< PreviousETHICS20Pharma Business International www.pbiforum.net© Shutterstock /NumstockerCuring theindustry Curing theindustry Pharma Business International 21www.pbiforum.netETHICSIn mid-July, government inspectors in China found thatChangchun Changsheng Biotechnology, the nation’s secondlargest manufacturer of rabies vaccines, had forged reports,violated regulations and knowingly supplied 250,000 faultyrabies vaccines. Hundreds of thousands of Chinese childrencould have been injected with these defective medicines. Days after this discovery, the China Food and DrugAdministration suspended the production of the vaccine andpromptly recalled the product from disease-preventionorganisations. Efforts were made to try and keep a lid on thepowder keg by censoring media posts, but the story soon wentviral on social media and was picked up my media outletsacross the country. In now deleted posts on Chinese social network WeChat, ananonymous whistle-blower laid bare the shadowy depth andseverity of the scandal. It alleged that the corruption withinChangchun and, by extension, the Chinese pharmaceuticalindustry, stretched back decades, with similar cases involvingvaccines for hepatitis b and chicken pox. The post also allegedto an intricate web of scandal and corruption involvingshareholders, excessive profits and even mistresses. Much ofthis is unsubstantiated, with the rest vehemently denied, anddespite pains to get the post taken down, the damage wasalready done. Pandora’s box was open. News providers were quick to leap-frog onto the story and,right across the country, people were losing their faith in thegovernment and their healthcare providers. Media outletsreferred to the crisis as the worst public health scandal in years,while President Xi Jinping, who rarely comments on pubiccases, described it as “appalling” and “vile and shocking”. This latest scandal was symptomatic of a deeper, moreingrained issue within the Chinese pharmaceutical industry,where scandals and regulatory offenses are neither rare nornew. Back in November, Changchun was forced to recall morethan 250,000 ineffective does of vaccines for DPT (diphtheria,pertussis and tetanus). In 2016, a hospital pharmacist wasfound to have sold two million doses of vaccines stored inunsuitable and unhygienic conditions. The year before,hundreds of children in Henan province were reported to havefallen ill after being given out-of-date vaccines. Earlier still, in2010, Chinese media outlets reported that unrefrigeratedvaccines had resulted in the deaths of four children. These scandals all echo the major 2008 case where tainted22 ÁThe latest scandal to rock the Chinese pharmaceuticalindustry has ruptured public faith in government andsparked a global discussion on ethics in the supplychain. ETHICS22Pharma Business International www.pbiforum.netmilk powder killed six infants and left a further 300,000 ill.It’s no exaggeration to say that the Chinese public’s faithin the government’s ability to keep them safe is atbreaking point. As with the tainted milk powder scandal before it, thislatest regulatory controversy differs from others that haveblighted the supply chain because of the sheer level ofchildren is has possibly affected. To give some context,rabies is still a major issue in China. According to theWorld Health Organisation, the virus was endemicthroughout most of China until the nineties. Even today,the country still claims the highest number of reportedrabies cases anywhere in the world. Unsurprisingly, thegovernment has been working to scale-up the country’simmunisation programme. This means that most childrenhave received a vaccine similar to those made byChangchun, with hundreds of thousands believed to havereceived the faulty vaccine. As of publishing, however,none of these defective vaccines have been linked to anydeaths or illnesses but have served to provide a fresh faceto the ethical quagmire that is often the Chinesepharmaceutical industry. The nation’s top graft investigation agency has statedthat it will thoroughly investigate the scandal, while policein the north-eastern city of Changchun, where thedisgraced company is based, revealed on social mediathat they had opened a criminal investigation into theillegal production of rabies vaccine. To date, fifteenpeople, including the company’s own chairwoman, havebeen arrested on suspicion of criminal offences.Meanwhile, Li Keqiang, Premier of the People’s Republicof China, said that this latest case had crossed a “line ofhuman ethics” and vowed there would be harshconsequences for any infractions or lax supervision. The Changchun Changsheng Biotechnology scandal isthe latest in a long and troubling line of crises to rockChina’s pharmaceutical industry at a time when thecountry is trying to position itself as a pharmaceuticalpowerhouse to compete with the United States andBritain. That goal is nigh impossible without the faith ofthe public on side and at a time where public faith in thegovernment’s ability to keep them safe is arguable at itslowest, the country has a difficult time ahead. © Shutterstock /DrnookerREGULATION24Pharma Business International www.pbiforum.netRegulation exists to ensure that companies operating within the pharmaceuticalsupply chain comply with the specific rules and laws pertinent to that industry.What begins in drug development is equally as important when it comes tomanufacturing and clinical trials (which you can read more about on page 28).Regulation also acts as a guiding light in securing marketing authorisation andcontinues right through to labelling, advertising and the overall monitoring of safety.Think of it like the connective tissue, binding all the disparate moving parts of thiscomplex and multi-faceted industry together. Brexit has been cause for concern for many sectors, no least medicine