Online Pharmacies' Issues On Drug Dispensing: Legal, Regulatory, Ethical

Online Pharmacies’ Issues on Drug Dispensing: Legal, Regulatory, Ethical
Adrien Kyle M. Jacinto, RPh, MS Pharm (Ph. Chem.) On-going* |Atty. Froilan A. Bagabaldo, RPh
College of Pharmacy | University of the Philippines Manila | 23 May 2018
Online pharmacy services refer to pharmaceutical services of a duly licensed

pharmaceutical outlet done over the internet (RA 10918). This is similar to community
pharmacies, but the difference is the method by which medications are requested and received.
Ordering medications online have many benefits, such as lower prices and convenience when
ordering medications, privacy, and medical information. However, it also has the potential risks,
such as high chance of counterfeiting since drugs are not dispersed though licensed pharmacies,
personal and financial information not adequately protected, additional fees added to the drug
price, drug prices change quickly, and distribution of medications can be extremely dangerous if
not taken under medical supervision.
Pharmaceutical Security Institute-Asia Pacific (2014) cited the top ten countries with the
most number of cases of medicine counterfeiting from year 2011-2013. China has the most
number of cases (712), followed by Japan (217), Pakistan (237), South Korea (154), Indonesia
(141), India (108), Taiwan (79), Philippines (50), Thailand (34), and Vietnam (27). Particularly in
the Philippines, high number of cases were recorded from NCR (49%), Cebu (11%), Laguna (11%),
and other regions (29%). Cases were mainly due to illegal diversion (i.e., a genuine
pharmaceutical product approved and intended for sale in one country is illegally intercepted
and sold in another country). PSI-Asia Pacific director Samson Chiu said the top three fake drugs
being sold were cardiovascular, metabolism (HRT) and anti-infective medicines mostly originated
from China and India.
According to FDA Philippines, the proliferation of online pharmacies as a means of cyber

drug trade complicates the fight against unregulated selling of drugs, including counterfeit
medicines. Proliferation is mainly due to many Filipinos patronizing them. Particularly, Former
FDA OIC Nicolas Lutero III said that they are facing a problem with internet pharmacies since a
lot of medicines being sold through the internet from different websites are difficult to monitor.
Although FDA have control over local online pharmacies (i.e., they must have license before
operating), the agency was powerless against those based abroad. Powerless because they
cannot run over them simply because they do not violate the Philippine laws since they are
operating overseas. The DOH also stated that the problem with counterfeiting may only worsen
with the prevalence of online pharmacies. Moreover, the WHO stated that in over 50% of cases,
medicines purchased over the internet from illegal sites that conceal their physical address have
Jacinto, A.K. & Bagabaldo, F.A (2018). Online Pharmacies Issues on Drug Dispensing: Legal, Regulatory, Ethical. UPCP, 1(1): 1-19
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been found to be counterfeit. Cebu Rep. Antonio Cuenco Jr., on the other hand, sees internet as
a new dimension in the fight against dangerous drugs. It is a scam prone transaction and supports
drug trafficking since internet gives a recipe on how to protect one entity against law
enforcement. Additionally, the problem with online pharmacies is that it comes from over the
place and in different forms, so no single government can tackle this issue on unregulated selling
of drugs. Hence, it is a global public health and international concern.
In 2005, a cross-sectional study was performed that examined 275 English-language web
sites located using the search engines Google and AltaVista with the keywords “prescription
drugs” (Littlejohn C. et. al., 2005). Based on their investigation, the authors grouped Internet
pharmacies selling prescription medications into four distinct categories: Legitimate – provides
medication as extension of established brick-and-mortar pharmacy, contingent upon patient
possession of a valid medical prescription; Subscription – advertise online access to pharmacies
selling prescription-only drugs without a prescription in return for a subscription fee paid online
with credit card; Lifestyle – supply “lifestyle drugs” (e.g., erectile dysfunction, obesity, or male
pattern baldness) directly to the patient after being issued a prescription though an ‘online
consultation’; and No-prescription – offer mail-order delivery of drugs e.g., opioids,
benzodiazepines and methylphenidate without a prescription in return for online credit card
payment. These categories of internet pharmacies speak to the fact that when compared with
traditional pharmacies, buying prescription medication online is truly a matter of caveat emptor
(the principle that the buyer alone is responsible for checking the quality and suitability of goods
before a purchase is made).
