The executive summary is yes, of course, you can. Well over 50% of the entire world's medication supply is generic and the majority of your patients will be taking one or more generic medications.

The caveat is, that, just as there are good quality and poor quality cars so too there are good quality and poor quality generics.

It should be reassuring to know that the clinical results of generic HCV medications have now been extensively validated and presented at International conferences such as EASL, AASLD and CROI.

In routine medical practice, doctors write words on a piece of paper and depend on a well-oiled supply chain machine to ensure that those words translate into the correct chemicals entering the patient's system.

When it comes to generics that are not licensed in your country the critical questions are:

  • Do they meet the quality standards we expect for generic registration?
  • Can they be sourced reliably?
  • Is it ethical and medicolegally defensible?

Quality Standards

There are two key quality standards that deliver dependable generics:

  • CGMP/GMP
  • Bioequivalence

CGMP/GMP

CGMP refers to the Current Good Manufacturing Practice regulations enforced the US Food and Drug Administration (FDA). GMP refers to the Good Manufacturing Practice regulations enforced by the European Medicines Agency (EMA). GMP systems assure the proper design, monitoring, and control of manufacturing processes and facilities.

CGMP and GMP are the quality control systems that ensure a manufacturer has the capacity to reliably mass produce medicines.

Bioequivalence

Bioequivalence is proven by a study that looks like this. A group of 24-48 people take a single dose of originator medication, and the blood levels of the drug(s) are measured at various time points over the next 24 hours. After a washout period, the same group then take the generic version and once again the blood levels of the drug(s) are measured. A drug is deemed bioequivalent when the blood levels at all time points are a statistically near identical match. Bioequivalence proves, not only do the tablets contain the active ingredient(s) in the correct quantity, but more importantly that they deliver these into the patient's system in the same was that the originator version does.

Reliable Sourcing

Sourcing medications via the Internet is unusual. How it can be done safely is covered in detail in our section on supply chain integrity.

FixHepC was established by a doctor, Dr James Freeman, so it should not surprise you that we have performed extensive due diligence to ensure that the generic medications patients source with our assistance are fit for purpose.

Ethics and Medicolegal Considerations

There is no doubt that originator drug companies have a right to make good profits for the risks they take. Looking at Sofosbuvir the innovators at Pharmasett made $11 billion dollars from a $281 million investment. Gilead simply bought the patent and has made over $50 billion dollars from their $11 billion dollar purchase. There is some academic analysis of this in Liver International article The use of generic medications for hepatitis C and at How many Hepatitis-C deaths does it take to make a billion dollars for a drug company?

When presented with a ethical or treatment dillema I use the mum test. What would mum think about me doing this, and would I give this treatment to my mum? FixHepC passes the mum test - Dr James Freeman

Given the key job of a doctor is to provide effective treatment to their patients, in the circumstances that a patient needs treatment, but can't access it, consideration should be given to the use of generics. This is most eloquently articulated in the NZ Society of Gastroenterology HCV Treatment Guidelines which notes:

Alternative access to DAAs may include:
- Import 12 weeks supply of sofosbuvir and daclatasvir or 12 weeks supply of sofosbuvir and ledipasvir for private use under a personal importation scheme (e.g. FixHepC Buyers Club (approx. $2,000–$3,000).
- Purchase HARVONI (ledipasvir/sofosbuvir) from Gilead Sciences without subsidy (approximately $75,000 excl GST per 3-month supply).
- Participate in a clinical trial with either next-generation DAAs or approved DAAs in difficult-to-treat populations.

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