A safe space — looking at protective measures in pharma
After recent events, it seems that more than ever protective measures are made to ensure pharma is a safe space for companies and patients.
As we begin the process of healing after the devastating terror attack on vulnerable people in Manchester and the shock of the recent cyber-attack affecting vast amounts of systems across Europe subsides, the questions arise of how do we manage these disturbing and disruptive problems and what preventative measures should be taken for future protection?
One of the key challenges that has faced the pharmaceutical industry is that of counterfeit medicines. Back in 2006 charges were brought against 19 people for illegal racketeering in support of terrorist operations by the US Attorney’s Office.1 In this case, it was alleged that portions of the profits made from the sale of counterfeit products was used to fund foreign terrorist organisation Hizballah. However, we must also consider the possibility that within counterfeiting there is also an opportunity to infiltrate the product with other chemicals to cause damage to other human beings.
To fight counterfeiting, we have seen the introduction of regulatory legislation, such as the EU Falsified Medicines Directive (FMD). This will provide tougher rules about the packaging of medicines, inspections and controls of API producers and will require strengthened record-keeping for distributors. Through these measures, public health protection will be improved.
With these tougher measures, however, comes the issue of how IT will manage the vast amount of data that needs to be compiled in order for companies to ensure full compliance with the directive. Here in lies another potential risk for the pharma industry. As we recently saw, ransomware can cause mass disruption across multiple sites with little or no warning. Speaking to Microsoft, the BBC reported that the recent cyber-attacks “should be treated by governments around the world as a ‘wake-up call’.”2
There are already certain standards in place, such as the global SAFE-BioPharma initiative, created by the biopharmaceutical industry and its regulators. This helps to protect cyber-transactions in biopharmaceuticals and healthcare through the use of identity credentials.3
However, we must not close doors and borders through fear of attack. A globalisation of science is necessary in the fight against global health threats as was stressed by Dr Carmen Peña, president of the International Pharmaceutical Federation (FIP) during the 6th Pharmaceutical Sciences World Congress.
“The bringing together of different fields of expertise, sectors and nationalities will help solve health issues. Integration will become the key word in the success of the pharmaceutical sciences,” she said. “Integration also means that borders between clinical trials and post-marketing surveillance are shifting to allow faster access to innovations while limiting risks for patients.”
So, what does the future look like? With track and trace already hot on the agenda, we should be able to rest assured that pharma is doing all in its power to make the industry as safe as possible. By 2019 most countries will have regulations in place in some form or another that will offer an extra line of security. Extra security online, such as the SAFE BioPharma initiative, will help to prevent serious issues in the face of ransomware attacks, but vigilance with IT is always recommended.
In essence, it is imperative that we do not fold to these acts of terrorism, while being vigilant and ensuring preparations are made to keep patients and companies as safe as possible from threat, it is also vital to continue to work globally in combatting health issues.
Thanks,
Felicity
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