Liability of a Pharmaceutical Company Towards Patients For Clinical Trials

Clinical trials play an essential role for the verification of safety and efficacy of a medicinal product before it enters the market and is broadly accessible for patients. Therefore, the value of clinical trials cannot be overestimated, as they considerably facilitate risk – benefit balance assessment for a new medicine, or reduce the risk of adverse reactions appearing when a product is taken by a larger number of patients. At the same time, it goes without saying that it is necessary to ensure safety of the participants of clinical trials. It is then interesting to consider the scope of liability of a pharmaceutical company towards patients.

According to art. 37j of the Polish Pharmaceutical Law dating from September 6, 2001, a sponsor (in most cases it is a pharmaceutical company) and an investigator (so a doctor responsible for the conduct of a clinical trial) are liable for damages caused by the trial.

Taking into account the fact that a patient does not enter into any contract with an investigator or a sponsor, the liability for damages suffered by a patient is a liability for a tort and not a contractual liability.

Here come the doubts about the prerequisites of the liability of the sponsor and of the investigator. With regard to Polish civil law, the liability for torts is based, in principle, on the prerequisite of a fault. Therefore, liability for damage occurs when the fact that resulted with this damage has been contrary to the legal order. What does this then mean for the liability of a pharmaceutical company which is a sponsor of a clinical trial? Well, if one considers art. 37j being based on the prerequisite of fault, then the pharmaceutical company is liable exclusively when an investigation taken within the framework of the clinical trail, which caused the damage to the patient, has been conducted contrary to legal regulations. To sum up, the compensation for damages suffered by a participant of a clinical trial would be due only when the trial has been conducted without respect to legal provisions, for instance when Good Clinical Practice has been not applied in the course of an investigation. In consequence, the pharmaceutical company would evade liability for damage proving that there was no fault in its activity. For example, when a clinical trial has been conducted correctly and the damage suffered by a patient is a result of an adverse reaction of an investigated drug, it would suffice if a pharmaceutical company proves that the patient was warned that the ADR may occur.

The law envisages however also liability for torts on risk basis, which is independent from the prerequisite of fault. The civil code provides several norms which introduce the liability on the risk basis to Polish law. They concern, in particular, situations of using, for personal interest, a subject or an instrument which carries a relatively high risk for a third party. In the light of the above considerations comes the question whether the liability of a pharmaceutical company is not on a risk basis?

The structure of art. 37j may suggest that the legislator intended to depart from the liability on a fault basis. The interpretation of this provision leads to the conclusion that it does not follow the basic principle of torts law: who, from his or her own fault caused a damage to another person, shall be obliged to give remedies. Instead of that, the liability of a sponsor and of an investigator seems to be on a risk basis. In consequence, the prerequisites of pharmaceutical company’s liability are as follows: fact of conducting a clinical trial and damage suffered by its participant which is in an adequate causal nexus with this trial.

There is no doubt anyway, that the liability of a sponsor and of an investigator is a joint one. It means that the participant of a clinical trial who suffered damage to health is free to choose who is to be claimed for damages. If a patient claimed one of these two persons: a sponsor or an investigator, the one who has been claimed is provided with recourse claim. It must be however noted that art. 37b of the Pharmaceutical Law envisages an obligatory third party insurance for both – sponsor and investigator.

Legal Aspects of Medical Representative

Pharmaceutical company, wishing to increase its market shares must employ a team of trained field workers. Currently, you cannot lead an active promoting campaign, without the participation of representatives, constantly penetrating the health care establishments, on areas specified by the headquarters.

The work the representative carries can be described generally as advertising, namely the transfer of information connected with persuasion, aimed to encourage the purchase or use of a specific product.

Within the meaning of the article 52, paragraph 1 of the Act of 6^th September, 2001, the Pharmaceutical Law (Journal of laws of 2001, No. 126, item 1381 as amended), medicinal products advertising is the activity consisting in the informing or encouraging the use of the product, intended to increase: the number of prescriptions, supply, sale or consumption of medical products.

Taking into consideration the broad definition of product advertising, extremely important for the pharmaceutical companies should be the lawfulness of the actions of their employees in their area of operations. Therefore it is essential, that every representative knew at least legal basis of his activities.

This study is just an extract of the most important – according to the author – rules which a medical representative should follow in his work.

 

Posters, leaflets? Yes, but complete, and only in the waiting room!

 

Advertising targeted to the public, must contain some essential data relating to the product itself (such as name, identification), as listed in the Regulation of the Minister of Health of 21^st November, 2008. It is important that these data were in line with the Summary of Product Characteristics (SPC), and in its absence, with documentation approved in the process of admission. In the advertising there should be a warning, which content was included in the Regulation.

In addition, a medical product advertising in health care establishments can be only displayed in waiting rooms and cannot consist in using audio and audiovisual messages.

 

Advertisement in the media? Yes, but not of a prescription drugs!

 
In the case of advertisements targeted to the public it is prohibited, inter alia, advertising of medical products, which can only be prescribed. This prohibition also applies to products containing narcotic drugs and psychotropic substances, and placed on the lists of reimbursed drugs in accordance with the relevant provisions.

 

Materials for doctors? Yes, but complete!

 

It is important that this form of advertising include the necessary data referred to in the article 12 paragraph 1 of the above – mentioned regulations. In case of medicinal products placed on the lists of reimbursed drugs – the information about the official retail price and the maximum amount of costs incurred by the patient is also essential.

