by Helen Collis
LONDON, Nov 25 (APM) - Industry needs a “master framework” to understand how and when to incorporate patients’ views into the development of medicines, a conference heard.
Speaking at the EMA/TOPRA meeting in London on Thursday, Lode Dewulf, chief patient affairs officer and vice-president at UCB Belgium, said there are many isolated examples of successful patient involvement currently, but no clear global guideline for industry and regulators to follow.
“What we really need is a master framework. But the good news is that we don’t need to start from scratch,” he said.
Around the world there were “many initiatives”, he said, “but the biggest problem is that they are isolated from each other”.
A global framework would ensure “best practice and consistency of coordination” between industry, patients and regulators, he added.
The conference heard last week that carefully-selected patient representatives were already involved in most drug committee meetings at the European Medicines Agency, including at the pharmacovigilance committee PRAC, orphan drugs committee and paediatric therapies committee.(APMMA 40524)
The EMA has also launched a pilot to include at least two patient representatives in its broader scientific committee, the CHMP, which assesses the benefit-risk profile of most new drugs.
Lode said among the first issues in designing a framework was defining what is meant by the ‘patient’. He highlighted that currently, there is no common definition of what a patient is.
He said patients' biggest concerns are related to the impact their disease has on their family, and so suggested a definition that incorporates all those affected by a disease.
Emphasising a real need to raise awareness in industry of the need to involve patients in the development process, he said: “30-50% of companies are not even planning to engage with patients - that’s a big portion. We need to raise awareness.”
Not only should patient engagement begin early in the drug’s clinical development, but it should continue throughout its life cycle, Lode said.
Of particular concern was the usefulness of drug leaflets and labelling, an area he said would benefit from greater engagement with the patient community.
“Labels seem to get heavier over the years when the data should be more clear,” he said.
Lode said one of the main challenges in understanding how best to engage with patients, was that there was very little evidence-based data out there.
He urged companies that are testing the water with patient involvement to share their experiences, for the greater good.
“Let’s move away from competition and share our knowledge about patients. It’s what we do with that knowledge - that is where it becomes competitive. A patient organisation doesn't work on exclusivity.”
Such an approach would further contribute to building a trusted and respected industry with both patients and regulators, he added.
He also urged that the joint EU-U.S.-Japan regulatory body ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) addresses the need for a standardised protocol for patient engagement “as quickly as possible”.
“Set the priorities and at last establish the minimum best practice which we can share,” he urged representatives of all three regulators present at the meeting.
He said UCB has developed its own compliance framework which is scheduled to be published in a forthcoming journal, “as we believe it’s important to everybody”.
hlc\nh
TRY APM Market Access AND GET ACCESS TO THE FULL CONTENT
Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations
Events coverage with a unique focus on Market Access & sustainability of healthcare systems
6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris
Ask for a Free trial and get access to the latest stories
Our coverage includes:
- Health Care
- Market Access
- HTA – policies & practices
- European medicine regulations
- Drug safety issues
- Pricing & Reimbursement
- International medicines agencies
If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.
REQUEST
an initial 10 day temporary access of APM Market Access.
