Swiss biotech industry highlights

Transparency is the key to the creation of confidence in relations with the general public and patients. That is why the European pharmaceutical industry intends in future to disclose the pecuniary benefits provided between the pharmaceutical industry and stakeholders in the healthcare sector.

On 24 June 2013, the European Federation of Pharmaceutical Industries and Associations (EFPIA) adopted the new EFPIA Disclosure Code. On that basis, scienceindustries as the responsible member association of EFPIA in Switzerland drew up the Pharma Cooperation Code (PCC) which entered into force in January 2014. The partner associations Intergenerika, Interpharma and vips have also subscribed to the PCC.

What commitment have the PCC signatory companies made?
With effect from 2016, the signatory companies will disclose each year on their websites accessible to the public the  pecuniary benefits which they granted in the previous year (beginning with 2015) to professionals (primarily physicians and pharmacists) as well as healthcare organizations (in particular hospitals and research institutes).

Which benefits are disclosed?
The term pecuniary benefits as defined by the PCC means remuneration granted either directly or indirectly in connection with pharmaceuticals for human medicine available on prescription only. The disclosure includes payments made e.g. for consultancy and the provision of services, financial support for research and development in the healthcare sector and cost contributions for the attendance of professionals at events.

There are few exceptions from the obligation to disclose pecuniary benefits, e.g.:
• normal commercial compensation for professionals when pharmaceuticals are ordered and delivered
• delivery of pharmaceutical samples without payment to professionals within the limits of the official
   recommendations
• information and training materials of modest value
• payment for meals (including beverages)

How is disclosure effected?
To achieve a high degree of transparency, disclosure should take place individually, i.e. naming the recipients in person.
This requires the consent of the persons or organizations concerned to such disclosure. For this purpose, the cooperation agreements between the companies and these professional persons and organizations must be supplemented by suitable consent clauses. The companies are currently in contact with these stakeholders for that reason.

[Source: https://en.scienceindustries.ch/involvement/pharma-code-and-pharma-coope…

Legal provisions on research on humans can be found on several federal acts, the most important being:

Federal Act on Research involving Human Beings (Human Research Act, HRA)

The legislation on research involving humans came into force on 1 January 2014. Besides the Human Research Act (HRA), the legislation includes three ordinances:

• Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance; ClinO)
• Ordinance on Human Research with the Exception of Clinical Trials 
  (Human Research Ordinance, HRO)
• Ordinance on Organisational Aspects of the Human Research Act
  (HRA Organisation Ordinance, OrgO-HRA)

The HRA regulates research involving humans (in particular clinical trials), research on human cadavers, embryos and foetuses, and research involving biological material and health-related personal data. All of these research projects must be authorised by an ethics committee. Clinical trials also need to be registered. The overall aim of the new act is to simplify certain processes: it standardises authorisation and registration procedures and reduces the administrative burden for research projects involving low risk for the participants.

The new legislation aims to protect the dignity, privacy and health of human subjects of research. The law also aims to create appropriate conditions for research involving humans, help to improve the quality of this research and foster greater transparency in this area.

Further information on the law and the main changes it involves can be found on the kofam (Coordination office for research involving humans) website: www.kofam.ch

The competent authorities for research on humans in Switzerland are the Swiss Federal Office of Public Health (SFOPH) and Swissmedic.

The Nagoya Protocol on Access and Benefit-Sharing, which was negotiated within the framework of the Convention on Biological Diversity, regulates access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation. It therefore supports the implementation of the third objective of the Convention on Biological Diversity, and contributes towards the preservation of biodiversity and the sustainable use of its components.

Switzerland has ratified the Nagoya Protocol on 11 July 2014. The Nagoya Protocol and the amendments of the Natural and Cultural Heritage Protection Act (NCHA) came into force on 12 October 2014. The Nagoya Ordinance (NagO) came into force on 1 February 2016. 

Together with the Nagoya Protocol and the provisions in the Federal Act on the Protection of Nature and Cultural Heritage (NCHA it forms the basis for the legal use of genetic resources from other countries. The Nagoya Ordinance (NagO) also regulates the access to genetic resources in Switzerland. The Nagoya Ordinance substantiates the provisions in the Nature and Cultural Heritage Act  for the implementation of the Nagoya Protocol in Switzerland and thus ensures greater legal certainty.

The Nagoya Ordinance defines obligations and responsibilities when doing research on genetic resources from Switzerland and other Nagoya parties, regardless if research is performed in academiy or industry.

For more information, consult:
www.sib.admin.ch/en/nagoya-protocol/implementation-in-Switzerland