Currently, it is unknown how many pharmacies are doing business over the internet but
estimates of the industry range from US$ 50 to 75 billion. Nevertheless, this review aims to
analyze and compare the different laws and regulations of 6 different countries: Philippines, USA,
Australia, Japan, China, and Thailand regarding online pharmacies and to identify the gaps in the
implementation of regulations on online pharmacies. Lastly, this also aims to identify the ethical
issues linked to illegal online pharmacies. The table below provides an overview of the different
countries regulation on selling prescription drugs online.
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Overview of Different Countries’ Regulations on Selling Prescription Drugs Online
Philippines USA Australia Japan China Thailand

Online No (No online
Yes (No law
Pharmacy No (Only for type 2 pharmacies can
Yes Yes that No
permission and 3 OTCs) comply with the
prohibits)
old law)
Physical
location of
dispensing Within Within Within N/A N/A N/A
online
pharmacy
Legal (as long as for

personal use, in
quantities or volume
specified in
Legal, with
prescription with
limitations
corresponding
(Japanese citizens
Physician’s PRC license
are allowed to Illegal (Personal
No. or its equivalent (in Legal (as
import 1-month importation is
case of foreign long as
supply of Japan- extremely limited,
physician), and is importer has
approved mostly medical
Importation brought in the Illegal valid Illegal
prescription practitioners
Philippines thru Australian
medication; drugs importing meds to
passenger baggage, Dr.-Issued
personally a particular
Balikbayan boxes, or prescription
imported into patient)
parcels)
Japan do not
necessarily have to
Joint Circular No. 1
be approved
(importation of FDA-
DOH (BOC) regulated
products for personal
use)
Illegal (only
exception
is for Utah:
Procurement applies only if
of drug by just pharmacy,
Illegal Illegal Illegal Illegal Illegal
filling online online doctor,
form and patient
are all in Utah
– and is only
for few drugs)
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PHILIPPINES
RA 10918 also known as the “Philippine Pharmacy Act” was published in the official
gazette last May 15, 2017 and took effect on May 30, 2017. This newly established law stated the
following rules and regulations which directly affect the practice of online pharmacy in the
country:
• Whether in-store or online, Category A pharmaceutical establishments or outlets shall be

supervised by a pharmacist in order to dispense prescriptions and pharmacist-only
medications. The direct and immediate control and supervision is required for Category
A pharmaceutical establishments or outlets due to the nature of the pharmaceutical
product that will be dispensed or the kind of service that will be provided. Moreover,
virtual pharmacy without physical outlet is not allowed (Rule 4, sec. 7 – Pharmacist
requirement).
• Telepharmacy and online services of FDA-licensed drugstores/pharmacies/boticas and
hospital pharmacies, RONPDs (Retail outlet nonprescription drugs), and institutional
pharmacies are allowed subject to rules and regulations of FDA. (Rule 4. Sec 14 –
Requirements for opening and operation of a retail pharmaceutical outlet or
establishment)
• Unauthorized dispensing of pharmaceutical products by a professional through
unregistered online services or direct selling businesses, in accordance with the guidelines
issued by FDA and BOD – PRC, will lead to revocation or suspension of COR (for Registered
pharmacist) or cancellation of STP (for Foreign pharmacist) by the board upon notice or
hearing (Rule 6. Sec. 3 – Violations and Administrative Sanctions)
• Any person operating an unlicensed pharmaceutical outlet such as online pharmacy
service or direct selling not authorized by the FDA will lead to penalty amounting nlt
250,000 - nmt 500,000 Php, Imprisonment of nmt 1 yr & 1 day - nmt 6 yrs, or both, upon
discretion of court
The FDA, though RA 3720 also known as the “Food, Drugs and Devices and Cosmetics
Act”, was mandated ‘to regulate establishments engaged in health products to ensure consumer
safety, welfare protection, and fair practice’, as amended by RA No. 9711 (FDA Act of 2009), RA
No. 10611 (Food Safety Act of 2013), and RA No. 9502 (Universally Accessible Cheaper and
Quality Medicine Act of 2008). This regulatory body, though FDA Advisory 2013-063, issued a
Public warning against health scams in the internet, and some of those are the following:
• 4. When buying medicines on-line, make sure that the seller has valid FDA License to
Operate (LTO). It is against FDA laws to sell medicines (OTC or prescription) without LTO
and without a licensed pharmacist.
