+ European Medicine Quality Director, dr. Keitel to EuroFora: Gene Therapies to arrive in 1 Year ?

 

*Strasbourg/CoE/Angelo Marcopolo/- "Gene Therapies" are among several New Scientific/Technological developments which may soon become, for the 1st time in History, so concrete realities in everyday life, that the prestigious PanEuropean Directorate for the Quality of Medicine (EDQM), a CoE's body of Experts setting Standards on Medical products as Drugs, etc, is due to publish Next Year (2015) its first International Recommendations on such New practices, finalizing a work already started since 2012, revealed to "EuroFora" the experienced EDQM's Director, Dr Suzanne Keitel, from Sweden.

As a matter of general Principle, EQM's Directorate issues Recommendations and/or Certificates on the Quality of concrete Medicinal products only after they have been given a "Green Light" by the competent Authorities at National levels. But G-T is part of those "New Challenges" that EU Commission's Director on Health Systems and Products, Dr. Andrej Rys, had briefly Highlighted, earlier, speaking, f.ex., also about the Transition "from Chemical to Biological Drugs", such as "Cell Therapy", etc.

In such matters, even usual Technical terms, such as f.ex. that of "Impurities", etc., don't have no more the same simple Meaning as in the Past, since now what is at stake is a Biological "Process", told us, meanwhile, an experienced  American Expert, just 1 Day before a Group of EDQM's Experts discusses Tomorrow the issues raised by Drug impurities which are "DNA-reactive".

+ "Advanced Therapies", "Personalized Medicine", "Drugs that exist only for a Short laps of Time, (f.ex. just "Half a Day"  !), etc, are among the various, manifold New Medical Products that Strasbourg's PanEuropean Watchdog on the Quality of Medicine, EQM Directorate, would soon have to deal with, as well as the World Health Organization (WHO) at a Global level, responsible for an International "Pharmacopoeial Harmonisation", since, nowadays, "Drugs are invented and/or produced almost everywhere in the World", faster than before.

These aren't but just a few examples of the much more, various and serious Challenges that, 50 Years after the creation of the PanEuropean Pharmacopeia ("Drug-Making" Standards), Headquartered in Strasbourg, have just started to be Discussed during an exceptional, 3 Days-long International Conference, bringing Together Public Authorities, Scientists and Industry throughout Europe and many other Countries in the World (i.e. USA, Canada Japan, China, Australia, Brazil, India, etc), which is organized in the CoE at the Anniversary of EQM Directorate's "Birthday", already strong of 37 full Member Countries, but aiming to both enlarge its Regional area (f.ex. towards a Full Membership of Russia and/or other Countries), and boost its position as Quality reference in a Globalized World, where the Demand of Generic Medicines is Growing, while Medicines can be produced by Different Manufacturing processes, as observed the Chair of the European Pharmacopoeia's Commission, Dr. Jean-Louis Robert from Luxembourg, (who pointed alsp at the practical "Speed" gained in Europe by Networking Together many Countries, which can, thus, react much Faster in cases of "Urgency", as f.ex. on the Crisis of "Transmissible Encephalopathy" in the recent Past, than if each Country had been obliged to react in a separate manner, one after the other).

- Setting "Quality Standards for Safe Medicines and their Safe Use", has an "Undeniable Positive Impact .. on Public Health", "protecting European Patients", as well as "improving the Health and Dignity of all Citizens of Europe", said earlier at the Official Opening of EDQM's International Conference,  CoE Parliamentary Assembly's President, Anne Brasseur, who promissed to Help Boost Ratifications by even more Countries, and to promote, f.ex. the relevant CoE's Treaty which serves to Fight against "Counterfeiting of Medicines", etc, often as a result of "Organized Crime", as she denounced.

- But, "Guaranteing that the Quality of Medicines produced in Europe would be the Same for All Citizens", and j "protecting Patients' Health by ensuring the Quality, Efficiency and Safety of Medicines, is a Constant Challenge", and "it requires keeping Up-to-Date on Scientific and Therapeutic Developments", added earlier CoE's Deputy Secretary General, the Gabriella Battaini-Dragoni, who praised also EQM Directorate's "Collaboration with the EU", resulting f.ex. from the "Biological Standardisation Programme", the "Network of Official Medicines Control Laboratories", (which, inter alia, includes also "the Testing of Pharmaceutical preparations produced in Community  and Hospital Pharmacies", as she noted in her Welcome Adress, earlier Today, where she was the Keynote Speaker).

 

However,  well-experienced Battaini-Dragoni, as No 2 of the CoE, which organises just in 1 and same week .. 3 International Conferences on Quality Standards of Medicine (EDQM - Strasbourg), Organisation of Justice (CEPEJ - Paris),  and Constitutional Law ("Venice Commission" - Rome), would probably find Strange the fact that, just a few meters away : at the recently inaugurated, charming "Lieu d' Europe" villa ("European area/spot"), a quasi-"Official" CoE Video containing a brief but overall Presentantion of the PanEuropean Organisation on Human Rights, Democracy and Rue of Law, and dedicated in particular on the List of its Legal "Treaties" and Conventions in various domains, astonishingly, mentions almost all other Texts, except only one :  ...That of the 1997 "Oviedo" CoE Convention on "Bio-Medicine and Human Rights", alias BioEthics !....

 

I.e., curiously, ommitting what seems due to become one of the most urgently needed pieces of legislation Today : CoE's 4.4.1997, No 164 "Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine" : An indispensable Complement...

 

 

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(NDLR : "DraftNews", as already sent to "EuroFora"s Subscibers/Donors, earlier. A more accurate, full Final Version, might be published asap).

 

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