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Un­cer­tain times, an evolving leg­al frame­work: man­aging risks and en­sur­ing so­cial re­spons­ib­il­ity in the life sci­ences & health­care sec­tor The risks of AI in the fu­ture of life sci­ences came un­der the mi­cro­scope at a land­mark leg­al For­um in Septem­ber.Health­care is ra­cing ahead in ad­opt­ing new tech­no­lo­gies across drug dis­cov­ery, de­vel­op­ment, man­u­fac­tur­ing and sup­ply chain but ex­perts pre­dict a tail-whip of dis­putes and con­tract fric­tion.Di­git­al trans­form­a­tion has the po­ten­tial to im­prove every as­pect of health­care and the pharma in­dustry but it also im­pacts data pro­tec­tion, IT se­cur­ity, con­tract design, li­ab­il­ity and reg­u­la­tion.The an­nu­al CMS Glob­al Life Sci­ences and Health­care For­um brought to­geth­er high-level in­dustry and leg­al ex­perts to dis­cuss sec­tor in­tel­li­gence and best prac­tice as well as is­sues ran­ging from cy­ber breaches and crypto­cur­rency wrangles to fall-outs over trade secrets and in­tel­lec­tu­al prop­erty (IP).“AI of­fers amaz­ing op­por­tun­it­ies to ad­vance life sci­ences and ush­er in trans­form­at­ive medi­cine such as cell and gene ther­apy, im­proved dia­gnostics and ana­lyt­ics but it also comes with con­cerns as leg­al and con­trac­tu­al risks are still be­ing un­der­stood and eval­u­ated,” says Nick Beck­ett, Glob­al Co-Head of CMS Life Sci­ences & Health­care Sec­tor Group“Sci­ence and tech­no­logy are mov­ing for­ward very quickly but we are find­ing that the de­tail and strategy of what to do to mit­ig­ate risks or re­solve them is lag­ging be­hind. These are crit­ic­ally im­port­ant is­sues that com­pan­ies need to ad­dress and the For­um ex­amined the im­plic­a­tions and solu­tions.”AI is boom­ing and a re­cent re­port by ana­lysts Grand View Re­search fore­cast that the glob­al AI in health­care mar­ket will grow from its cur­rent value of $10.4 bil­lion at a com­pound an­nu­al growth rate (CAGR) of 38.4% from 2022 to 2030. AI is fast be­com­ing a sig­ni­fic­ant ele­ment of every as­pect of health­care and leg­al de­part­ments and busi­ness units are be­ing chal­lenged to re­spond.The For­um, which was held in Brus­sels and on­line on Thursday, Septem­ber 29, had a packed agenda cov­er­ing tech­no­logy trans­form­a­tion, En­vir­on­ment­al, Sus­tain­ab­il­ity and Gov­ernance, sup­ply chain dis­rup­tion, reg­u­lat­ory frame­works and the chan­ging com­mer­cial land­scape.The scale of chal­lenge was evid­enced in the re­cent CMS Tech­no­logy Trans­form­a­tion: Man­aging Risks in a Chan­ging Land­scape re­port which re­vealed that 56% of cor­por­ate coun­sel and risk man­agers ex­pect an in­crease in AI-re­lated dis­putes, while 50% be­lieve that the use of AI tech­no­lo­gies will lead to risks and dis­putes that can­not cur­rently be fore­seen.Dis­putes will be driv­en by is­sues arising from IP and trade secrets, the use of AI, smart con­tracts, crypto­cur­ren­cies and cloud ser­vices, they be­lieve.“Or­gan­isa­tions are likely to see new types of risks and dis­putes emerge from the use of new tech­no­lo­gies such as AI and crypto­cur­ren­cies. Many busi­nesses are play­ing catch-up in un­der­stand­ing the risks as­so­ci­ated with these new tech­no­lo­gies,” says Lee Gluyas, Part­ner, CMS. “Whilst no busi­ness can elim­in­ate risks com­pletely, those that think ahead, plan early and act­ively man­age risk will give them­selves a sub­stan­tial ad­vant­age.”Fea­tured key­note speak­ers from the United Na­tions Health and De­vel­op­ment Team, gen­er­al coun­sel from lead­ing pharma com­pan­ies, Bo­ston Con­sult­ing Group, fin­an­cial ser­vices mul­tina­tion­al Aon and CMS sec­tor spe­cial­ists.

