JUNTA ADMINISTRATIVA DEL REGISTRO NACIONAL REGISTRO INMOBILIARIO

The industrial production of hepatitis B vaccine was achieved by the Biotechnology research centre of the Pasteur Institute of Iran in collaboration with the Centre for Genetic Engineering and Biotechnology (CIGB) at Havana. The hepatitis B vaccine technology transfer made the vaccination of a large proportion of Iran‘s children possible.

The strengthening of Iranian-Cuban cooperation began shortly after the Cuban aid to the Iranian earthquake of 1990. In 1993, Cuba and Iran signed their first biotechnology transfer agreement for recombinant hepatitis B vaccine at a cost of US$15 million per annum. In the same year, IPI (under MHME) established its biotechnology research centre. However international sanctions greatly hindered the import of laboratory equipment and machinery.

―Iran is under sanction by US and Europe. We encountered many hardships in access to machinery and equipment from Europe. In a few instances we managed to obtain the required equipment, for example we imported an equipment to purify water for injection purposes from ‗Chris‘ in Germany. They only agreed because the technology is used in many different industries, not solely in Biotech. The entire Europe avoided giving export licence for Iran and wasted our time and energy. At first the sanction was on fermenters but it expanded to other products. For example to purchase clean-room software and liofilizator we communicated with the ‗Telstar‘ of Spain for a long period, opened an LC for them and so on but they could not obtain the export licence. For fermenters we contacted different suppliers in Switzerland, Germany and Italy they couldn‘t obtain the export licence to Iran. Purification systems were very essential for us... Building bio-labs for research purposes is not difficult, but building a bio-lab for industrial purposes was a different story and we obtained the machinery with lots of difficulties through third parties. Even now we have problems with maintenance and spare parts. Learning quickly how to maintain and repair them is essential... (Interview with biopharma industry expert).

―Due to sanctions only Belgium [Smith Kline and Beecham] agreed to talks to us. […]. [We] visited the manufacturing site and signed a general agreement with the Belgians. However they either were not ready to transfer the complete technology to us or wanted to drag the technology transfer on for a long time. [...] So we decided that collaboration with Cuba would be more useful [...] and signed the contract for Hepatitis B vaccine technology transfer [...] In 1998, the new Minister of Health travelled to Cuba to sign new technology transfer contracts for streptokinase, erythropoietin, and IFN- α [...] It is good to transfer foreign knowledge as far as this is based on a thorough and long term strategy and vision [...] For Hepatitis B vaccine we sent around 50 staff for training in different areas of the production system such as protein chemistry, purification, fermentation, disruption, QA, QC,

and validation to Havana... Where we don‘t have the essential knowledge and technology, it is recommended to access foreign sources, but as soon as technology is obtained it has to be integrated and developed further. Especially young scientists and students should access this knowledge and develop it...‖ (Interview with biopharma industry expert)

In addition to the transfer of know-how, the collaboration agreement included training of personnel, on-going work of Cuban scientists and technicians in Iran, and shipment of necessary production equipment to Iran. So far, Cuba has provided advanced training in biotechnology to over 300 Iranian scientists (e.g. a senior scientist at IPI pursued advanced biotechnology studies in Cuba, completing postdoctoral training in protein characterization at Havana's CIGB from 1997 to 1998). MHME has provided grants for students on both sides.

In 1996 IPI formed a joint venture with Cuba's CIGB. Cuba provided the intellectual capital and technology and Iran provided the financing in the amount of US$60 million. This modern biotechnology production plant near Tehran has five units built on 14,000 square meters. The plant took 5 years to build (1996-2001).

In 1998, the Iranian Minister of Health visited Cuba and arranged the transfer of recombinant IFN- α, Streptokinase (used in the treatment of cardiac arrest), and Erythropoietin (used in the treatment of kidney failure). In 2000, the Iranian President Khatami (1997-2005) visited CIGB to support continuous scientific collaboration between Havana and Tehran. The above technology transfer projects were finally completed in 2005.

The technology transfer from Cuba‘s CIGB to IPI has played an important role in the growth of modern biopharmaceutical sector of Iran. Currently the production plant at IPI has a production capacity as follows:

Modern Biopharmaceutical Annual production capacity Hepatitis B vaccine 16 million doses

Erythropoietin 300,000 doses

Recombinant IFN-α 1.5 million doses

Streptokinase 120,000 doses

While these MHME mediated transfers of hepatitis B vaccine, IFN-α, streptokinase, and erythropoietin technologies from Cuba have boosted the technological capability of the sector. However government style administration and bureaucratic management practices are found unsuitable for commercialisation giving government additional incentive to support privatisation (e.g. case of IPI‘s production unit).

―…We need to increase and promote collaboration with the private sector. Private firms manage business much more effectively than IPI... If we had

transferred the technology for Hepatitis B vaccine to the private sector, it would have been commercialised much faster and more efficiently... Unfortunately, the huge potential of the hepatitis B plant in meeting domestic needs and export possibilities are being ignored. This is also happening in the case of erythropoietin, IFN, and streptokinase. Government‘s hampering and slow administrative practices and allocation of insufficient resources have held back the proper operation and expansion of this capable factory... I strongly recommend that we should collaborate more seriously with the private sector and use their efficiency to get the best outcome from such projects... Experience from Pasteur Institute has shown that government is successful in setting direction and supporting R&D but should leave production to the more suitable organisation, competence, and effectiveness of the private sector. I really do hope that this unit is transferred to the private sector, where, under adequate managerial practices and the allocation of sufficient resources the factory realises its massive growth potential. ...From the start it was obvious that under government management this project would encounter deficiencies and progress very slowly. We mentioned this many times. ...[The previous Minister of health] agreed that the government style management practices would not benefit the projects and it was finally decided to hand the projects over to a semi private organization [Social Security Organisation]. By the time Social Security agreed to the take over and we received the approval of the President‘s consultants in industry matters...the government changed again. The new government was new to the whole idea and it took again some time to get the approval for the handover and there were disagreements in finding a takeover partner so the whole process was delayed until the projects were completed. At present we observe again that government administration is not adequate for the operation and maintenance of an industrial factory of this scale and with such high level of technological knowledge...‖ (Interview with biopharma industry expert)