UCB SA - BNP Paribas Fortis

the objectives to ensure adequate interpretation of the safety profile of the drugs and the protection of
the patients. Each identified or reported adverse drug reaction is analyzed and interpreted by a team of
physicians and scientists and is reported within determined timelines to the appropriate regulatory
authorities in various countries. Any adverse events observed for drugs under development are also
notified to clinical investigators, institutional review boards and independent ethics committees (as
appropriate). Furthermore, the pharmacovigilance department endeavours to ensure the timely
preparation and submission of aggregate periodic reports of any such adverse drug reactions. These
aggregate reports include non-clinical safety data, clinical safety data and an evaluation of the riskbenefit
profile of the individual product.
In the course of the life cycle of a product, regulatory authorities also demand the preparation of risk
management plans or risk evaluation and mitigation strategies. Such plans and strategies set out UCB’s
approach to identifying, monitoring and mitigating any potential safety observations. The UCB clinical
safety and pharmacovigilance department undertakes the preparation, follow-up and reporting of such
observations, such as Phase IV, pharmaco-epidemiological and observational studies or registries, as
detailed in such plans and strategies.
Furthermore the UCB clinical safety and pharmacovigilance department contributes to the accuracy of
the description of any adverse effects and potential safety observations in product-related information
provided to patients and healthcare professionals.
Marketing of Products
After a product has reached the market, it will be subject to regulatory restrictions on advertising,
promotion and distribution. These restrictions apply to over-the-counter and prescription drugs and also
address the interaction between pharmaceutical companies and healthcare professionals. The type and
degree of these regulatory restrictions vary from country to country. Many countries provide for varying
degrees of restrictions on granting benefits or product samples to healthcare professionals. Some
countries impose restrictions on the involvement of pharmaceutical companies in meetings with
healthcare professionals. The marketing and distribution of the UCB Group’s products is also subject to
general anti-corruption and unfair competition regulations. The UCB Group has adopted a broad code
of conduct of the business setting out certain principles in relation to business practices which are
further extended in UCB’s guidelines and standard operating procedures to comply with such legal,
regulatory, ethical and other restrictions. It has also implemented a programme which provides for the
administration and supervision of its compliance guidelines as well as the related training of its
employees.
(b) Manufacturing
(c) Pricing
UCB Group and its toll manufacturers’ production facilities require regulatory approval and are subject
to periodic inspections. The manufacturing of UCB Group’s products is subject to extensive
governmental regulations which address facilities, equipment, manufacturing processes, product
specifications, quality control and good manufacturing practices.
In most of the jurisdictions in which the UCB Group sells its products, it is subject to price and
reimbursement control by governments or private insurance companies. Price and reimbursement
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