Di­git­al trans­form­a­tion in life sci­ences is cre­at­ing op­por­tun­it­ies to counter health­care’s most in­tract­able prob­lems from treat­ing rare dis­eases to ac­cel­er­at­ing dia­gnostics and re­du­cing treat­ment back­logs.But tech­no­lo­gic­al ad­vances are out­strip­ping le­gis­lat­ive and reg­u­lat­ory frame­works giv­ing rise to a land­scape strewn with is­sues over data, pri­vacy and IP, the re­cent CMS Glob­al Life Sci­ences & Health­care For­um 2022 heard.“Tech­no­logy change ob­vi­ously brings with it risks in im­ple­ment­a­tion and new uses of tech­no­logy and new reg­u­la­tion and le­gis­la­tion brings new risk,” Jeremy Mash, part­ner at CMS Lon­don, told del­eg­ates.AI is a po­tent force in life sci­ences with ma­chine learn­ing and pa­tient data open­ing up new op­por­tun­it­ies to re­volu­tion­ise health­care and re­lieve sys­tems bogged down by la­bor­i­ous pro­cesses and shrink­ing budgets.The ad­vances are wel­comed across life sci­ences and di­git­al has been en­shrined in most na­tion’s health sys­tem plan­ning but some fun­da­ment­al prin­ciples such as who owns or is re­spons­ible for pa­tient data, new routes to treat­ments and the con­sequences of mis­takes have yet to be fully tested.“There are situ­ations where you can see that evolving in­to risk and leg­al prob­lems,” ad­ded Jeremy. “There is in­creas­ing use of le­gis­la­tion in the space and there is con­cern about where it is go­ing to lead. There are a lot of data is­sues about quite what the ‘black box’ is do­ing and you can see people start­ing to raise con­cerns about how their data is be­ing used.“There is also a lot talk about who is li­able if that AI does not work. Is it the per­son who im­ple­men­ted it or the per­son de­signed it?”CMS ex­amined the emer­ging is­sues in its Tech­no­logy Trans­form­a­tion re­port, which sur­veyed 510 seni­or coun­sel and risk man­agers across sec­tors and dis­covered a range of pre­pared­ness and safe­guards.It iden­ti­fied that IP is­sues rep­res­ent 65% of ex­pec­ted fu­ture tech­no­logy dis­putes, ob­served Jane Hol­ly­wood, part­ner at CMS Lon­don and pat­ent at­tor­ney. She said the ex­ist­ing risk man­age­ment sys­tems for identi­fy­ing, ana­lys­ing, re­view­ing, mit­ig­at­ing and mon­it­or­ing IP risk may need stiff­en­ing.“It's one thing to have con­trac­tu­al ob­lig­a­tions and train­ing for your people gov­ern­ing how you pro­tect your IP and not mis­use third party IP,” she told the For­um, in Brus­sels. “But it's quite an­oth­er to en­sure that your pro­ced­ures re­main ad­equate while you're op­er­at­ing in a world of ma­chine learn­ing al­gorithms and AI fa­cil­it­ated de­cision mak­ing.”She ad­ded: “The IP sys­tem does not evolve as quickly as tech­no­logy ad­vances and there­fore we can have chal­lenges ob­tain­ing pro­tec­tion for new tech­no­lo­gies. We've seen this very much with AI and di­git­al health tech­no­lo­gies where pat­ent pro­tec­tion can be dif­fi­cult to get.”She said that identi­fy­ing own­er­ship and cap­tur­ing de­vel­op­ments in a fast-mov­ing sec­tor where col­lab­or­a­tion and joint ven­tures are com­mon can also gen­er­ate dis­putes.“Big Pharma is in­creas­ingly part­ner­ing with di­git­al health com­pan­ies for drug dis­cov­ery and pa­tient en­gage­ment and clin­ic­al tri­al auto­ma­tion and, again, there's a lack of clar­ity about who owns the data that's gen­er­ated from these part­ner­ships so this is also likely to lead to dis­putes in the fu­ture,” said Jane.To read the full sur­vey, vis­it Tech­no­logy Trans­form­a­tion re­port.

