Basically the prime need of the laboratory lies with GoS, but for swift transfer of technology, optimum performance and quality output of it will require association of University and to ensure it’s sustainability association of a well experienced private sector partner. The allocation of money and other resources will not be the actual concern of the government, but their rational use would be the prime apprehension. GoS needing technical assistance of a research institute and a business firm and in return these partners will provide skilful support in establishment of a hi-tech laboratory and manufacturing high quality product under world class Standard Operative Procedures (SOPs), and to ensure continuous capacity building of the system.
Hence the initial and major share in terms of investment and resources will be born by GoS, and the remaining as required will be shared by University and PS firm. Ideally the quantum of the share for University and the private sector firm can be left for them to decide but keeping it much flexible may cause a superfluous consideration on their part totally ineffective to build any firm bondage or serious association with the project. A reasonable share will keep them vigilant to participate actively and not to consider any half way dropout. A well described responsibilities and resource sharing plan prior to private partner selection will help filtrating serious firms well prepared to share agreed resources and responsibilities.
The agreeable share will be determined by project steering/ management committee at the appropriate time based on further discussions with University and proposed Private Sector Partners.
Anticipated Stakeholders Responsibilities.
Following is the tentative responsibility sharing plan among the partners to be confirmed by the project execution/management committee. However any expansion or modification of the responsibility sharing plan if desired after formal partnership can be done by seeking consensus of all the partners.
- Health Department.
Provincial Health Department is sharing most of the project establishment and execution cost and also the project recurring cost till the production seeks market appreciation. It will provide money for purchase of land, construction of lab systems and other affiliated infrastructure, lab equipment, renovation and alteration of building space provided by the university or GoS and transportation required for animal farming or lab operations. The GoS will be responsible to provide all legal and administrative support for lab operations and for use of product for human consumption and will pursue any process required for issuance of any government certification, ordinance, or assembly resolution. As the University and private Sector firm are going to investment fair amount they will certainly to have an assurance by GoS for at least 10 years purchase of lab products.
The responsibilities to be shared by HD will be:
- Issuance of Directives for formal setting up of ASV Project.
- Select and appoint Project Director (PD)
- Issue administrative and other directives till PD start holding the charge of project execution, implantation and operation.
- Seeking necessary permission for use of ASV for human consumption from relevant departments,/competent authorities within provincial and federal governments (including formal registration with Ministry of Health) for or manufacturing, distribution and sale.
- Provide market security for ASV and ARV and also security for other similar products.
- Arrangement of funds according to an agreed schedule.
- Provide advisory inputs and assist operational functioning of Board of Directors.
- Provide assistance from co-related other government departments and institutions.
- Provide legal coverage and security to project assets, processes, manpower, and functions within the purview of country law.
The responsibilities of HD may be formally agreed after thorough deliberations of all stake holders.
University is required to provide adequate and appropriate space for quality control of the project. It will barrow the cost of chemicals, reagents, consumables and some of the lab equipments and also the cost of electrical, gas, telephone and water supplies used for project operations. It will be required to provide technical assistance for capacity or skill enhancement. The university will design and implement a project centered program on mass awareness, education, community mobilization, first aid snake bite case management, and a comprehensive communication, education and information dissemination program for various target groups. It is mandatory for university to design and implement short and long term courses on the subject. The continuous research and up gradation of techniques will be another area of university interventions. It will be responsible for providing equally or better qualified replacement of any retiring or leaving skilled manpower.
The University will be responsible for:
- Spearhead the project under an umbrella for effective partnership.
- Assist in identification of appropriate consultant/s, land for lab and farm house, selection of appropriate technology, and drafting specification of various equipments and consumables.
- Provide initial supervision, administrative and logistic support whenever possible until the project becomes converted to a manufacturing unit.
- Facilitate approvals from Government of Sindh and other government departments
- Assist in financial and functional management
- Assist in selection of private partner, initial tenders, contracts and procurements.
- Provide technical assistance in infrastructure, software and information concerns of the project.
- Assist in developing national and international linkages with allied organizations.
- Mobilize local participation for successful launch of ASVS Project (Snake farming, venom extraction and drying etc)
The responsibilities of University can further be discussed and formally agreed after thorough deliberations of all stake holders.
- Private Sector Firm
The private sector firm will be required for transfer of technology and marketing to explore best possible opportunities for selling the product to potential buyers within and outside country other than Sindh Government and definitely for reasonable investment. It can share all the management responsibilities through it’s representative in BoDs. It will take care of technical matters of the project including but not limited to: extraction, drying and purification of snake venom, its inoculation to different animals, extraction of blood from the hyper-immunized animals, separation and preservation of immuno-globulins, quality control of the product for human consumption, etc.
