IP Boosts Innovation In Malaysian Cervical Cancer Screening

Malaysia’s ROSE system makes it easy for women to get screened for cervical cancer. Like all digital health systems, it could not function without IP.

KUALA LUMPUR, July 8 — Cervical cancer is the third most common cancer in women in Malaysia,[1]but its screening rate is unacceptably low.

Only 12.9 percent of women in Malaysia have a pap smear once in their life, usually after giving birth. The World Health Organisation’s (WHO) target is 70 percent HPV screening coverage for women aged 35 to 45, and the test is recommended every three years.

On the rare occasion that a Malaysian woman has a pap exam at a government clinic, she has to wait three months for the facility to call her, and then only if results are abnormal. Without a call, they presume the results are normal.

To boost screening rates, Universiti Malaya consultant obstetrician and gynaecologist Prof Dr Woo Yin Ling teamed up with experts from the non-profit VCS Foundation in Australia to develop ROSE (Removing Obstacles to Cervical Screening), a system that can track women and reminds them to take a HPV cervical screening test at the age of 35.

“We bring the test to the woman. They can come and get it done.”

Dr Woo hopes ROSE will help all women in Malaysia aged between 30 and 65 take the HPV test three times in their lifetime.

“Screening is like a whole obstacle race,” says Dr Woo. “The test is just one obstacle. We really need to move towards any screening intervention as a course of obstacles, at which every obstacle you need to deal with, from getting the women to go to the obstacle in the first place. If we are very good at doing the test, but we’re not good at doing follow-up, which is the next obstacle, we don’t finish the race at all,” she added.

The ROSE system is easier for women and reduces the overload on government clinics. Its less intrusive self-sampling method (compared to a pap smear conducted by a health care professional), sends women the test results directly, follows up if the results are abnormal, and ensures they take the test twice more in their life after registering them in a database.

How ROSE Works

ROSE integrates the patient more closely into the screening infrastructure. It empowers women to take charge of their own cervical screening using a novel method of self-testing and a digital health platform.

A woman registers for ROSE on her mobile at the government clinic and gets instructions on how to self-test.

The HPV test simply requires women to insert a swab into their vagina. After the sample is submitted to their registered healthcare facility, it is tested and the woman receives the results via an SMS within three days.

The self-administered test is more effective and sensitive in detecting HPV.

“Instead of having a horrible pap smear test, what a woman needs to do is to put this (brush tip swab) into the vagina. It is smaller than a tampon and women can do it themselves,” Dr Woo says.

By receiving results on their mobile phones, women avoid a potentially time-consuming and stressful experience using the traditional health system.

Self-sampling also cuts down the need for equipment and manpower to carry out a test, Dr Woo says.

“We don’t need a room, we don’t need a bed, and we don’t need staff. The women register and take the sample themselves behind a curtain,” says Dr Woo. “So the solution is very simple and can be incorporated in the clinics immediately.

“The whole idea with this programme is there is nothing to stop me getting a mobile clinic and parking it at a low-cost housing flat or going to interior areas of the country.

“We bring the test to the woman. They can come and get it done.”

The ROSE system will initially target patients at government clinics. It will ensure women don’t take the HPV test every year unnecessarily by logging their IC number in a registry compliant with the Personal Data Protection Act (PDPA). They only need to take it every five years where resources permit, while WHO suggests two tests a lifetime is sufficient.

In a 2017 pilot at government clinics, 50 to 60 patients completed the ROSE process daily. By contrast, just five pap smears a day are completed by overloaded clinics, which see around 1,000 patients a day.

Where there are abnormal results, ROSE enables patients to phone a dedicated number and ask questions before being redirected to a government hospital. Referrals are swift and painless.

“In most public healthcare facilities after a pap smear, whether in public hospitals or clinics, the nurses tell the women, ‘if you don’t hear from us, that’s good news’. But because they are so busy, I have seen them slip through the net with abnormal results,” says Dr Woo.

“So what this solution or the registry does is ensure a closed loop for that particular woman. That’s essentially the ROSE solution.”

Dr Woo has proposed that the Health Ministry works with the National Registration Department so that ROSE can track all women and start the cervical cancer screening process for them once they hit 35.

“I see the devastating effects of cervical cancer on women and their families,” says Dr Woo. “By integrating the latest technologies in a human-centred approach, cervical cancer can now almost entirely be prevented. I am hopeful we are taking another step forward towards protecting more women.”

The Importance of IP

As a digital health programme, intellectual property (IP) rights influence nearly every step along the Project ROSE value chain.

Patents protect the innovations within the self-administering swab at the heart of the programme.

Swab data is handled via the VCS Foundation’s secure eHealth platform, canSCREEN. It sends results quickly by mobile and tracks each woman’s screening journey using a population health management platform.

Copyright protects the platform’s programmes and algorithms, and database rights protect the valuable data stored by the system as it flows between the different actors in the chain.

As Program ROSE shows, the digital sector is becoming an increasingly important part of the health landscape.

The development and deployment of digital health products and services such as Program ROSE involves a number of parties, often in different countries — in this case, Malaysia for the deployment, and Australia for the platform development and data management. The contracts and licensing of IP rights between the parties depend on IP laws that are harmonised across borders.

The WTO TRIPS agreement provides basic international standards for the protection of IP rights and negotiations are currently underway at the WTO for new international rules to govern digital trade, including e-health services. It is hoped these negotiations will result in a more robust policy framework for data to flow between providers and countries seamlessly and without any government-erected barriers, such as data localisation requirements.

As Program ROSE shows, the digital sector is becoming an increasingly important part of the health landscape. It promises to be revolutionary in countries that struggle with the expense of building and maintaining infrastructure for comprehensive health systems. But without proper IP protection and enforcement, the promise of digital health benefits will be lost.

[1] Malaysian National Cancer Registry Report 2007 to 2011

Published as part of the Innovate4Health initiative, a joint project of the Information Technology and Innovation Foundation (ITIF), Geneva Network, and the Institute for Intellectual Property Research.

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