• 5. Make sure that a licensed pharmacist is available to provide the patient with advice on
prescription drugs. Sellers of prescription drugs whether or not online are required to fill
orders upon prescription.
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• 6. Beware of online pharmacies that do not indicate physical address or toll-free phone
number to contact in case of a problem or ADR. These online pharmacies are hard to track
down for purposes of traceability or may be illegitimate online pharmacies. Buying
medicines from illegitimate sources may expose you to counterfeit drugs. Counterfeit
drugs are ineffective, harmful and dangerous to your health.
Although we have legal provisions that regulate the importation and exportation of
medicines, such as the RA 9711 (FDA act of 2009) and RA 3720 (FDDC), the FDA and our current
provisions are still not sufficient to regulate online pharmacies overseas from selling
pharmaceutical products to our country. This is the main reason why the FDA campaigns to
prevent consumers from purchasing drugs overseas via online pharmacies. This issue is also a
problem of almost all countries. Moreover, the RA 10175 otherwise known as the ‘Cybercrime
prevention act of 2012’ is also lacking when it comes to the sale of products and services bought
online. This law is only concerned when the transaction is unsolicited or no prior affirmative
consent from the recipient which, I think is impossible for online pharmacies.
Important websites:
www.fda.gov.ph To verify if the health product/online
pharmacy has a valid license
report@fda.gov.ph To report counterfeit drug or adverse reaction

encountered after taking the drug bought
online
http://www.fda.gov.ph/fda-corner/policy- To download the consumer-friendly manual
planning-service/iec-materials/376794-the- on buying health products online
abcde-s-of-buying-health-products-online
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UNITED STATES OF AMERICA
Online Pharmacy, as per HR 6353 otherwise known as the ‘Ryan Haight Online Pharmacy
Consumer Protection Act of 2008,’ means a person, entity, or internet site, whether in the US or
abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts
to deliver, distribute, or dispense, a controlled substance by means of the internet. This act
amended the Controlled Substances Act (21 USC 802) to address the online pharmacies; designed
to combat the rogue internet pharmacies that proliferated in the late 1990s, selling controlled
substances online. Moreover, it also prohibits US online pharmacies from supplying controlled
substances to anyone without a valid prescription from a doctor he/she met with at least once.
Hence, it is required to have a face to face physician encounter prior to the issuance of a
prescription for a controlled substance. Nevertheless, the following below are some of the rules
and regulations stated by the law which affect the practice of online pharmacy in the US:
• No controlled substance that is a prescription drug as determined under Federal Food,

Drug and Cosmetic Act may be delivered, distributed, or dispensed by means of the
internet without a valid prescription. (Sec. 2 – Requirement of a valid prescription for
controlled substances by means of the internet, e1)
• Additional requirements relating to online pharmacies and telemedicine (Sec. 311):
a) An online pharmacy shall display in a visible and clear manner on its homepage a
statement that it complies with the requirements of this section with respect to
the delivery or sale or offer for sale of controlled substances and shall at all times
display on the homepage of its internet site a declaration of compliance according
to this section.
b) ...complies with state law concerning licensure of online pharmacies
c) … online pharmacies shall disclose the following information in its homepage:
§ Name and address (as it appears on the pharmacy’s Drug Enforcement
Administration COR)
§ Telephone number and email address
§ The name, professional degree, and States of licensure of the pharmacist in
charge (as well as telephone number)
§ A list of states in which the pharmacy is licensed to dispense controlled
substances
§ COR to dispense controlled substances
§ Name, address, telephone number, professional degree, and the states of
licensure of any practitioner who has a contractual relationship from the
website
§ The following statement, unless revised by Atty. General by regulation
• Offenses involving dispensing of controlled substances by means of the internet are the
following. Offenders will be penalized of a fine amounting $500,000 (if the defendant is
an individual) or $2,500,000 (if the defendant is other than an individual) or an
imprisonment of nmt 10 yrs or of nmt 15 yrs (if death or serious bodily injury results from
the use of such substance), or both. (Sec. 401).
