“We Have an LQPPV” Isn’t the Same as “We Have a Local PV System”

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The Trap of “We Have an LQPPV”

We have appointed an LQPPV. We have a local PV system.

This is a trap many multinational Marketing Authorisation Holders (MAHs) fall into when trying to comply with PV regulations in Africa. The problem stems from a mindset that treats the appointment of a Local Qualified Person for Pharmacovigilance (LQPPV) as a compliance check box rather than as the appointment of someone who is truly empowered to promote and maintain patient and drug safety in a country. An LQPPV is an important part of the local PV system, but not the entire system itself.

What GVP Inspections are Revealing

In recent months, I have observed several recurring findings from Good Vigilance Practice (GVP) inspections in Africa that highlight weaknesses in local PV systems across different countries, even where MAHs have appointed LQPPVs. 

Some of the findings include:

• Low-volumes of Individual Case Safety Reports (ICSRs) submitted to health authorities
• Lack of basic PV training for sales representatives
• Disconnect between the LQPPVs and key stakeholders, including sales representatives and drug distributors
• Lack of clear reporting channels for the public to communicate safety concerns to MAHs

Taken together, these findings stress that the presence of an LQPPV alone does not guarantee a functional local PV system.

What an Effective Local PV System Should Look Like

An effective local PV system should be capable of identifying, collecting, assessing and communicating safety issues to healthcare professionals and patients. When an MAH discloses that it has received no safety reports over a period of two years, it points to a system that is not functional. Likewise, when a sales representative interviewed during a GVP inspection does not know who the LQPPV is, it signals a disconnect between the PV function and the wider organisation.

So how can MAHs build and strengthen local PV systems that work effectively in Africa? I will share practical steps based on my own experience as an LQPPV and the work I am doing together with the MAHs to strengthen our local PV system.

Practical Steps I Am Taking as an LQPPV

• Understanding the PV responsibilities of all stakeholders

I have access to Pharmacovigilance Agreements (PVAs) between the MAH and its distributors. This has helped me understand the PV obligations of each party, and identify clear points of contact at the distributors.

• Participating in distributor PV audits

I sit in when the MAH conducts distributor PV audits. This has provided deeper insight into distributor PV structures and helped identify whatever obligations in the PVAs the MAH may not be fully implementing.

• Supporting distributor risk assessments

I am also involved in the risk assessment of distributor PV systems to gauge their level of maturity and help determine who to audit and at what frequency.

• Strengthening PV training beyond compliance expectations

Most PVAs state that each party is responsible for training its own staff. My recent experience has shown that distributor teams often do not receive adequate PV training. The gaps frequently become visible only when an inspection is conducted. To address this, as an LQPPV, I have taken the initiative to provide annual PV training to distributors.

• Building continuous engagement with sales teams

Rather than interacting with the distributors only during training sessions, I also hold quarterly meetings with the sales teams. These discussions address any product safety-related concerns and encourage sales persons to be PV ambassadors when engaging with healthcare professionals (HCPs).

• Using commercial insights to target PV activities

Engagement with sales teams also helps identify which products are commercially active and target PV activities to those products. Product lists maintained by PV teams often show products registered in a country, but not necessarily which ones are being marketed and sold.

• Improving accessibility of reporting channels

Most MAHs provide information on their websites about how to report suspected adverse effects of their medicines. However, these resources are often country-specific contacts tailored to the ‘larger markets’ while African countries are thrown under  ‘the rest of the world’ without any dedicated local contacts. We are working to make contact information of the LQPPV available on this site so that patients and HCPs know exactly where to report safety issues.

Compliance Is Not the End Goal — Patient Safety Is

The hope is that these steps can eventually increase the volume of ICSRs received by MAHs from Africa and improve the safe use of medicines on the continent. That is the ultimate goal of pharmacovigilance. I recognise that MAHs may view these practical steps primarily through a compliance lens – reducing negative inspection findings and improving regulatory outcomes. The actions would certainly support compliance yet achieving a high compliance score shouldn’t be the end goal. The goal should always be medicine and patient safety. Inspections have limitations because they’re based on sampling. They cannot identify every weakness within a PV system. No MAH has a perfect PV system. What matters is the willingness to recognise and acknowledge gaps, address them and continuously improve. The GVP inspection findings mentioned above do not come as a surprise to most MAHs but there continues to be a reluctance to proactively address them, and a reliance on inspections to highlight them.

The Path Forward for MAHs in Africa

PV is a collective effort involving several stakeholders. However, the reality is that many MAHs with products in Africa have not invested enough in strengthening their local PV systems, partly because of historically weak regulatory environments. That is gradually changing. Heightened GVP inspections across Africa are forcing MAHs to rethink their PV strategies and double down on their PV activities. Effective pharmacovigilance will depend on closer collaboration between the MAHs and their LQPPVs, distributors, sales representatives, healthcare professionals, patients and regulatory authorities.

Written by

Odokonyero Kennedy

Pharmacist, Global Shaper at Kampala Hub and student of Msc. Pharmaceuticals and Health Supplies Management at Makerere University. [email protected]

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