The pharma, medtech, lab-tech industry continues to lead the fight against corruptive business practices

The research-based pharmaceutical industry, Swedish Medtech, Swedish Labtech and the Swedish Association of Local Authorities and Regions have adopted a revised agreement concerning collaboration between themselves and the health service.

This agreement aims to achieve greater transparency but also a more moderate conduct in the collaboration between the industry and their counterparts in the health service. There has also been a call for more clarity with regard to each party’s responsibilities in connection with, for instance, training activities for health care personnel.

In direct relation to this, the so called 50/50 rule which enables a pharmaceutical company to finance 50 % of the participating personnel’s costs for travel, room and board will no longer apply after 1 January 2015. Consequently, the company will no longer have to document approval from the employer concerning participation in such an activity.

The agreement applies not only to employees but also to senior officers in the organization. The industry’s ability to offer modest meals is clearer as well as the industry’s opportunities and obligations to offer product and service information; sponsoring of meetings arranged by the industry, the health service or third parties. It also clarifies what applies in relation to market surveys, public procurement and donations.

The agreement covers not only the pharma industry but also the medtech and labtech industry. It is incumbent on each party to ensure compliance by its members and to implement a self-regulatory system for this purpose. The parties will review the rules once a year and revise and amend them if necessary.

The agreement entered into force on 1 January 2014. It is to be ratified by each regional authority in the months to come.

Five core principles

There are five core principles for collaboration between the industry and the healthcare sector. The principles of Benefit – collaboration should always be based on the activities of health service and on the needs of the patients. An activity must be clearly connected to the company’s business operations. A mutual benefit perspective must be applied. Transparency – Collaboration should always be open and transparent in accordance with the agreement, applicable legislation, codes of conduct and policies.

Proportionality – The obligations of a party in a collaboration must be proportionate to the other’s. All forms of compensation should be proportionate, reasonable and correspond to the market value of the service performed Moderation – All activities sponsored by a pharmaceutical company should be permeated by moderation. This means that the benefit must not be such that it may influence the behavior of the recipient. The collaboration must not result in undue influence and must not jeopardize the independence of the health service.

Documentation – all forms of collaboration between the industry and the health service where any form of compensation for costs occurs, regardless if it accrues to an individual employee or groups of employees or at an operative level must be documented through decisions, contracts or agreements. Records and relevant documents, for instance invoices, must be kept.

General rules which should always be observed

The basic rule is that a company may not offer benefits contrary to the agreement or its intentions and employees in the health service may not request such benefits. In relation to meetings arranged by, or in collaboration with, companies the company may offer modest meals. Such hospitality may include alcohol provided it is moderate and alcohol can only be served in connection with meals. Spirits should never be offered. Non-alcoholic beverages should always be offered. Recreational activities may not be financed by a company or requested by health service employees. Travel arrangements should, where possible, be arranged in economy class. Travel time may not exceed the length in time of the meeting. It is not permitted to bring along a spouse, partner or friend. The venue selected for the arrangement should be reasonable in relation to the purpose of the meeting. Leisure resorts in season and places known for their exclusivity should be avoided, as well as locations hosting or in the vicinity of major international events. Arrangements outside Sweden including the Öresund-region (Denmark) may only be chosen if a majority of the participants come from other countries than Sweden.