will be banned when the directive’s transition phase expires on 31 march 2011.
Amendments to this directive are urgently needed, to make them more applicable to non-European herbal cultures.
I urge you to put pressure on our government and Directorate General for Health and Consumer Affairs (DG SANCO) to initiate such amendments.
You can find more information on the following website:

http://www.anh-europe.org/campaigns/protect-traditional-medicinal-cultures
Very best wishes
signature, place

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You can find your representative in the European parliament on this website:

Europarl.europa.eu

Sending this message takes only a few minutes of your time. Please do your bit and send the message to everyone you know. Let’s take action!

                  

Več o tej temi:

Dokument: Direktiva 2004/24/ES

Direktiva 2004 o spremembi Direktive 2001/83/ES o Kodeksu Skupnosti o zdravilih za uporabo v humani medicini gledetradicionalnih zdravil rastlinskega izvora

 Toksikološki in farmakološki preizkusi

                   

Avtor objave: Aleš Praprotnik