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Sanquin changes MSM policy

The Dutch Minister of Health announced yesterday that following Sanquin's advice the deferral period for MSM will change from lifetime deferral to one year, starting December 1st 2015. 

One year year deferral now... 

“I am a staunch supporter of emancipation and equality of people, and at the same time responsible for the safe blood supply in the Netherlands,” Health minister Edith Schippers, pictured right, said in a statement. Jeroen de Wit noted that he was happy with this outcome: "I'm happy to change this policy because it might solve a long discussion between human rights and patient safety. I'm convinced that patient safety will not be influenced by this change, given the research done".
On the process of the change, he reported that it "has been very confidential with the MoH and other stakeholders, but in good cooperation". Due to the confidential process, he regretted not being able to not speak out earlier to EBA Members". He further pointed to the letter with which the Minister informed the parliament of this change in policy: "This letter is now in Dutch, but as it contains well-thought reasons why we decided on this change. This letter is being translated by the MoH and will be circulated to EBA members." The letter in Dutch can be read here [pdf, 220kb], together with the attachment [pdf, 82kB].

...perhaps even shorter in the future
Together with Sanquin the Health Minister will assess whether a shorter period will be possible in the future, based on international developments and studies. Gay, Lesbian, Bisexual and Transgender (LGBT) advocates consider a year ban still too high: “The policy is only of practical importance for bisexual men in long-term monogamous relationships with a woman”, said the president of the LGBT association in the Netherlands. In their statement, the MoH noted that this decision had been taken with all stakeholders, including the Dutch Hemofiliac assocation.
 
No change for Plasma Derived Medicinal Products (PDMP)
This change will not affect the apheresis and recovered plasma that is collected for PDMPs, for which a life time deferral for MSM will remain in place. 

Merge of EU Scientific Committees

Merge SCHER and SCENIHR
a new Commission Decision C(2015)5383 on establishing Scientific Committees in the field of public health, consumer safety and the environment was adopted on 7 August 2015.
The major changes compared to the previous organisation of the Committees consist in the merge of SCHER and SCENIHR Committees to constitute the SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), the abolition of the pool of advisers and the creation of a reserve list of members, the prolongation of the duration of the term (from 3 to 5 years) and the transposition of Commission Decision on expert groups rules concerning special allowances.

Call for members
As the terms of office of the current Committees expire beginning of April 2016 a call for membership was published on 14th August 2015 on DG SANTE and Scientific Committees websites. The deadline for applications is 2nd of November 2015. 

Joëlle's Blog: Seminar on Collaborative Procurement, Save the Date!

Earlier, I announced that EBA will host a seminar on Collaborative Procurement. Now, we have more details to tell you - and Monday you will receive the agenda and the registration form!
The seminar will be kindly hosted by the German Red Cross - Baden-Wuerttenberg - Hessen and will be held in their head office in Frankfurt. 

Mark 10 and 11 December in your calendars!
The coming seminar will be held covering two days and consist of eight sessions structured around the following topics:

Day 01:
-    The potential of Collaborative procurement
-    Collaborative procurement applied to blood services
-    EBA Collaborative Quality Management
-    EBA Collaborative Procurement Foundations
-    EBA CP projects: Tubes and laboratory consumables

Day 02:
-    EBA CP Projects: Eurobloodpack 1
-    EBA CP projects: Eurobloodpack 2
-    How will bloodbags look like in 2020?

The days will be most useful for the colleagues with the following profiles:
-    For the 2 Days: EBA Members procurement, suppliers’ audits & suppliers relationship management experts, contracting & purchasing contracts experts. Representatives of EBA Members interested in Collaborative Procurement.
-    Additionnal participants for the second day: EBA Members experts in blood bags, blood collection and blood processing. Experts in R&D and Innovation.
Please kindly take the time to start identifying participants within your organisations.

Full agenda and the link to an online registration form will be sent to you next Monday.

Kind regards, Joëlle

Organisational change ICH and development of ICMRA

At the occasion of their 25th anniversary, the International Conference on Harmonisation (ICH) announced a change in organisation. Even though the name will change to International Council for Harmonisation, their acronym will remain the same.

