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Moti­on Ruiz (17.3170): Bio­banks: a legal frame­work to safe­guard bio­me­di­cal rese­arch and pati­ent protection

Moti­on Ruiz (17.3170): Bio­banks: a legal frame­work to safe­guard bio­me­di­cal rese­arch and pati­ent protection

Rejec­tion reque­sted, not yet addres­sed in Council.

Sub­mit­ted text

The Fede­ral Coun­cil is ins­truc­ted to draw up a Draft law on bio­banks through which the pro­tec­tion of par­ti­ci­pan­ts, free­dom of sci­ence, and public health are ensu­red and inter­na­tio­nal ethi­cal prin­ci­ples and human rights are respec­ted. This law should ser­ve as Basis for net­wor­king popu­la­ti­on-based bio­banks in Switz­er­land and for the Estab­lish­ment of a natio­nal popu­la­ti­on-based bio­bank ser­ve. The law should also defi­ne the mini­mum requi­re­ments that all bio­banks in our coun­try, both public and pri­va­te, would have to meet. In this way, Switz­er­land secu­res its place in inter­na­tio­nal research.

Justi­fi­ca­ti­on

In order for us to address the chal­lenges facing the heal­th­ca­re system, the Coll­ec­ting and pro­ce­s­sing lar­ge amounts of per­so­nal data and human samples essen­ti­al. For this pur­po­se, exten­si­ve popu­la­ti­on-based bio­banks must be crea­ted. Bio­bank means the orga­ni­zed coll­ec­tion of human samples and the asso­cia­ted data.

Num­e­rous fede­ral laws that have been pas­sed recent­ly or will be pas­sed soon refer to cer­tain chal­lenges we face in con­nec­tion with bio­banks: HFG, GUMG, KRG, EPDG, DSG etc.. Howe­ver, none of the­se enact­ments pro­vi­des a com­ple­te ans­wer to the que­sti­ons rai­sed by biobanks.

In this con­text, the adop­ti­on of a fede­ral law would make it pos­si­ble to estab­lish the gene­ral frame­work for bio­banks. It would also gua­ran­tee fun­da­men­tal rights and free­doms and estab­lish mini­mum requi­re­ments in terms of qua­li­ty and safe­ty stan­dards. Such a mea­su­re would be an indis­pensable step to address the justi­fi­ed con­cerns of the popu­la­ti­on, while pro­mo­ting research.

Many count­ries have alre­a­dy anti­ci­pa­ted this sci­en­ti­fic and public health need. In this way, the­se count­ries are gai­ning a head start in rese­arch and in the explo­ita­ti­on of their results. Switz­er­land, who­se cut­ting-edge rese­arch in bio­me­di­ci­ne is inter­na­tio­nal­ly reco­gnized, is lag­ging behind in this area. Admit­ted­ly: Num­e­rous initia­ti­ves exist to net­work our country’s bio­banks, for exam­p­le the Swiss Bio­ban­king Plat­form. The phar­maceu­ti­cal indu­stry also coll­ects num­e­rous samples as part of its own rese­arch. Howe­ver, the­re is a lack of a clear legal frame­work to pro­mo­te the­se measures.

State­ment of the Fede­ral Coun­cil of June 2, 2017

The Fede­ral Coun­cil is awa­re that rese­arch with bio­lo­gi­cal mate­ri­al and health-rela­ted per­so­nal data plays an important role in medi­ci­ne. It reco­gnizes the importance of bio­banks for bio­me­di­cal rese­arch and thus for Switz­er­land as a rese­arch loca­ti­on. At the same time, he also sees the chal­lenges, par­ti­cu­lar­ly with regard to the pro­tec­tion of per­so­na­li­ty, which accom­pa­ny the tech­no­lo­gi­cal deve­lo­p­ments in the field of data processing.

Spe­ci­fic bio­ban­king laws exist in Fin­land and Bel­gi­um, for exam­p­le. In many other count­ries, the pro­tec­tion of indi­vi­du­als par­ti­ci­pa­ting in rese­arch pro­jects is regu­la­ted by gene­ral decrees, usual­ly via data pro­tec­tion laws.

Many aspects that a “bio­banks law” would cover are alre­a­dy regu­la­ted by the Fede­ral Law on Rese­arch Invol­ving Human Sub­jects (Human Rese­arch Act, HFG, SR 810.30). Its pri­ma­ry objec­ti­ve is to pro­tect the dignity and per­so­na­li­ty of the par­ti­ci­pa­ting indi­vi­du­als. In detail, the law and the imple­men­ting legis­la­ti­on pre­scri­be the con­tent of the infor­ma­ti­on and the form of con­sent of per­sons who pro­vi­de samples and data to a bio­bank for rese­arch pur­po­ses. The right to infor­ma­ti­on about results is also sti­pu­la­ted, as is the encryp­ti­on or decryp­ti­on and anony­mizati­on of samples and data. In addi­ti­on, it con­ta­ins requi­re­ments for the sto­rage of samples and data. With the HRA, Switz­er­land has a com­pa­ra­tively com­pre­hen­si­ve regu­la­ti­on of human research.

Howe­ver, the­re are no spe­ci­fic licen­sing requi­re­ments for the ope­ra­ti­on of bio­banks.after a cor­re­spon­ding pro­po­sal in the preli­mi­na­ry draft of the Human Rese­arch Act was view­ed nega­tively by rese­arch and indu­stry cir­cles. This was also on the grounds that the speed of tech­ni­cal deve­lo­p­ments in the field of bio­banks is very high and the­r­e­fo­re self-regu­la­ti­on was desi­red. At the inter­na­tio­nal level, the Tai­pei Decla­ra­ti­on was adopted by the World Medi­cal Asso­cia­ti­on in Octo­ber 2016. By pri­ma­ri­ly addres­sing phy­si­ci­ans as well as bio­bank employees, it stri­ves for self-regu­la­ti­on of bio­banks. The Decla­ra­ti­on con­ta­ins gui­de­lines on pati­ent rights, orga­nizati­on and ope­ra­ti­on of biobanks.

The Fede­ral Coun­cil is of the opi­ni­on that the­re is curr­ent­ly no need for sta­tu­to­ry regu­la­ti­on. On the one hand, the­re are no indi­ca­ti­ons from enforce­ment that the pro­tec­tion requi­re­ments of the HRA are insuf­fi­ci­ent. On the other hand, it has been shown that both the estab­lish­ment and ope­ra­ti­on of bio­banks and the coope­ra­ti­on of indi­vi­du­al bio­banks at natio­nal level, e.g. within the frame­work of the Swiss Bio­ban­king Plat­form, are pos­si­ble even wit­hout a cor­re­spon­ding Bio­ban­king Act.

As part of its legal man­da­te (Art. 61 HRA), the Fede­ral Office of Public Health is curr­ent­ly revie­w­ing the effec­ti­ve­ness and appro­pria­ten­ess of the HRA. In doing so, it is also exami­ning the spe­ci­fi­ca­ti­ons for the coll­ec­tion and fur­ther use of samples and data. The eva­lua­ti­on will iden­ti­fy any need for action, also with regard to the regu­la­ti­on of bio­banks. The Fede­ral Depart­ment of Home Affairs will report to the Fede­ral Coun­cil at the end of 2019 and sub­mit pro­po­sals for action. Based on this and on fur­ther expe­ri­ence in deal­ing with bio­banks, the Fede­ral Coun­cil will deci­de whe­ther or not the­re is a spe­ci­fic need for regu­la­ti­on, par­ti­cu­lar­ly in the area of rese­arch with bio­lo­gi­cal mate­ri­al and health-rela­ted per­so­nal data.

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