The pharmaceutical industry is among the most heavily regulated in the world. While its complex set of cascading regulations exist to protect both patients and medical professionals alike, they can be very difficult to navigate without the correct expertise and experience. Pharmaceutical compliance can, quite literally, be a matter of life and death. It goes without saying that full compliance is table-stakes for all organisations operating in this sector. Clearly, non-compliance poses considerable risk for pharmaceutical companies, everything from fines to loss of business licenses, in some territories, final approvers could attract prison sentences.
Yet, compliance remains a challenge for many pharmaceutical companies as compliance regulations continue to evolve in the post-COVID world. Moreover, as technological advancements underpin the creation of new treatments at a greater pace than ever before, the goalposts are always moving – making it challenging to reach and maintain the regulatory requirements and, ultimately, avoid potentially damaging penalties.
Compliance requirements are for all pharmaceutical companies, and all must adhere to them. However, it is particularly challenging for small to medium size companies to create, manage and maintain full compliance.
Below are three of the most pressing challenges pharmaceutical organisations face along their compliance journeys.
Anti-Corruption
In September 2015 an agenda called Sustainable Development Goals, now adapted into the 2030 Agenda for Sustainable Development was launched. Under this agenda, all governments are required to fight for comprehensive global development and in the health sector, this means, among other issues, the integration of good governance into policy-making in order to combat corruption. A number of global examples were highlighted to demonstrate how corruption in the pharmaceutical industry endangers positive outcomes in the health sector and increases the rate of non-compliance within the industry. In order to implement effective anti-corruption measures, policymakers must first identify the pharmaceutical industry’s corruption vulnerabilities, and adapt accordingly. These vulnerabilities include but are not limited to:
- A lack of objective data and understanding of corruption
- A scarcity of legislative and regulatory support
- An absence of leadership commitment toward anti-corruption efforts.
These indiscretions can result in non-compliant penalties as well as serious risk to the health of patients.
Pricing & Quality
Almost all organisations in the pharmaceutical industry have ambitions to expand internationally. However, the challenge lies in finding an efficient way to do so. To be ‘authorised for sale’ in a specific geography, pharmaceutical companies must follow the rules laid out by that country’s regulatory agencies. In this respect, it is imperative that a systematic method of tracking and controlling products is established, along with maintaining traceability for each unique market.
With complex global supply chains, pharmaceutical companies seek out competitive advantage in regions such as Asia, not only for lower labour costs but because of the growing demand for medications in countries like China and India. Companies implementing a quality system must often adjust their approach according to their location. Regulatory authorities seeking to harmonize standards also face challenges due to regional differences in risk perception.
Manufacturers in emerging markets occasionally make two types of drugs to satisfy two different markets. In the external market for people outside of the country, there must be full compliance with international regulations; and in the internal market, lower-quality products might be compromised if they are lower in price. This puts drug makers, regulators, and governments in a difficult situation, and this often has a huge effect on an organisation’s compliance with required regulations.
Auditing
Life sciences companies should be always audit-ready, but this is easier said than done. Due to the differences between regulatory authorities and how frequently they change, pharmaceutical companies often have difficulty figuring out regulatory requirements. It is fair to say that there is a degree of interpretation within some of the country requirements as they can be seen as being not specific but more ‘grey’ and thus the challenge is maintaining compliance when some areas of the requirements are vague. This is why compliance in the healthcare industry demands companies figure out what those requirements mean and what is applicable to them. It is, unfortunately, difficult to have a single strategy that would apply to all companies because there are a variety of different issues and considerations that need to be kept in mind when it comes to deciding an approach.
In order to accurately follow regulatory standards, an organisation needs to first understand the exact purpose of regulatory strategy. Setting up an experienced regulatory affairs team should be a company’s top priority. Working with regulatory affairs representatives is easier for companies that understand regulatory compliance.
It goes without saying that pharmaceutical compliance in the post-COVID world is more complex than ever before. Organisations today face severe fines and even prison sentences if they approach compliance in the wrong way. At SCM, we understand how to deliver an innovative approach to compliance. Our boots-on-the-ground experience enables us to understand the specific compliance challenges faced by pharmaceutical organisations today. If you have compliance needs or wish to find out the current status of your compliance regime a simple ‘health-check might be the first step, please feel free to reach out to us below.