Pharmaceutical companies obligations

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. 

As noted elsewhere in this volume, pharmaceutical companies have slowly come to recognize that they have social responsibilities that must be addressed beyond those associated with R D output. Multinational pharmaceutical corporations have a genuine desire to serve public health needs but are constrained by their obligation to shareholders and other factors. All companies aspire to be good corporate citizens in the communities and countries in which they operate and with the populations in which their products are used. 

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 ... 

Furthermore, if the pharmaceutical companies use any unusual (highly specific) equipment for analytical purposes, the Health Authority will request that the pharmaceutical company supply this in order to complete their investigations. Some GCC countries such as Saudi Arabia and Jordan do this and companies have no alternative but to agree and oblige. 

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/ ... 

European dimension can be summarized as obligations for Regulatory Authorities and obligations for the pharmaceutical company holding a marketing authorization (MA) ... 

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. 

In most countries pharmaceutical companies have legal obligations to submit spontaneous adverse reaction reports (see Chapter 5) and these are entered onto the national database. There is some variation between countries as to the proportion of reports which come via the industry (e.g. a large majority do so in Germany and the USA but the proportion is less in the UK). There is a potential for duplication of reports which a clinician submits to both industry and agency and also because more than one clinician may report the same case. A systematic approach to screening databases for duplicates is required and this task has become more difficult in recent years as confidentiality restrictions have increased. 

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