The me­dia sec­tor is known to be highly com­pet­it­ive, with that com­pet­i­tion driv­ing in­nov­a­tion. Older me­dia busi­nesses have had to grapple with dis­rupt­ive new entrants. And those new entrants are con­stantly work­ing to de­liv­er bet­ter and more en­ga­ging con­tent and user ex­per­i­ences to main­tain their ad­vant­age. Di­git­isa­tion has changed how me­dia com­pan­ies in­ter­act with their audi­ence in ways we could not have ima­gined just a few years ago, but this comes with risk.This re­port is a deep dive in­to the data first pro­duced for the re­port Tech­no­logy Trans­form­a­tion: Man­aging Risks in a Chan­ging Land­scape. This saw over 500 cor­por­ate coun­sel and risk man­agers sur­veyed from mul­tiple in­dus­tries across the world. Here we look in de­tail at the 75 re­spond­ents from the me­dia sec­tor, and their per­spect­ives on the risks as­so­ci­ated with busi­ness-crit­ic­al tech­no­lo­gies, in­clud­ing emer­ging tech­no­lo­gies. What did we find? Me­dia is a dy­nam­ic sec­tor and can be an early ad­op­ter of many nov­el tech­no­lo­gies as com­pan­ies push for com­pet­it­ive ad­vant­ages to cre­ate and sat­is­fy cus­tom­er de­mand. As we look to the fu­ture, the sec­tor does seem un­der­prepared in some areas, which is a po­ten­tial cause for con­cern.Down­load the Tech­no­logy Trans­form­a­tion me­dia sec­tor re­port now to read aboutThe prin­cip­al drivers in the ad­op­tion of busi­ness-crit­ic­al tech­no­logy in the me­dia sec­tor­Con­fid­ence in man­aging tech-re­lated risks among seni­or me­dia ex­ec­ut­ivesFu­ture threats from new tech­no­lo­gies like AI and block­chain­Which plans and pro­cesses me­dia com­pan­ies are put­ting in place to pro­tect tech in­fra­struc­ture­Cul­tur­al bar­ri­ers to man­aging tech risks in the me­dia sec­tor­Preferred ap­proaches to dis­pute res­ol­u­tion in the me­dia sec­tor

The United Na­tions has pledged to use its pur­chas­ing fire­power to ac­cel­er­ate sus­tain­ab­il­ity along the health­care sup­ply chan­nel and called on the leg­al sec­tor to sup­port its ef­forts.Law­yers are crit­ic­al to es­tab­lish­ing strong reg­u­lat­ory frame­works and provid­ing con­trac­tu­al guid­ance that would al­low green­er and more equit­able prac­tices to flour­ish, said a seni­or UN ex­ec­ut­ive.Ian Milimo, pro­ject man­ager for the United Na­tions De­vel­op­ment Pro­gramme’s re­gion­al hub for 128 na­tions, told the CMS Glob­al Life Sci­ences & Health­care For­um 2022, that the or­gan­isa­tion would use its $6 bil­lion of pur­chas­ing power to lever­age im­prove­ments in health­care.He used his key­note ad­dress to high­light that, if the health­care sec­tor were a coun­try it would be the fifth largest emit­ter of car­bon, while also prais­ing col­lab­or­a­tions with leg­al ex­perts that em­powered coun­tries, health­care pro­viders and sup­pli­ers to pur­sue car­bon zero am­bi­tions.“We need to strengthen our con­tracts for goods that we pro­cure for ser­vices.  We don't have that ex­pert­ise, you have that ex­pert­ise, and this is an open call for you to join us in mak­ing sure that we are cham­pi­on­ing sus­tain­able de­vel­op­ment,” he  told the For­um of in­vited guests from leg­al, fin­an­cial and health­care sec­tors.“We need law­yers to sens­it­ise cit­izens on their rights and re­spons­ib­il­it­ies with re­gards to cli­mate. We need your sup­port, we need your ex­pert­ise, we need your tech­nic­al abil­ity to en­sure that gov­ern­ments are sup­por­ted to have a win-win situ­ation in terms of sus­tain­able de­vel­op­ment.”Leg­al acu­men will be needed to en­hance ac­cess to tech­no­logy, en­sure pri­vacy and se­cur­ity, es­tab­lish reg­u­lat­ory frame­works and em­power con­tract design across the health­care sup­ply chain. This ex­pert­ise will un­der­pin the United Na­tions Sus­tain­able Pro­cure­ment in the Health Sec­tor (SPS) pro­gramme which aims to en­cour­age in­dustry, man­u­fac­tur­ers and sup­pli­ers to cham­pi­on sus­tain­ab­il­ity.The UN’s 17 Sus­tain­able De­vel­op­ment Goals in­clude health­care where a com­plex land­scape of law and reg­u­la­tions de­mands leg­al skills across areas such as In­tel­lec­tu­al Prop­erty, risk man­age­ment, AI tech­no­logy dis­putes and eco­nom­ic and so­cial re­spons­ib­il­it­ies.Law­yers are in­creas­ingly be­ing called upon to de­vel­op policies, reg­u­la­tions and laws to pro­tect the en­vir­on­ment and pub­lic health, and have a pos­it­ive im­pact help­ing emer­ging na­tions to de­vel­op sus­tain­able prac­tices.“We need to make sure that we wake up to this crisis that we're fa­cing and be­gin to ad­dress those things that are with­in our means and it's very good that we are speak­ing to law­yers be­cause that part­ner­ship is very im­port­ant,” ad­ded Mr Milimo.“We need lead­er­ship from our politi­cians. We need lead­er­ship from our church and health­care to re­li­gious in­sti­tu­tions.  We need lead­er­ship from busi­ness.  We need lead­er­ship from law­yers, we need lead­er­ship from all angles for us to achieve what we are try­ing to achieve.“A part­ner­ship with an in­sti­tu­tion like CMS can only help us to move for­ward and can only make us have sus­tain­able de­vel­op­ment on our agenda and we will need your help to en­sure that we are sup­port­ing coun­tries come up with very strong laws.”Dr Ro­land Wir­ing, a life sci­ences part­ner and Head of In­tel­lec­tu­al Prop­erty at CMS Ham­burg, com­men­ted: “Gov­ernance, so­cial re­spons­ib­il­ity and en­vir­on­ment­al pro­tec­tion risk is of course at the core of the ESG is­sues that pharma com­pan­ies and tech com­pan­ies face.  What the UN does in this con­text, is im­press­ive, and can also in­spire, from our point of view both our work and the work of the cli­ents of the in­dustry.”