Change in membership
The change will involve accepting more members besides the current group of Health Canada (Canada), European Commission (EU), Ministry of Health Labor and Welfare/Pharmaceuticals and Medical Devices Agency (Japan), Swissmedic (Switzerland), Food and Drug Administration (USA). It will now include the following 3 industry members: European Federation of Pharmaceutical Industries and Associations (EU), Pharmaceutical Research and Manufacturers of America (USA) and Japan Pharmaceutical Manufacturers Association (Japan).

Goals of the ICH
In the 74th Pharmaceutical Committee, the goals of the ICH were presented as being
  1. Focus global pharmaceutical regulatory harmonisation work in one venue 
  2. Create a venue that allows all key pharmaceutical regulatory authorities and industry stakeholders the
  3. opportunity to be more actively involved in pharmaceutical harmonisation work
  4. Maintain efficient and well-managed operations and harmonisation work processes 
Consequences and background
Pharmaceutical Technology remarks in an article on the consequences of this reform that: "it could trigger radical changes in the way pharmaceutical regulations are harmonized throughout the world", noting that several bodies could now start competing "to be the main driving force behind endeavours to make the regulation of medicines more responsive to conditions in the global pharmaceuticals marketplace". In the past, the ICH was very successful with creating more consistency in GMP guidelines, but with increasing globalisation, their limited membership was failing this development.

ICMRA overlap?
In 2014, the International Conference of Drug Regulatory Authorities was set up, with overlapping membership, posing the question of whether this conference does not duplicate the work of the ICH. On the website of Health Canada, they state that: "The ICMRA recognizes the range and depth of regulatory contributions and leadership that exist, including for example, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), the International Pharmaceutical Regulators Forum (IPRF), the International Medical Device Regulators Forum (IMDRF) and of course, the leadership of multilateral organizations such as the World Health Organization and its Regional Offices." but they do see a niche for their existence: "The ICMRA works at the strategic level to leverage these initiatives and others in partnership, expanding our global regulatory reach in meaningful and sustainable ways and, over time, identifying additional opportunities for regulatory collaboration. To date, there has not been coordinated, consistent, and strategic global regulatory leadership and the ICMRA endeavors to fill that gap."

Change of Main telephone Number for SNBTS Head Office 

The reception number for SNBTS Headquarters at 21 Ellen’s Glen Road, Edinburgh will change. With effect from 1st January 2016 the main reception number will change from 0131 – 536 5700 to 0131 – 314 5510. SNBTS would be grateful if you could update your records accordingly.

EBAse training sessions and progress

All Board Members received the question who to add on EBAse for their organisation. Some have already returned that, and in the week 46 all will receive an email from the EBA Office with login details.

For November, two training sessions have been scheduled for EBAse:
17 November 17.00 CET
20 November 13.00 CET

Please do contact Willemijn Kramer if you want to join one of them!

EBA Calendar

November
  • EBA | Tissues & Cells | workshop for banking of femoral heads | 5-6 November, Liverpool, UK | contact WG chairs Primož Rožman and Jorge van Kats
  • EBA | Second PaBloE meeting for subgroup chairs | 18 November 2015 | Frankfurt, Germany
  • EBA | Training EBAse | 17 November 2015 | general training | 17.00pm
  • EBA | Training EBAse | 20 November 2015 | WG chairs + members | 13.00pm

December

January 2016
  • DoHeCa | Meeting of the Project Group | 14-15 January | Berlin, Germany | contact chair Peter van den Burg

February 2016
  • EBA Benchmarking Workshop | Integrated Transfusion Services | 9-10 February | Charité Hospital, Berlin - Germany | information: Steve Morgan 

April 2016
  • EBA | 37th Board Meeting | 7 - 8 April 2016 | Zagreb, Croatia | Contact Willemijn Kramer

July 2016
  • Second European Conference on Donor Health & Management | Cambridge, UK |  Contact: ecdhm@medschl.cam.ac.uk.​

October 2016


 
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