andpharma. One of the biggest concerns is how the UK’s regulatory framework willcontinue to function in a post-Brexit environment. To allay some of these fears, theMedicines and Healthcare Regulatory Agency has vehemently stated that there will26 ÁRegulating apost-Brexit BritainThe repercussions of Brexit and the absence of the EuropeanMedicines Agency means Britain’s pharmaceutical regulationmight get more complicated. Regulating apost-Brexit BritainPharma Business International 25www.pbiforum.netREGULATION© Shutterstock /Angel Soler Gollonetbe no sudden change to this framework when it leaves theEuropean Union in March 2019. Reading between the linesand it seems as though changes will instead be gradual,but there will indeed be changes. In a statement, the Agency said: “On 4 July 2018 the UKGovernment gave a clear, public statement of its desire toretain a close working partnership in respect of medicinesregulation after the UK leaves the EU, in the interests ofpublic health and safety. The statement, published in theFinancial Times, by the Secretary of State for Health andSecretary of State for Business, Energy and IndustrialStrategy laid out the three principles which will underpin thedevelopment of a post-Brexit regulatory system formedicines and devices: patients should not bedisadvantaged; innovators should be able to access the UKmarket as quickly and simply as possible; and we willcontinue to play a leading role in both Europe and theworld in promoting public health.”They were sentiments echoed across the UK’s pharmasector, with the Association of the British Pharma Industry(ABPI) rallying behind this. In its own statement, theorganisation said: “We share the MHRA and theGovernment’s ambition for patients in the UK and EU tohave continued access to best and most innovativemedicines through a close working relationship withEurope, underpinned by the strongest regulatory frameworkand the sharing of data. This is an outcome we shallcontinue to work towards – yet, if such cooperation isunable to be agreed we welcome the MHRA’s intent to takea pragmatic approach. Planning for this scenario does,however, require further detail, and further highlights why arealistic implementation period needs to be urgentlyagreed.”Despite all this, there has already been an upending ofthe status quo, with the European Medicine Agency (EMA)leaving its current London base for Amsterdam. This was indirect response to Britain’s decision to leave the EU. Thismeans that quality control checks of medicine carried out inthe UK will no longer satisfy EU requirements. To furtherconfound the nation’s competitiveness in the pharmasector, both GlaxoSmithKline and AstraZeneca havealready set up new testing labs in mainland Europe, thebetter to comply with the EMA. The future of regulation in a post-Brexit Britain is stillunclear, though the rhetoric from industry and governmentoffers some insight into the overall attitudes. Clearly,preserving the nation’s competitiveness is key, but withglobal pharma companies favouring mainland Europe overBritain now, and with the EMA relocating altogether, it willbe a challenging time ahead.REGULATION26Pharma Business International www.pbiforum.net© Shutterstock /Alessandro ZappalortoPharma Business International 27www.pbiforum.netONCOLOGY© Shutterstock /cbiesREGULATIONCLINICAL TRIALSClinical trials can court controversy,attracting unwarranted media attention andcausing a pharmaceutical company’s sharesto plummet. During work on this very issue ofPharma Business International, news broke ofa Dutch clinical trial being stopped after thedeaths of eleven babies. The test saw 183women taking sildenafil – a generic version ofPfizer’s Viagra – during pregnancy. The aimwas to see if the drug increased the growth oftheir children as they all had undevelopedplacentas. However, more mothers than hadbeen expected by the research team wereborn with lung problems, leading to multiplefatalities. Though patient deaths are part of the riskinvolved in clinical trials, it’s the way in whichtrials are handled that many have takenumbrage with. The majority of clinical trialsfail, with their results never finding their wayinto peer-review journals or in the public arenawhere they can be picked apart andscrutinised. It has led to calls for changing theway in which trials are organised and,crucially, how they are reported on,irrespective of their outcome. However, instigating this far-reaching seachange isn’t only difficult to introducte, butharder still to maintain. Trials are beholden topatients or the public to generate results fromwhich new medicines live and die. The troubleis, it’s participants themselves that can leaveresearchers with a headache. Clinical trials are a multi-phase process. Inmost cases, a new drug or treatment will firstbe tested on a small number of volunteers,with any results being monitored and pouredover before it is then tested on hundreds –perhaps even thousands – of volunteers. Thebigger the pool of volunteers, however, thelikelier the chance that some of them will dropout. It’s an issue that researchers must dealwith during any trial and is of particularaggravation during cases where results needto be monitored over time. The average dropout rate of clinical trialsGettingbetter results The launch of a new pharmaceutical or medical product is a long road paved withexhaustive, often strenuous research and development. As one of the key stages,clinical trials are a proving ground where new therapies, treatments andmedicines can be validated or discovered to be a dud. In any outcome, theyprovide researchers, clinicians and scientists with valuable insight that will shapefuture research endeavours and the fate of new product launches. 30 Á28Pharma Business International www.pbiforum.net© Shutterstock /Kaspars GrinvaldsNext >