From A&G and half board to opaque book­ings and VR – the Hotel In­dustry Jar­gon Buster provides you with a com­pre­hens­ive list of the most cur­rent terms in the hotel in­dustry.This easy-to-use format al­lows...

The COV­ID-19 pan­dem­ic led many ten­ants to re-ne­go­ti­ate their lease agree­ments, oth­ers in turn have stopped pay­ing rent or paid a re­duced amount.After over a year of the pan­dem­ic bring­ing vari­ous busi­ness...

Glob­al­isa­tion, polit­ic­al tur­bu­lence, changes in urb­an liv­ing pat­terns, in­creased di­git­isa­tion, shift­ing con­sumer be­ha­viour and flex­ible work­ing are just some of the is­sues that are trans­form­ing the de­mands...

We are very pleased to share with you the first edi­tion of the CMS European Private Equity Study 2022.This study ana­lyses over 100 CMS Private Equity deals that we ad­vised on in 2021 also tak­ing in­to ac­count for com­par­is­on data of PE deals we ad­vised on in 2020 and trade deals of both peri­ods. Key find­ings based on ana­lys­is of 2021 deals Deal activ­ity: deal volume was in line with gen­er­al mar­ket trends, with a sig­ni­fic­ant de­crease in deal activ­ity in 2020, the year of the out­break of COV­ID-19, fol­lowed by an un­pre­ced­en­ted level of activ­ity in 2021.Deal Drivers: one of 2021's ma­jor deal drivers was di­git­al­isa­tion (11% in 2021 com­pared to 2% in 2019 and 2020).For­eign In­vest­ment Con­trol: In 2021, 14.8% of the PE deals we ana­lysed in­cluded some form of FDI ap­prov­al pro­cess as part of the con­trac­tu­al terms.W&I In­sur­ance: The num­ber of PE deals fea­tur­ing W&I in­sur­ance in­creased from 36% in 2020 to 42% in 2021. In high­er value deals (where the pur­chase price is more than EUR 100m), W&I in­sur­ance cov­er­age is now the stand­ard, hav­ing been used in 74% of the PE deals we ana­lysed.Man­age­ment in­cent­ive schemes: The ma­jor­ity of the in­cent­ive schemes re­viewed al­loc­ated up to 25% of the exit pro­ceeds to man­age­ment. In more than 70% of cases leav­er pro­vi­sions ap­ply and, when triggered, man­age­ment has to for­feit or sell (de­pend­ing on wheth­er they are a good or bad leav­er) both sweet equity and any strip (e.g. rollover in­vest­ment).