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a) unlawful delivery, distribution, or dispensing of controlled substance by means of
the internet (ex. Not validly registered online pharmacy)
b) aid or abet such as:
§ Writing a prescription for a controlled substance for the purpose of dispensing
by means of the internet in violation of section 309(e);
§ Serving as an agent, intermediary, or other entity that causes internet to be
used to bring together a buyer and seller to engage in dispensing of controlled
substance in a manner not authorized by sections 3039(e)(b).
In the US, it is also illegal to purchase controlled substances from online pharmacies
operating overseas. In 1999, the US National Association of Boards of Pharmacy (US NABP)
launched an approved online pharmacies verification program called VIPPS (Verified Internet
Pharmacy Practice Sites) to prevent all non-US online pharmacies that sell prescription
medications to Americans, and regardless of credentials, are not eligible for approval. As of
September 2010, the LegitScript.com, which is also another verification and monitoring service
program for online pharmacies recognized by NABP, had approved over 340 Internet pharmacies
as legitimate and identified over 47,000 "rogue" Internet pharmacies. The US FDA refers internet
users interested in using online pharmacy to these programs since these programs verify internet
pharmacy legitimacy. Moreover, Last 2014, the US FDA in partnership with other federal and
international agencies and technology companies like Google, took action against illegal online
pharmacy websites. Additionally, PharmacyChecker.com collects, evaluates, and reports
credentials (e.g. Pharmacy license, DEA-issued license for controlled substances, and privacy
policy contact information), prices, and customer feedback regarding online pharmacies as it
requires and verifies that online pharmacies abide the requirements of Ryan Haight Act.
Important websites:
https://www.legitscript.com To verify Internet pharmacy legitimacy
www.nabp.net/programs/accreditation/vipps/.
www.nabp.net/boards-of-pharmacy. To verify pharmacy licenses in the US
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AUSTRALIA
Currently, there is no Australian jurisprudence on virtual drug distribution. However,

many existing requirements applying to physical pharmacies will also apply to those operated
online. Accordingly, Therapeutic Goods Act of 1989 provides the following provisions:
• Products is required to be entered on the Australian Register of Therapeutic Goods

(ARTG). Registered medicines having an AUST R number on the label or packaging are
classified as high risk medicines by the Therapeutic Goods Administration (TGA). This
include the Prescription-only medicines which may be dispensed only on presentation of
an original physical prescription signed by hand by a doctor holding an Australian provider
number.
In any case, to purchase or import a prescription medicine in Australia, a patient must
have a valid Australian-issued prescription. Online pharmacies have attempted to deal
with this by requiring the prescription to be posted to the pharmacy or handed to the
courier in return for the medicine.
• Illegal obtaining of prescription only medicines / declared substances (i.e., pharmacist
only medicines, prescription only medicine, controlled medicine, dangerous poison,
prohibited substance) by an unauthorized person will lead to a maximum of 50 penalty
units (for prescription only medicines) or 200 penalty units, 2 yrs or more of
imprisonment, or both (for declared substances). (Sec. 35 – Obtaining certain declared
substances)
• Illegal possession of declared substance will lead to a maximum of 200 penalty units, 2
yrs imprisonment, or both (Sec 36. – Possessing certain declared substances)
In addition, both wholesalers and pharmacies are highly regulated in Australia and are
required to hold relevant licenses. This regulatory regime helps maintain the integrity of the drug
distribution system. Although the TG act provides for a number of offences that is likely to make
virtual drug distribution unlawful in Australia, the limits of the provisions have not yet been
tested in the context of drug distribution networks. Nevertheless, the TGA issued a statement
that when purchasing online, the site should provide an Australian street address and telephone
number.
