Obligations of pharmaceutical companies

Broadly, the pharmacovigilance obligations of companies may be summarised as follows  

The qualified person for pharmacovigilance takes personal responsibility for organisation and management of the pharmacovigilance system within the company. He or she needs to be continuously available and therefore most large companies also nominate a deputy. It is essential that adequately documented procedures are put in place and that a quality management system approach is adopted. 

There are two other important principles for companies. The first is that serious reports should be followed-up and the information gleaned also reported within 15 days. Secondly, companies should proactively search the medical literature to identify published case reports of adverse reactions to their drugs. Assuming they are considered serious, these should also be submitted as expedited reports. 

Prior to authorisation, in relation to products being investigated in clinical trials, ADR reporting requirements are different. The key principles here are that serious and unexpected (as defined by absence from the investigator s brochure) suspected ADRs SUSARs should be expedited, and that such reports should be unblinded for this purpose. Steps should be taken to ensure that personnel directly involved in the trial remain blinded. Companies are required to submit SUSARs both to regulatory authorities and the ethics committee(s) that approved the trial. They must also ensure that all investigators are kept informed about SUSARs so as to meet the key objective of protecting the safety of trial subjects. 

The practice of ADR reporting by companies has many complexities that I have not discussed and which are best learned on-the-job 

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Since then there have been many publications and reviews of the UK yellow card system and spontaneous reporting systems internationally.A summary of the capabilities and limitations of the method is given in Table 15.6. Although these have been discussed in the greatest detail over the past three decades, the obligations that exist for pharmaceutical companies in the reporting of adverse events to the regulatory authorities at both national and international levels make it essential to review them in this chapter. 

A pharmaceutical company is not obliged to supply an imapproved product under the authorised prescriber provisions. If it does supply the specified product, the company must provide reports every six months of the amount of product supplied to authorised prescribers. 

Pharmaceutical companies are now required to report all serious suspected ADRs to the CSM within 15 calendar days of receipt of the original information by the representative or other appropriate employee. Companies are also now obliged to submit reports received from all health professionals... 

In the search for new dmgs, most pharmaceutical companies have abandoned the natural product. Switzerland is a case in point out of twenty start-up and spin-off pharmaceutical companies, seven make use of parallel and combinatorial synthesis, which is much less expensive than the search for bioactive natural products and is free from obligations toward the countries holding the rights for the germ plasm. Only one of the new Swiss conq)anies relies on natural products, merely raw extracts for veterinary use (L EppIatenier 2000). 

Integrity Members or employees of both groups should not allow any physician to be placed in a position where he or she is under any financial or other obligation to a pharmaceutical company or its representative that might or might appear to Improperly influence that physician in the performance of his or her medical duties. 

It is the responsibility of the manufacturer of drug products to ascertain and certify that each component in the finished drug was produced, delivered, and handled in accordance with GMPs. To meet this obligation, pharmaceutical companies perform regular audits at each of its suppliers facilities, an expensive exercise for both. 

They need assurance that the medicines they are offered fulfil these requirements and are supported by information that permits optimal use. The information about and the usage of medicines gets out of date, and there is an obligation on licence holders continually to review their licence with particular regard to safety. Marketing Authorisation Holders (MAH), i.e. pharmaceutical companies, can also change the efficacy claims to their licence, e.g. new indications, extension of age groups, or... 

In replying to these letters, Wakefield (58) defended the clinician s duty to his patients and the researcher s obligation to test hypotheses. For his part, the editor of the Lancet pointed out that the paper had been presented with a commissioned commentary in the same issue peer review had confirmed that the paper merited publication, with suitable revisions and editing, as an early report finally, he considered that the press had presented the information in a balanced way (59). However, it was subsequently discovered that the work had been sponsored by a pharmaceutical company which had not been declared at the time (60). Furthermore, the children who were included in the study had been selected other than at random. Subsequently, 10 of... 

All of the Health Authorities in the Gulf States state quite explicitly that pharmaceutical companies cire obliged to supply a price certificate ong with their submission for the registration approved of a phcirmaceutical preparation. This document must provide the following information ... 

If you are unfamiliar with the dose of the medication, this will need to be checked. The best reference source for this is the British National Formulary or the British National Formulary for Children, or the Summary of Product Characteristics (SPC), which each pharmaceutical company is obliged to produce for each individual medicinal product. 

Additionally the French authorities have implemented specific regulations in order to prevent non-declared taxable activities. According to French law any person or entity that executes a services agreement providing for financial compensation of 3000 or more per year must verify that the service provider (e.g. doctor or pharmacist) complies with tax and social security obligations. The beneficiary of this service (e.g. the pharmaceutical company) must request evidence of compliance with these regulations every six months for the duration of the contract. The documentation required is listed in Article R.324-4 of the French Labor Code. If a beneficiary of a service (e.g. the pharmaceutical company) fails to do this they may themselves be liable for the payment of these taxes/ ... 

Recently, as the task force was deliberating, the question of whether such a journal should be created was posed to a larger audience of computational chemists. The task force was well aware of its obligation to solicit the opinions of the wider community of computational chemists. Comments on the proposal of a new journal were invited by a member of the task force, George W. A. Milne, editor of the ACS Journal of Chemical Information and Computer Science. He posted a request for input on the Ohio Supercomputer Center computational chemistry electronic bulletin board. This forum has an international audience of over 1000 scientists interested in computational chemistry. In addition, at least one other survey was done in-house at a pharmaceutical company where molecular modeling is being used by over 100 scientists. 

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