The Director General of the World Intellectual Property Organization (WIPO) presents his compliments to the Minister for Foreign Affairs and has the honor to notify him of the receipt from the Government of the United Kingdom of Great Britain and Northern Ireland, on November 9, 2004, of a written communication dated November 5, 2004, relating to the acquisition of the status of International Depositary Authority by the National Institute for Biological Standards and Control (NIBSC), which states that this Depositary Institution is located on the territory of the United Kingdom of Great Britain and Northern Ireland and includes a Declaration of Assurances to the effect that the Institution complies and will continue to comply with the requirements concerning the acquisition of the status of International Depositary Authority specified in Article 6(2) of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, done at Budapest on April 28, 1977, and amended on September 26, 1980.
Pursuant to Article 7(2)(b), the National Institute for Biological Standards and Control (NIBSC) shall acquire the status of International Depositary Authority under the Budapest Treaty on December 16, 2004, that is, on the day of publication of this notification.
December 16, 2004
Text of the Communication from the Government of the United Kingdom of Great Britain and Northern Ireland Relating to the Nomination of the National Institute for Biological Standards and Control (NIBSC) as an International Depositary Authority
[Original: English]
COMMUNICATION
The Permanent Mission of the United Kingdom of Great Britain and Northern Ireland to the United Nations in Geneva presents its compliments to the World Intellectual Property Organization (WIPO) and has the honour to refer to the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, opened for signature at Budapest from April 28 to December 31, 1977. In accordance with the provisions of Article 7 of the said Treaty, the Government of the United Kingdom of Great Britain and Northern Ireland nominates the National Institute for Biological Standards and Control (NIBSC) as an International Depositary Authority.
ANNEX
Declaration of Assurances
The Government of the United Kingdom furnishes its assurance that the National Institute for Biological Standards and Control (NIBSC) complies and will continue to comply with the requirements specified in Article 6(2) of the Treaty for an International Depositary Authority.
Information on the Depositary Authority
1. Name and address:
National Institute for Biological Standards and Control (NIBSC)
Blanche Lane
South Mimms
Potters Bar
Herts., EN6 3QG
Telephone: (+44-(0)) 1707 641 000
Facsimile: (+44-(0)) 1707 646 730
E-mail: enquiries@nibsc.ac.uk
2. Detailed information as to the capacity of the NIBSC to comply with the requirements of the Budapest Treaty:
The National Institute for Biological Standards and Control (NIBSC) is the operational unit of the National Biological Standards Board (NBSB). NBSB is a public body formed by statute - the National Biological Standards Act, 1976. Its functions are set out in the National Biological Standards Board (Functions) Order (Statutory Instrument 1976 No. 917). The Board took over scientific activities formerly carried out by other publicly funded bodies, including the National Institute for Medical Research, and the work of Sir Henry Dale and Sir Percival Hartley in biological standardisation since the 1920's. NBSB's core activities are funded by grant in aid of some £11 million annually from the Department of Health. The Board supplements this with income from research grants.
In addition to its core government and research grant funding, NIBSC receives fees for its services in the normal course of business from commercial organisations. It also carries out services for such organisations under service contracts, which are undertaken only after scrutiny against the Board's personal and institutional conflict of interest policy. In addition to the normal duties of confidentiality in English law, client information is protected by Section 5 of the Biological Standards Act, which provide for fines and imprisonment of Board members or employees who improperly disclose "a manufacturing process or trade secret". The Board routinely enters into confidentiality agreements with its counterparts in commercial and research activities.
The quality and validity of the control work undertaken at NIBSC is accredited by the United Kingdom Accreditation Service (UKAS) to comply with the International Standard BS EN ISO/IEC 17025.
The Institute is also a World Health Organisation (WHO) International Laboratory for Biological Standards and as such prepares and evaluates ampouled biological reference substances which serve the pharmaceutical, regulatory and research communities as International Standards.
