Pharmaceutical Industries
M. Abdelaziz TAZAÏRT |
- M. Abdellah FELLA: Ministry of Industry e
- M. Malek LAÏDOUNI: Ministry of Participations and Investments Promotion
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Preamble
Definition of the pharmaceutical product: « in the sense of the law, pharmaceutical products include medicines, biological reagents, officinal chemicals, galenical products, dressing objects and all other products necessary for human and veterinary medicine » (article 169 law 85-05).
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Inventory and statement
- About a hundred of producers (manufacturers and conditioners),
- More than 70 projects in progress,
- A national needs coverage at the level of 22 % in value,
- 78 % of the market covered by the import, that is a value of more than one Thousand million USD,
- Generics market shares of 25 %.
- A lack of pharmaceutical product policy,
- A lack of dialogue between sector professionals and authorities,
- An ill-adapted regulatory framework.
The pharmaceutical industry has a strategic nature of public health and consequently has to benefit from the State commitment and support.
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Recommendations
1.1. Definition and implementation
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Registrations:
- Periods: 120 days,
- Reciprocity in terms of registration fees with foreign countries,
- Strengthening of local producer right as far as registration is concerned.
- Repayment: consistency with registration and reference rate,
- Exemption from Customs duties and VAT of all pharmaceutical products inputs,
- Exemption from Customs duties and VAT of all pharmaceutical products inputs,
- Coverage of expired drugs in the country of origin and regularization of physical liabilities.
1.2. Promotion of the national production
- Protection measures of the national production in accordance with EU - WTO association agreements,
- Import suspension of products made locally during a probationary period,
- To make partnership operations easier (transfer of royalties),
- Policy of generics in particular for the coverage of prevailing pathologies and life time extension,
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Implementation of a framework for the FDI:
- Direction towards high technology projects (biotechnology),
- Accession to foreign markets,
- To Redeem the Central Pharmacy of Hospitals in its initial prerogatives and associate it with the promotion of local production.
2. Research promotion
- Development of the partnership universities - companies:
- Academics integration in boards of directors, scientific councils etc.
- Taking in charge operators constraints as the subject of thesis or dissertation by academics,
- To allow the academics to take up posts in companies at the same time as the academic office,
- The company can be used as practice period ground,
- Promotion of research and development activity: integration of the various essential qualifications that is to say: chemists, biologists, pharmacists doctors etc. …
- Development of the partnership in research and development field,
- Revitalize the activities of vaccines and serum research and production by the Institut Pasteur, on its own or in partnership,
- Promotion of the innovation by taking in charge the results of the Algerian inventors (forsaken at the moment).
3. Promotion of the human factor
- Industrial Pharmacy Certificate to be developed,
- Training for pharmaceutical industry professions, by the creation of a training centre specialized for the needs of the field,
- Strengthening of operators managerial capabilities for a better competitiveness (organization of professional trainings, recruitment of new qualifications, and use of modern methods of communication).
4. Creation of Medicines Agency
- Quality control of the pharmaceutical product,
- Pharmacovigilance and medical devices vigilance,
- Bioequivalence and clinical tests,
- Pharmaceutical products registration,
- Promotion and advertisement monitoring,
- Inspection of the various concerned groups in the pharmaceutical product chain,
- Approval and inspections of production units,
- Publication of the economic information (statistics of the Ministry of Health, Population and Hospital Reform. MSPRH).
5. Creation of a consultation council
- Participation in the great decisions concerning all the measures likely to have an influence on the pharmaceutical product policy.
- Composition: Ministry of Health / Ministry of Employment / Ministry of Industry / Ministry of Finance / Ministry of Trade / Ministry of Higher Education / Medicines Agency / Manufacturers
The national producers offer to satisfy 65 % of the market needs by the year 2012, within the framework of the application of these recommendations.
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