China's current ARV choices are severely limited due to patent restrictions
Domestically made drugs: Didanosine (ddI), Stavudine (d4T), Nevirapine (NVP), and Zidovudine (AZT)
*ddI-d4T is on US National Institutes of Health (NIH) 'not advisable' list (as of 10 Nov 2003)
*As a generic, ddI is only legally available in powdered form, which is even more difficult to take.
*NVP should not be used when patient has Hepatitis-B, which is a large % (10-20%) of people in China.
*None of the combinations available with domestically produced drugs are on the WHO list of recommended first-line treatment regimens.

Missing Element in China's treatment program
Lamivudine (3TC or Epivir®) is an important part of ALL first-line treatment programs. Epivir® is expensive, but generic versions world-wide are cheap. 3TC is well-tolerated, and has fewer side-effects than most ARVs. In most developing countries, some generic version is available. The cheapest such generic currently costs only US$65/year (from Hetero, India). 3TC as a single ingredient with a dosage for HIV/AIDS is NOT currently marketed in China, though it is patented by Glaxo (GSK). 3TC is only marketed (by GSK) together with AZT in a fixed-dose combination Combivir® (3TC150mg+AZT300mg).

How GSK and other big pharma are preventing access
*GSK only markets Combivir®. This marketing arrangement does not allow for proper treatment, because , in the case of bad reaction to AZT, patients must stop the 3TC as well as no proper, single 3TC is available. This compromises future treatments and paves the way for resistance to the virus.
*Many foreign pharmaceutical companies have registered their patented ARVs, but do not market them in China, which means domestic companies cannot produce copies but the drugs are not for sale.
*ARVs that have been registered but not put on the market are the following:
-GSK: AZT (but generics are available), Abacavir (ABC), 3TC single ingredient and the combination of the three (Trizivir®); 3TC is particularly important in "first-line therapy".
-Abbott: ritonavir and lopinavir/ritonavir;
-Roche: saquinavir
*Some companies that have registered drugs say that patients (or doctors) can arrange for import themselves [As one NGO worker explained: "Technically, a registered product can indeed be imported. There are however many constraints for the purchaser (additional costs, uncertainty on the final price, length of the procedure...), the importer (needs a legal status, burdensome administration...) and the manufacturer (requires Chinese labelling...)." ]

Global Fund money will be used to pay for expensive patented meds
*GF money is slated to pay for alternative and second-line therapies, 3TC, indinavir (IDV) and efavirenz (EFV). 3TC is GSK drug, IDV and EFV are MSD drugs. Since the proper HIV/AIDS formulation of 3TC is not currently marketed in China, it would most likely be used as Combivir® (AZT+3TC). At present, patented versions of evavirenz (EFV) costs US$1456/year from Merck, Indinavir (IDV) US$1620/year from Merck, and Combivir® US$2615/year from GSK, though there appear to be difficulties actually buying EFV and IDV in China.
By way of comparison, Chinese companies say they could market generic 3TC for about US$80/year, which if combined with the already available generic AZT would make the price for a generic AZT+3TC approximately US$175/year. Prices for generic EFV and IDV would also be much lower than the patented versions.

Proper ARV treatment requires flexibility and multiple drug options
Patients often do not tolerate one or another ARV, and for proper treatment it is essential that doctors have other choices to substitute another ARV. In China, using domestically produced drugs, the Ministry of Health plan calls for only two first-line combinations, d4T-ddI-NVP and AZT-ddI-NVP. By far the most important missing ARV, lamivudine (3TC) is currently unavailable as a single drug in China.

Compulsory Licensing
According to the WTO TRIPS agreement, China has the right to effectively override patents on 3TC and EFV by issuing "compulsory licenses" to domestic companies if such drugs are necessary for the public health. Contrary to what is often said about compulsory licensing, the actual TRIPS agreement does NOT require a country to declare a "public health emergency" in order to issue compulsory licenses. [see: http://www.wto.org/english/res_e/booksp_e/analytic_index_e/trips_02_e.htm#article31B ]

China has the capacity, and is in fact already producing many of the missing drugs
Desano(Shanghai), MChem(Xiamen), and other companies make raw materials (chemical ingredients) for export to countries like India and Brazil, and for sale to GSK and other international pharmaceutical companies. According to one company source, GSK now buys nearly completed 3TC from Desano in Shanghai, and only puts the final touches on the drug before selling it. According to a Nov, 2001 article in the China Daily, Glaxo already produces its hepatitis drug Heptodin® (3TC 100mg) inside China, where there is a big market for such treatment. Other domestic companies have registered and/or made Indinavir (IDV), and the tablet form of ddI in China, and more applications are in the pipeline. The ability is clearly there, just not the official permission

WHO "essential drug" ARVs not available in China
The WHO has included 12 ARVs (including one combination) in the WHO Model List that sets the minimum medicine needs for a basic health care system. China does not have such a list.
• In China as of today, only seven ARVs (including two combinations) are available locally and none of them with a paediatric formulation (when it exists).
• A the moment, the "WHO essential" ARVs that are not available are abacavir (ABC or Ziagen®) and lamivudine (3TC or Epivir®) from GSK, ritonavir (Norvir®) and the combination lopinavir/ritonavir (Kaletra®) from Abbott, as well as nelfinavir (Viracept®) and saquinavir (Invirase®) from Roche.