NIBSC has about 300 staff of whom two-thirds are scientifically or technically qualified. Staff are encouraged to publish in peer reviewed journals. Many staff are members of UK, European and international committees and working parties which define future requirements for ensuring the quality and safety of biological medicines.
In September 2002, NIBSC was selected to host the new UK Stem Cell Bank funded by the Medical Research Council (MRC) and the Biotechnology and Biological Sciences Research Council (BBSRC). The UK Stem Cell Bank will provide a repository for and accept the deposit of cell lines of all types, and will be developed to supply well characterised cell lines both for basic research and for the development of clinical applications under appropriate and accredited quality systems. The Bank will be administrated by a Management Committee with representatives from research, healthcare and regulatory bodies and also includes a lay member. This group will monitor and develop the bank with a remit to enhance the range and quality of cell lines available for research and therapy. The operating language of the bank will be English.
Specialist clean room laboratories have been set up for both research grade stem cell lines and cell cultures intended for use in humans. The laboratory procedures including staff training have been established consistent with the ISO17025 quality standards relating to laboratory testing and monitoring for which the Institute's vaccine batch release testing work is performed and accredited. These facilities and procedures have been inspected by the Medical and Healthcare Products Regulatory Authority and accredited under the UK Code of Practice for Tissue Banks.
Staff have been recruited specifically for their experience in cell culture and include senior staff with a track record in stem cell research and tissue banking. Training is carried out in collaboration with outside laboratories with expertise in stem cell culture and characterisation and supplementary training for particularly difficult to grow cell lines is developed with depositors.
In accordance with Rule 6.3(a) of the Regulations of the Budapest Treaty, NIBSC will require the following before a deposit will be accepted:
- that the deposit must be in appropriate form and quantity to permit NIBSC to fulfill its obligations under the Regulations to the Budapest Treaty;
- that a form established by NIBSC and duly completed by the depositor for the purposes of NIBSC's administrative procedures be furnished;
- that the written statement indicated in Rule 6.1(a) or Rule 6.2(a) be properly completed in English;
- that the fee for storage of the deposit be paid;
- that the depositor obtains all necessary permits for the transportation and storage of the deposit.
In accordance with the Regulations of the Budapest Treaty, NIBSC will:
- test each deposit for viability and store it;
- issue receipts on Form BP/4, viability statements on Form BP/9 and other official notifications as required;
- comply with the prescribed secrecy requirements;
- furnish samples under the conditions of and in conformity with the prescribed procedures in an expeditious and proper manner.
An accession number system based on providing a new accession number on each occasion a new culture is received has been in place for a number of years. The current sales order processing system at NIBSC operates for stocks of over 2,000 reference materials and has been fully operational for more than two years. A variety of shipment formats are handled for world-wide distribution including "dry-ice" packages. The protocols for sales order processing are audited under ISO9000 and include a series of more than five documented checkpoints to assure appropriate responses to customers and timely delivery. Critical checkpoints include review of specific requirements and documentation (e.g. materials transfer agreements, regulatory and legal requirements, confirmation of import/export restrictions). The service has a target for at least 90% of requests to be despatched within six working days and a success rate of 96% has been achieved consistently. In addition, a supplementary process for handling request for cell lines has also been instigated which applies reference numbers to each request for cell despatch and maintains a file of communications and other relevant information.
3. Kinds of microorganisms accepted as patent deposits:
Cell lines of all types, and in particular stem cells.
4. Schedule of fees:
The following IDA fees will apply to NIBSC clients:
| Cell lines | GBP | ||
| (a) | Deposit and storage, including certification and viability statement | 950 | |
| (b) | Issuance of a (new or updated) viability statement | 80 | |
| (c) | Furnishing of a sample (excluding carriage costs) | 100 | |
| (d) | Issuance of (new or amended) certification | 50 | |
| (e) | Administration fee for amendments | 50 | |
Fees plus VAT, where applicable, are payable to NIBSC.
5. Official language: English