The anticipated responsibilities of private partner are summarized below:
- Provide ongoing quality ASV-specific technical expertise of an international standard, and facilitate a process of transfer of technology from regional or international organizations of high repute. .
- Assist in selection of appropriate machine and equipment
- Assist in preparing architecture, design and layout of manufacturing facility
- Assist in Identifying suitable equipment supply source for cost effectiveness and quality.
- Formulate protocols, SOPs, processes and systems for plant operations
- Assist in supervising and monitoring the assembly and construction of machinery
- Suggest on selecting suitable equipment for laboratories (QC and QA)
- Suggest on design and establishment of animal house
- Explore export options beyond national requirements.
- Help in setting biological and environmental safety.
- Facilitate Validation of process, machinery/equipment and products through local and international agencies
- Assist in certifications from international agencies for quality assurance
- Recommend on regular update/up gradation of processes, systems, and machines
- Provide technical dossier for product validation/registration
- Maintain liaison with other international manufacturers and research entities for product improvement and Research and Development inputs.
- Provide continuous and progressive technical consultancy for operations
The responsibilities of private sector firm can further be discussed and finalized after thorough deliberations of all stake holders.
Selection of Private Sector Firm.
Due to scarcity of skilful manufacturing firms in local market and surely due to less attractive market benefits sleek response from international firms for partnership can be expected. In such a situation sketching tough or less flexible criterion for selection of a private sector partner would be unrealistic. Even than it is essential to set certain selection parameters to avoid any sub standard partner or to have any adventurist or beginner partner. Besides good financial health, commendable market reputation, tangible access to local and international markets, the anticipated partner should preferably have adequate experience of globally accepted quality sera or vaccine manufacturing. The international partner is preferred on a local partner if they provide ample evidence of their ability for swift transfer of some advance technology at their own cost and efforts with firm promise for unconditional training and capacity building of local counterparts. They have to show concrete evidence that they are already having ample technical and marketing network in a developing country like Pakistan and are well versed with local working environment on similar themes. It will require thorough analyses before taking an international partner on board because the experience so far of power generation joint projects and other similar ventures of public private sector partnership could not establish so far any national interest preserving accord. Any such misbalancing interaction in this case will be more damaging if a legal compulsion leads allows very high prices of the project products beyond the capacity of general masses or even of governments. The other likely complication of a less attentive bond can be a business oriented supply preference to international market before satisfying the local needs.
While selecting private sector partner it is important to level their expectations from very beginning if they are considering full command of lab operations, marketing and price fixation.
A technical committee constituted by Health Department having representatives of Health Department Sindh, University and an external expert (hired as consultant) or any other consultant/ consultants selected by the project steering/ management committee will invite Expression of Interest in the National and International newspapers and will keep ready an initial draft of TOR having description about modes operandi of partnership, anticipated financial and functional responsibilities of private firm, security to it’s investments, legal authority in the project and any other relevant information the applicant firms intend to have. After receiving the EoIs the technical committee will present it’s recommendations to project steering/ management committee for final selection of private firm. The technical committee will be authorized to ask any documentary or other proof in support of their presentations in EoI.
After selection of Private firm the formal procedure of partnership among all the three stakeholders will be completed as described above.
Proposed Attributes of Private Sector Partner subject to approval by project execution/ management committee.
- Have at least 5-10 years of vaccines/ sera manufacturing experience.
- Manufacturing facility of the Private Partner should be operational and functional at the time of extending EoI.
- Possess in-house hi-tech laboratory with multiple vaccine/ sera production and testing capability, well qualified and skilled manpower, appropriate machines and equipment.
- Good command of tests required for ASV production and quality control.
- The manufacturing facility of Private Partner should be GMP complied.
- The Private Partner must have shown ISO certified quality standards both in manufacturing and quality control validated by a WHO or equivalent accredited referral laboratory.
- Should have properly qualified trained and experienced human resource to assist in setting up, operate and upgrade the facility for ASV manufacturing.
- Should have capability to source, acquire, arrange and transfer the requisite technology for ASV manufacturing and to set up a supporting system of upgrading/ modernizing the same from time to time.
- Should have capability to design layout plans and supervise the infrastructure and management of ASV plant.
- Should have the experience of setting up and operating a properly equipped and designed animal house.
- Should preferably possess the capability to promote and market the product within and outside Pakistan.
- Should have a distribution network and well skilled sales team for province/ country-wide availability of ASVS.
- Should have experience of handling corporate business in vaccines/sera.
- Possess capacity to provide initial orientation training on lab establishment.