It is perhaps inevitable that an industry like biotechnology, which is closely involved with people’s wellbeing, indeed with their life and death, should be subject to particular scrutiny with regard to its legal and ethical standards. The biotechnology industry, more than most, needs to be able to demonstrate its adherence to good practice. Compliance must, therefore, be a major priority for firms in the field of biotechnology. Good-quality training, at every level, is of vital importance; and in a constantly changing field, few organisations are likely to have the resources in-house. Successful companies seek compliance training support from experts in the field such as Interactive Services.
Here we list nine challenges that need to be addressed if your training is to be effective in ensuring compliance. Some refer to developing regulation and legislation; others to issues within the organisation itself, which will impact on its ability to respond to external forces.
1. Identification of Medicinal Products (IDMP)
Staying up-to-date is a major priority for compliance officers. An example of new legislation with far-reaching consequences for companies doing business internationally is the introduction of Identification of Medicinal Products (IDMP) Data Standards, currently being developed by the International Organisation for Standardisation (ISO) and other interested parties. This legislation is global in its effects; although the EU is the first region to adopt IDMP, the US, Japan and the rest of the world are following the same route.
The EU has delayed its timetable for the implementation of IDMP until after 2020, but preparations are starting now. This suite of five standards will provide an internationally-accepted framework to uniquely identify and describe medicinal products with consistent documentation, coding and exchange of product information between global regulators, manufacturers, suppliers and distributors.
Pharmaceutical companies will be required under these standards to submit detailed product data electronically and maintain the product database. Because this legislation affects organisations at every level, from Research and Development to sales and administration, training from a reputable provider is essential.
2. Price Transparency
The Trump administration’s ‘American Patients First’ policy followed California’s decision to bring in new drug price transparency laws. Already, numerous drug makers have had to cancel planned price increases, and it seems likely that more state and federal legislation will follow. Massachusetts has considered taking an entirely different approach to price controls, by asking the administration for permission to allow the state’s Medicaid program to refuse to pay for some drugs, citing rising costs of care and increases in the percentage of residents covered under commercial insurance.
Price transparency is set to be a major compliance issue in years to come; the National Academy for State Health Policy (NASHP) is working to help states increase transparency by supporting the alignment of data collection and enabling cross-state analyses. Biotechnology companies will need to look carefully at their pricing models if they are not to encounter problems with this issue, and will need to engage a reputable training provider with the latest knowledge of local legislation.
3. Big Data and Data Mining
Perhaps the most promising area of current research and development in biotechnology is the use of Big Data – the manipulation and analysis of huge data sets. The difference between “mining” and research is that “mining” means discovering something which already exists; data mining is the process of identifying hidden patterns, relationships, and trends within data. It can assist in everything from the design of improved clinical trials to the analysis of side effects using social media.
But there are clear implications for privacy, and the regulations applying to data mining are evolving rapidly. The issue is complicated by the fact that many data sets are international in scope, whereas the rules are made and applied locally – an obvious minefield for compliance, requiring a compliance training provider with tools which can respond quickly to legislative change; e-learning is a particularly appropriate medium.
4. Compliance with current good manufacturing practices (cGMPs)
In the US, cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. These standards govern the identity, strength, quality, and purity of drug products. Adhering to cGMPs can only be achieved by rigorous control of manufacturing operations. The importance of maintaining reliable testing laboratories cannot be overstated in avoiding the risk of potentially life-threatening errors such as contamination and mis-labelling.
The US Department of Justice has pursued pharmaceutical companies for non-compliance with current good manufacturing practices on a number of occasions in recent years. Drug companies potentially face criminal and civil penalties amounting to many millions of dollars.
The effects of this regulation are not confined to companies operating within the US. In 2015, the FDA wrote a strongly-worded warning letter to Canadian company drugs Apotex (which manufactures in India) saying it had lapses in its data control, written procedures, and information systems. The letter concluded:
Because you failed to correct repeat violations, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance, and evaluate the completion and effectiveness of any corrective actions and preventive actions you have implemented before you pursue resolution of your firm’s compliance status with FDA. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.
The implications for pharma companies could not be clearer. Expert compliance training is essential, which takes into account the tans-national nature of the biotechnology industry and can handle companies with multiple locations. Integrity Ethics and Compliance Training is available in over 30 languages.