Interestingly, Australia has a “Personal Importation Scheme”. Under PIS, you may import
a 3-month supply at one time (at maximum dose recommended by manufacturer) of
UNAPPROVED therapeutic goods into Australia without any approval by TGA provided that:
• The goods are for your own treatment or the treatment of your immediate family; and
• you do not supply (sell or give) the medicine to any other person; and
• where possible, you keep the medicines or medical devices in their original packaging with
any dispensing labels intact; and
• the goods are not restricted under Australian Customs controls or quarantine rules and
the goods do not contain a controlled substance; and
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• the goods are not injections that contain material of human or animal origin (except
insulin); and
• the total quantity of the goods imported within a 12-month period does not exceed 15
months’ supply of the goods (for medicines, at the maximum dose recommended by the
manufacturer); and
• if the goods are medicines in Schedule 4 or 8 of the Poisons standard, a prescription from
an Australian-registered medical practitioner is held for the medicines.
If someone wish to bring more than 3-months at one time into Australia, and Australian
registered doctor will first need to apply to the TGA for Special Access Scheme approval.
Important websites:
www.tga.gov.au/community-qa/buying- Provides general information about
medicines-and-medical-devices-over- restrictions on purchasing medicine online
internet.
www.tga.gov.au/personal-importation- Provides information about Australia’s
scheme#.UqJAs2RDt5W personal importation scheme
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JAPAN
Act No. 145 otherwise known as ‘The Pharmaceutical Affairs Law of 1960’ regulates the
manufacturing, importation, and sale of drugs and medical devises in Japan. Some of its
provisions are the following:
• Drugs aka “Iyakuhin” are classified into 3 (Art 4.):
a) Pharmacy drugs – Includes prescription drugs (drugs intended for use by a
physician or dentist or under the prescription or instructions of a physician or
dentist)
b) Guidance mandatory drugs – Designated by MLHW as drugs which clinical effects
are not as significant as prescription drugs and intended to be selected and used
by the consumer based on information provided by the pharmacist, etc. and must
be sold via face-to-face consultation with a pharmacist
c) Non-prescription drugs – Those in which clinical effects are not as significant as in
prescription drugs and which a consumer may select and used based on
information provided by pharmacist, etc.
• No one shall establish a pharmacy without a license from the governor of the prefecture
where the pharmacy is located. The license mentioned shall become invalid unless it is
renewed every 6 years. (Chapter 3, Art. 5 – Pharmacies)
• No proprietor of a pharmacy and no seller of drugs shall sell or give drugs so designated
by the Minister to persons other than those who have received a prescription or
directions from a physician, dentist or veterinarian. This shall not apply when such drugs
are sold or given to a pharmacist, a proprietor of a pharmacy, a manufacturer or seller of
drugs, a physician, dentist or veterinarian or a proprietor of a hospital, clinic or veterinary
clinic. (Chapter 7, Sec. 2. – Handling of Drugs – Sale of drugs requiring directions or
prescriptions, Art. 49)
• No following drugs shall be sold or given, or manufactured, imported, stored, or exhibited
for the purpose of sale or giving: (Art. 56)
a) Drug listed in JP (Japanese Pharmacopoeia) and for which quantity or properties
are not in conformity with established standards
b) A drug which is approved according to the provisions of Article 14 or Article 19-2,
but whose ingredients or quantities (if active ingredients are not unknown, the
essence thereof or outline of manufacturing methods) are different from the
details approved) (Excluding the cases which are not in violation of Article 14,
Paragraph 10(including cases where it applies mutatis mutandis under Article 19-
2, Paragraph 5);
c) A drug designated by the Minister based on specified standards pursuant to the
provisions of Article 14, Paragraph 1 or Article 23-2, Paragraph 1 for which the
ingredients or quantities(if active ingredients are not unknown, the essence
thereof or outline of manufacturing methods), properties or quality do not comply
with the standards
d) A drug for which the standards are laid down under the provisions of Article 42,
Paragraph 1 and which is not in conformity with the standards [excluding the
standards specified in Article 50, Item (7) and Article 52, Item (3)]
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e) A drug, the whole or a part of which consists of any impure, putrid or decomposed
substance
f) A drug in or on which any foreign matter is found
g) A drug which is contaminated, or is likely to be contaminated, by pathogenic
microorganisms
h) A drug which bears or contains, for the purpose of coloring only, any coal-tar
pigment other than those laid down by MHW ordinance.
Nevertheless, Article 56 may be exempted or other required exemptions may be

specified by cabinet order.
