Officials to Crack Down On PrEP Imports Amid Concerns About Bogus Suppliers

The Health Products Regulatory Agency have ramped up their efforts to intercept generic PrEP, which is being sourced in Ireland through the iwantprepnow.co.uk website.

Prep HIV

“The important point out of all of these developments is if you are going to source PrEP, no matter how you do it, that you link in with sexual health services.”

According to the Gay Health Network (GHN), a service user contacted them recently to report that he’d received an alarming communication from the Health Products Regulatory Agency (HPRA), after a package containing PrEP he’d ordered through iwantprepnow.co.uk was intercepted.

Members the GHN intervened on the person’s behalf and met with the HPRA this week, who clarified their position.

“They flagged that they were concerned about the legitimacy of the supply chain and about the websites people are using to order PrEP,” says Adam Shanley of GHN, who was at the meeting. “There is extensive therapeutic drug management testing done on these drugs in the UK, so people who were advocating for its use there were very confident that this was a legitimate drug. Up until this week in Ireland we were all very confident in this drug as well.”

The website iwantprepnow.co.uk has been the ‘go to’ website for men who have sex with men (MSM) to source PrEP online and one of the suppliers Dynamix have been successful in supplying PrEP into Ireland.

Following the GHN’s meeting with the HPRA, National Clinical Lead for Sexual Health Services, Dr. Fiona Lyons also met with the agency.

“The HPRA are working with the drug manufacturer whose label is on it to see if it’s authentic, to see if it went on all its points of production from manufacture to supply,” she says. “According to the HPRA batch numbers can be stolen from some completely unrelated drug and it can be something completely other than you think it is. They raised a number of red flag issues, and some of those were around the packaging and handling and labelling of the medicines.

“They also expressed some concern with was around some of the websites that are cited on the iwantprepnow.co.uk website and whether they were authentic.”

According to Lyons, in light of the meeting, “we disseminated a message to clinicians in Ireland, reiterating the HPRA’s position and the law around the supply of medicines, and that they really strongly encourage the public not to engage with buying PrEP online because they may come to harm.

Difficult Position

“It puts the clinicians in a difficult position because as doctors at this stage we can’t include a conversation around HIV prevention that doesn’t include PrEP, because categorically it’s part of a combination HIV prevention approach.

“We have had to say to clinicians not to actively refer people to iwantprepow. It’s a very difficult position to be in because where else can we refer people, when we know people are doing this?”

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It is currently illegal to supply medicines to Ireland by mail order, and it is also illegal to source prescription medicines without a prescription, however both Lyons and Shanley want to make it very clear that the HPRA will not be charging or convicting people who source PrEP online.

“Anyone would be a bit scared by the information that was requested by the HPRA of the individual who got in contact with GHN, but categorically the HPRA’s objective is not to charge people. They want to find information about the suppliers, because they would actually try to shut down rogue suppliers, of which they say there are many. This is not exclusive to PrEP, there is a big market for drugs like anabolic steroids, medication for erectile dysfunction, and cancer drugs.

“The HPRA say that some of the stuff is really dodgy, counterfeit medicines, poor quality and not legitimate, and they want to shut down bogus suppliers. There are going to be opportunists out there who see an opportunity here to make money.

“That’s obviously a huge concern for all of us.”

Know The Risks

Despite previous understanding based on UK testing, according to Shanley GHN has a responsibility to let the community know about the HPRA’s concerns.

“The position of the community advocates is that if there is any doubt whatsoever, we need to ensure we act fast and get that kind of communication out to the community as soon as possible.

“We don’t know much more at this point, but what we have a responsibility to do is to ensure that the community know the risks. It’s also important to say that the HPRA are much more aware of this now, they are putting more resources into intercepting packages.”

Meanwhile movement on making PrEP available in Ireland continues to be slow. Last March GHN released a community statement calling on the Irish government to make PrEP immediately available and accessible, at no financial cost, to those vulnerable to, and at substantial risk of, HIV infection.

In Ireland, HIV remains an infectious disease of major clinical and public health importance in Ireland, while MSM are disproportionately affected by HIV. New HIV diagnoses among MSM increased fourfold between 2005 and 2015, and now account for more than half of all new HIV diagnoses.

According to GHN, “PrEP has an extensive evidence-base, which proves its efficacy as a safe and highly effective way for HIV-negative people to prevent HIV. Making PrEP available and accessible to those at highest risk of HIV infection can reduce the rate of new transmissions dramatically.”

“No matter what, the reality is that people who need or want PrEP tend to be those who are in need of that extra level of protection, so they’re possibly the most vulnerable to HIV infection in the community,” says Shanley. “We know that no matter what information you put out there, people are going to want to access it.

“The important point out of all of these developments is if you are going to source PrEP, no matter how you do it, that you link in with sexual health services. The services are not there to encourage you not to source PrEP or take it, they’re there to make sure you’re taking it correctly, you’ve had the correct tests, and you’re having ongoing monitoring.”

“The services are not interested in taking cases against people, they’re just interested in ensuring the safety of individuals,” says Lyons. “If people are taking bogus drugs and they think okay from a HIV point of view, and they’re not, and they contract HIV themselves and then transmit it to others, that would be a huge public health problem.”

“People should also contact the health services to ensure that they’re taking the medication properly, so they can avoid potential exposure.”

 

For Man2Man’s advice about sourcing PrEP online, click here. To find out about your local sexual health services visit the man2man website

 

© 2017 GCN (Gay Community News Ireland). All rights reserved.

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