It is extremely important that information provided to individuals in the form of documentation should be fair, up-to-date, verifiable and sufficiently complete to enable customers to make their own assessment of the therapeutic product.

 

A visit to the Doctor? Yes, but first plan it!

 

There is also a need to obtain a prior consent from a manager of the establishment for the meeting with the doctor working there, as well as making an appointment with the interested party. It is important that visiting the persons entitled to issuing prescriptions in their place of work would not impede their work and that it should take place outside their working hours.

 

Samples? Yes, but need a little bit of red tape!

 

The advertising of medical products consisting in providing free samples, can be directed only to people entitled to issuing prescriptions, providing that the person has asked in writing for a sample. The person must keep records and a number of samples of the same product served to the same person may not exceed five packages a year.

Moreover, the sample cannot be larger than the smallest package of that medicinal product distributed on Polish market. The following marking: “Free sample – not for sale” and including the Summary of Product Characteristics is necessary.

 

 

Sponsorship? Yes, but brainy!

 

The sponsorship of promotional meetings, conferences, meetings and scientific congresses for persons authorized to issue prescriptions or persons engaged in the marketing of medical products is acceptable.

In addition, advertising of a medical product may not consist in offering or promising any benefit, directly or indirectly in exchange for the acquisition of a medical product or the provision of evidence that acts from its acquisition.

Prohibited is advertising consisting in giving and promising material benefits, gifts and various facilities, awards, trips and organizing and funding meetings, in which manifestations of hospitality goes beyond the main purpose of the meeting.

It should be however noted, that the ban does not include giving a value not exceeding the amount of 100 polish zloty, connected with medical or pharmaceutical practice, provided with a trade mark of the company or the product.

 

Conclusion

The legal aspects of medical representative is a comprehensive issue, requiring further analysis, taking into consideration the legislation volatility in this matter. The proof may be even the new Regulation of the Minister of Health, part of which is discussed in this article.
What is more, to clarify any doubts, which certainly may arise after reading this article, helpful may also be decisions of the Chief Pharmaceutical Inspector suspending advertisement of  medical products, the European law and solutions adopted in foreign legislation on advertisement of medical products.

 

The Price of Medical Products

The price of medicines are crucial for many groups of interests, above all, the patients. In case of medicines put on the reimbursement list the price instrument is essential also to the State as well as to medicines’ manufactures to whom the proper price is a key factor generating profits for their business. Statistics related to medicines’ prices from Eurostat resources in 2005 show undoubtedly they are at the lowest level among EU countries as well as in European Economic Area (EEA). In the other hand it does not change the fact the share of public funds in refunding is decreasing since 2003. That encroach the patients’ budgets as they pay extra for the refunded medicines.

 

The price of the medical product being paid by patients depends on many factors. Among the most important, they are:

-          legal regulation adopted by the legislator or other bodies issuing regulations;

-          the market mechanism, e.g. stronger competition in a relevant market sector forcing to reduce the price; 

-          sale and distribution method (Internet contra traditional retail);

-          the medicine origin (in relation to whether it comes from parallel import);

-          the role of promotion carried out by pharmacists and doctors;

-          the level of expenditure planned by pharmaceutical companies in their marketing budgets; 

 

The fact is that medical products delivered to patients by mail-order or through parallel import are several or a dozen or so percent cheaper that those purchased in a traditional way. These means of acquiring are in force because of lawmaking judgements of Court of Justice of European Communities, who used to pose a judgements stating that the ban of sale through mail-orders or parallel imports are contrary to the main rule of EU Treaty – free movements of goods.

In order to enable the patient to purchase the medical products at lower price it is essential to strengthen market mechanisms –  higher amount of products being equal in therapeutic effect will force other market player to reduce the price. This issue was stressed out by the European Committee in a preliminary report dated on November 28, 2008 on patent protection of original products and access to generic products market.

 

Basic matter related to medical products price on the most popular patients diseases (e.g. circulatory system) refers to mechanism of setting the price for refunded products. There are two basic mechanisms of medicines price establishing in Europe and somewhere else in the world, so called: fixed price system and free price system. However there are also mixed systems where, like in Great Britain, the price determined under free price system is influenced by various factors limiting expenditure of State Treasury towards refunding.

Nowadays in Poland in regard to refunded medicines the fixed price system is now in force. The minister of health department in co-operation with a minister of finance department determines in a decree what are the fixed prices and the allowable level of margins. Moreover, both the price system and margin are established as maximum thus those leading the medicines business – wholesale or retail – may compete by decreasing prices or margins as well as by other marketing instruments (loyalty programs, commercial discounts, club cards or points card etc.) beneficial to patients.  

Among the latest changes presented by the Ministry of Health in the project of amendment to Pharmaceutical Law Act and several other acts ( including the Act on prices) relating directly to prices establishing rules,  the systems modification has been proposed. The proposal points to introducing fixed price and margin system, whereas the administrative body shall establish the refunded part of a price and a stable rate of margin for wholesale and retail. It is  assumed that shall cause a decrease at the medicines’ prise and  manage to eliminate so called pharmacy tourism, i.e. searching by a patient the pharmacy offering the medicine at the lowest price.

As it is generally believed the project may infringe the constitutional rule of freedom economic activity as well as competition regulations. There is a risk that the proposal will bring not only ambiguous regulations and vague justification to the project, but also the results opposite to those had been expected. The outcomes the governors wish to achieve are able to be realised by means of other instruments, more simple legal mechanisms than those planned in the project of amendment.