• Any person who violated the Article 5 (i.e., operating illegal online pharmacy), Article 49
(i.e., illegal selling of prescription drugs online), and Article 56 (i.e., illegal
dispensing/importation of drugs not in conformity) will lead to penal servitude not
exceeding 3 yrs or fine not exceeding 2,000,000 yen, or both.
• No person shall, explicitly or implicitly, advertise, describe or circulate false or
exaggerated statements regarding the name, manufacturing process, indications and
effects or properties of drugs, quasi-drugs, cosmetics or medical devices. Any person who
violated will lead to penal servitude not exceeding 2 years or fine not exceeding 300,000
yen, or both.
Moreover, the Pharmaceutical Affairs law has been partially amended by Law No. 69 of
2006 and Law No. 103 of 2013. The former, which became effective last June 2009, have changed
the marketing of OTC drugs in Japan for the first time in 46 years. Aside from revising the OTC
drug selling system, it also strengthen the control of illegal drugs. This partial amendment
allowed the retail of OTC drugs without prior consultation or prescription, and thus were readily
available throughout regular retail store. Particularly, non-prescription drugs in Japan are further
classified as follows:
• Type I – Highly risky medications and can be sold only through pharmacies. This include
Hair growth medications like Minoxidil (Rogaine), and H-2 blocker stomach medicines
such as Pepcid.
Under the law, Pharmacies that sell type I drugs must have their pharmacists provide to
the buyer drug information that is specified by Ministry of Health, Labour and Welfare
(MHLW) ordinance.
• Type II – Moderately risky medications and can be sold through registered OTC drug
sellers. These include fever reducers, such as Tylenol and Vitamin A.
When type II drugs are sold, a pharmacist or a registered OTC drug seller must try to
provide the drug-related information to the buyer, but is not obligated to make sure the
attempt is successful. If a buyer declines to receive the information, the pharmacy does
not have to provide the information
• Type III – Relatively low risky medication and like type II, can also be sold through
registered OTC drug sellers. These include vitamin B and C and common eye drops.
Pharmacies do not have to provide information relating to type III drugs at the time of
sales unless buyers ask questions.
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Although stores in Japan are now permitted to sell certain OTC drugs without having a
pharmacist, they can only market type 2 and type 3 non-prescription drugs provided they have
valid licenses as drug retailers (i.e., as store-based drug sellers or as drug sellers by household
distribution). The law, however, continued to ban internet sales of OTC drugs, which the ministry
of health had previously justified by stating that drug sales should only be conducted in person
by pharmacists.
The latter partial amendment, which became effective last June 12, 2014, clarify the
internet retailing rules of non-prescription drugs and tightens the regulations on designated
drugs/substances. This law introduced the internet retailing of OTC drugs in Japan stating that
non-prescription drugs may be retailed in the internet only if these are also marketed in an actual
store with an applicable marketing business license.
For the importation of drugs, Japan allows one to import up to 1-month supply of
prescription medication, and up to 2-month’s supply of non-prescription drugs without
completing any paperwork. Same rule applies to mailing prescription. The interesting point here
is the most prescription drugs are permitted, including drugs that may not be available in Japan,
such as birth control pills. However, drugs that are hallucinogenic, narcotic, and/or psychotropic
in nature will be confiscated, except in extenuating circumstances where prior approval has been
obtained (e.g., a cancer patient taking a type of medication that has a high percentage of pain
killer; these cases are treated on a case by case basis). Hence, it is always a good idea to have a
copy of the prescription and/or letter from the prescribing physician explaining the nature of the
medication, the purpose of taking it, recommended dosage, and frequency of ingestion.
