Exploring the generic question

ARE GENERIC medicines really as good as big-name brands? It’s a question you might find yourself asking more frequently.

Globally, increasing numbers of “originator” drugs are coming off-patent and so making room for generic versions.

And in Ireland, pharmacists could soon be obliged to tell patients about cheaper generic alternatives to prescribed brands of medicine if a proposed scheme is put into action.

But how can you really be sure that a generic will work as well as the original drug that went through extensive development and clinical testing?

Any generic medication that’s seeking a licence in Ireland has to prove “bioequivalence”, explains Pat O’Mahony, chief executive of the Irish Medicines Board and chairman of the European Medicines Agency.

“The trials are done to very specific guides that are published at European level,” he says. “You administer the original and new medication and you compare the profile of the active ingredient appearing in the bloodstream, and that has to be equivalent.”

If the regulators then give a generic the thumbs-up for a licence, it will be subject to the same ongoing safety monitoring for adverse reactions as any other medication on the market, according to O’Mahony.

However, while the active ingredient in a generic may be bioequivalent to the originator drug, the non-active ingredients can differ, and O’Mahony says patients need to look at the documentation that comes with medications or talk to their pharmacist.

“There might be a carrier of lactose in a tablet and someone may be lactose intolerant. Those small differences can crop up,” he says.

Some types of drugs are generally not suitable for generic substitution – including epilepsy medications – and there will be cases where a doctor wants to keep a patient on an originator drug for medical reasons, adds O’Mahony.

But he stresses that care needs to be taken when switching to generics so that it doesn’t confuse people and result in medications being taken inappropriately.

“You quite often have elderly people who have a complicated medication regime, they may be on a range of tablets every day,” says O’Mahony. “There has to be a specific regard for those patients where the generic looks or feels different.”

Such switching could happen more frequently under a scheme outlined in a report to the Department of Health in May that, if implemented, would in many cases oblige pharmacists to tell patients about cheaper substitutes if the doctor has prescribed a more expensive brand.

That scheme would set a “reference price” for the lowest-cost drug in a given class and if a patient wanted to opt for the more expensive equivalent under the GMS or drug payment scheme, then the consumer would have to fork out the difference in price.

Referencing and substitution would stand to “deliver significant ongoing savings”, according to the report, which was prepared by an expert group.

But the Irish Pharmaceutical Healthcare Association (IPHA) – which represents many manufacturers of originator drugs – has issues with the approach.

Frequent resetting of reference prices could potentially threaten supply if companies were to decide that Ireland was no longer an economically viable market for them, according to Brian Murphy, director of commercial affairs with the IPHA.

“When we are talking about medicines we are talking about something very different from a box of cornflakes. If a box of cornflakes is not available this week in the supermarket it’s unfortunate but it’s not a life or death issue,” he says. “On the other hand, if the medication a patient is on isn’t available that’s a huge problem, particularly for long-term medication.”

Murphy also expresses concern over patients being less likely to comply with medication regimes if they are frequently switched on to different products, and he says it’s unclear how much the scheme would cost to implement: “I don’t think is going to deliver what the State believes it’s going to deliver.”

Already the research-based pharmaceutical industry has negotiated price reductions with the Government and the generics manufacturers are also in discussions, and Murphy sees this approach as potentially a better route for the State to get value for money.

So what about the generics companies? “We would welcome any method that allows us to increase our volume – we can give additional value to both patients and taxpayers once the volume is increased,” says Sandra Gannon, chairwoman of the Association of Pharmaceutical Manufacturers in Ireland, which represents several generic manufacturers, and managing director of Teva Pharmaceuticals Ireland.

The generics industry is highly regulated, according to Gannon, and she has fewer concerns over the security of supply under the proposed referencing and substitution scheme. “Most of the generic manufacturers are multinational companies and most are operating in tender markets already – and by and large there are no problems of continuity of supply.”

In response to questions from The Irish Timesabout the proposed scheme, the Department of Health says: "Security of supply will be a key consideration for the HSE when setting and adjusting reference prices.

“Patients can be confident that under the proposed system that any medicine that has been designated as interchangeable can be safely substituted.

“The proposed model limits the number of times the reference price may be changed per year to avoid frequent changes for patients. Adjusting the reference price will allow patients and taxpayers to benefit from price competition between suppliers of interchangeable medicines.”

And on the cost of implementing the scheme: “The HSE already has an administrative system in place for accepting medicines for reimbursement, pricing medicines, reviewing prices and implementing off-patent price cuts. The proposed system is not expected to impose any significant additional administrative burden on the HSE.”

But while the details of any plans for generic referencing and substitution get hammered out, Prof Moira O’Brien, founder of the Irish Osteoporosis Society, would like to see more extensive testing of generic drugs for side effects before they are even put on the market.

“Most of the branded [drugs] have done three or four years studies involving thousands of patients, and very often you don’t get the side effects until you have done it for six months or a year,” she says.

O’Brien also points out that doctors can write on a prescription form that no substitute drug should be given. “It’s the doctor who knows the patient,” she says.

WHAT IS A GENERIC MEDICINE AND HOW DOES IT GET APPROVAL?

Medicines are expensive to develop. A pharmaceutical company may spend hundreds of millions of dollars going through the process of “discovering” and developing a drug, testing it in pre-clinical and clinical trials and convincing national regulators that the medicine is safe and effective.

Taking out a patent can protect that investment, because it means that no one else can make a profit from making or selling that particular drug.

But patents run out, and when they do, other manufacturers can put “generic” versions of the original medicine onto the market.

Generics can cost less than the original drug because they haven’t needed to go through the same long-haul discovery, development and testing processes.

But they still have to prove they are “bioequivalent”, they still need to be approved for use by the national regulator (in Ireland that’s the Irish Medicines Board) and they are monitored for adverse reactions just as with any other medicine on the market.