5. Bribery and Fraud
As concern mounts about the opioid crisis, it seems likely that the criminal law will increasingly be applied to cases of misprescribing. In January 2019, a pharmaceutical executive, John Kapoor, who marketed the drug Fentanyl, was sent for trial in Boston MA on charges relating to racketeering, mail fraud and wire fraud conspiracy. The prosecutors claimed that John Kapoor had turned to “bribes and fraud” to try to sell Fentanyl (a drug specifically aimed at cancer sufferers) for use by patients without cancer.
He had bribed doctors to prescribe patients an addictive Fentanyl spray that was much more powerful than morphine. The Assistant U.S. Attorney told the court “This is a case about greed and the consequences of putting profits over people.” Kapoor was found guilty after fifteen days of jury deliberation, and he faces up to twenty years in prison. Other lawsuits are underway; in May 2019, Oklahoma will be the first state to go to trial, suing Purdue Pharma, the manufacturer of Oxycontin, the most well-known prescription opioid, and several other companies, claiming they hid the addictive nature of their products.
The Oklahoma Attorney General said the trial would
“allow individuals to see how these companies maliciously deceived the nation while creating the deadliest manmade epidemic in United States history”.
The penalties imposed, if and when prosecutions like these succeed, are likely to be huge, far outweighing the costs of providing the essential anti-bribery and anti-corruption training which could have prevented the offence.
6. False Claims Act (FCA)
The FCA came into the news in April 2019 when two US pharmaceutical companies, Astellas Pharma US and Amgen, were ordered to pay a total of $124.75 million to resolve allegations by the U.S. Attorney that they violated the False Claims Act by conspiring
“..with two co-pay foundations to create funds that functioned almost exclusively to benefit patients taking Astellas and Amgen drugs.
As a result, the companies’ payments to the foundations were not ‘donations,’ but rather were kickbacks.” Clearly, a fine line was breached with major financial and reputational costs for the companies involved.
Another industry practice which has fallen foul of the FCA is so-called “white coat marketing”; the practice of physicians, nurses, and other professionals advertising or marketing pharmaceutical products. Because patients may have difficulty distinguishing between professional medical advice and a commercial sales pitch, this practice places a particular duty on the purveyor to be objective and accurate – another fine line which may be crossed without adequate training by an expert provider such as Interactive Services.
7. Ethics in Clinical Trials
Ethical issues with regard to clinical trials are a matter for continuing debate. Concern has increased over recent years partly as a result of well-publicised cases such as that of Jesse Gelsinger, who died in a gene therapy trial at the University of Pennsylvania. The institution was widely criticized for failing to disclose crucial information on informed consent documents, relaxing criteria for accepting volunteers and enrolling volunteers who were ineligible.
This was the first death directly attributed to gene therapy, and it resulted in the Federal Drug Administration (FDA) suspending all GT trials. In the United States, there are multiple agencies (granting bodies, IRBs, and data and safety monitoring boards) now seeking to ensure that a trial follows sound ethical practices.
But increased legislation has led to new concerns that research is being unduly restricted; the EU Clinical Trials Regulation, enacted in 2016, was intended to restore the EU’s competitiveness in clinical research, and enable the development of new and innovative treatments and medicines by reducing regulation, thus bringing patient-oriented research back to Europe. Ethics in Medical Research is a large and complex subject requiring rigorous training from high-quality training providers such as Interactive Services.
8. Corporate Culture
Price Waterhouse Cooper’s report ‘From Vision to Decision Pharma 2020’ suggests that the biotechnology industry faces three fundamental challenges; rising customer expectations, low scientific productivity, and what it terms ‘cultural sclerosis’. PWC asserts that the industry’s management culture, mental models, and business strategies remain unchanged whilst other more innovative fields, such as electronics, have moved on.
Successful pharmaceutical companies have a corporate culture which encourages innovation, and in which the Sales and Marketing sector works with and for the Research and Development sector rather than in conflict with it. Although creating a culture of trust and innovation is not easy, there are established ways of achieving this goal, and the right kind of training can be effective in helping companies move forward.
In the past, leadership within the biotechnology industry often relied on the “hero” model – the idea that everything depended on the charismatic individual (generally male) at the head. But in successful companies, leadership is the responsibility of everyone within the team; a non-hierarchical approach which devolves leadership to individuals at all levels. Developing leadership behaviours is an important element of training within an industry in which failure and success both pose challenges. Contrary to popular belief, leadership is not necessarily innate but is a skill which can be taught and developed with the right training programme.
These nine challenges are not the only ones facing the biotechnology industry. Effective compliance training is crucial to both the management of risk and the maintenance of a successful business model. Need assistance with your Compliance Training? Talk to us today.