Important websites:
www.law.egov.go.jp/htmldata/S35/S35HO145.html Japan’s pharmaceutical Affairs Law
www.mhlw.go.jp/bunya/iyakuhin/ippanyou/131218- Recent revisions of the laws and
1.html regulations
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CHINA
State FDA No. 480 of 2005, otherwise known as the ‘Interim Provisions on Examination
and Approval of Internet Drug Transaction Services’ are formulated in order to strengthen the
supervision and management of pharmaceuticals and to regulate the trading of Internet
medicines. (Art 1). It defines Internet drug trading services as e-commerce activities of providing
the trading services of pharmaceutical products (including medical devices, packaging materials
and containers in direct contact with pharmaceuticals) via the Internet. It Include services
provided for Internet drug trading between drug manufacturers, drug-holding enterprises
(pharmaceutical manufacturing enterprise and drug wholesaler enterprise) and medical
institutions. (Art. 2). Nevertheless, some of its provisions are the following:
• Enterprises engaged in Internet drug transaction services must undergo examination and
acceptance and obtain the qualification certificate of Internet drug trading service
institutions (valid for 5 years). The acceptance standards of Internet drug transaction
service institutions shall be uniformly formulated by the State Food and Drug
Administration (Annex 1). (Art. 4)
• Failure to comply with Art. 4 i.e., Operating with no certificate and/or expired certificate
will be punished. For minor offense, FDA shall order correction within a given time limit
and give a warning while for major offense, the offender will be punished in accordance
with relevant laws and regulations. (Art. 28)
• An enterprise that provides Internet drug trading services to individual consumers may
only sell the non-prescription drugs that are run by the enterprise online and may not sell
the drugs to other enterprises or medical institutions. (Art. 21)
• Unauthorized internet drug trading of unapproved drugs by enterprises or
establishments will be punished in accordance with relevant laws and regulations.
Moreover, drug trading service institution’s qualification will be withdrawn and internet
drug trading service institution’s credentials will be cancelled. (Art. 30)
• Unauthorized internet drug trading of prescription drugs to individual customers, or
selling medicines to other enterprises or medical institutions by a drug retail chain will be
punish according to relevant laws and regulations. Moreover, qualification will be revoked
and certificated will be cancelled. (Art. 31)
Interestingly, China have issued Ministry of Health Order No. 66 of 2009 to provide
measures for the administration of internet healthcare information services. As per this order,
the following activities are not permitted: (Chapter 3, Art. 12)
• Publish information containing feudal superstitions and obscene contents
• Post false information
• Publish medical advertisements without approval
• Engage in online diagnosis and treatment activities
For minor offense, the administrative department of Chinese shall give warning and order
corrections within a prescribed period of time. For serious offense, the offender will be penalized
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of a fine amounting nlt 3,000 yuan but nmt 10,000 yuan (for non-profit internet healthcare
information service provider) or 10,000 yuan (for commercial healthcare information service
provider) and if refused to correct and/or constituted a crime, will be transferred to judicial
department and held criminally responsible. Hence, to buy prescription drugs, patients must be
physically examined since online diagnosing and treatment activities are not permitted.
For the importation of drugs, China have strict regulations and the importation must go
through a rigorous approval process. Accordingly, the Drug Administration Law stated that drugs
that are imported without permission are treated as “counterfeit drugs.”
Important websites:
www.sfda.gov.cn/WS01/CL0060/9432.html China’s prohibition on selling
prescription drugs online
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THAILAND
B.E. 2510 of 1967, otherwise known as the Drug Act of Thailand, does not directly
prohibited internet pharmacies. However, since selling of drugs online would violate the
provisions of the law, no internet pharmacy would be able to comply with the Thai law.
Nevertheless, some of its provisions that affect the practice of online pharmacy are the following:
• Prescription and Pharmacy-only drugs are required by law to be sold in a physical
pharmacy and dispensed by a Thai-pharmacist only. (Section 14 – Licensed to sell Rx; and
21 – selling of Rx)
Hence, it is not legally possible to market prescription products online, by mail, and/or by
mail order.
• No person shall produce or sell a modern drug or import or order a modern drug in to the
Kingdom unless he has obtained a license from the licensing authority. (Sec. 12). Persons
who violated this section will lead to imprisonment for a term not exceeding 5 years and
a fine not exceeding the thousand Baht (Sec. 101)
• The following statements below are the exemption from the Sec. 12: (Sec. 13)
a) The production of drugs by Ministries, public bodies and departments which have
a duty to prevent or treat disease, and by the Thai Red Cross and pharmaceutical
organization,
b) The production of drugs in accordance with the prescription of a practitioners in
the vacationers medicine or practitioners in the art of healing for a particular
patient or in accordance with the prescription of a veterinary for a particular
animal,
c) The sale of herbal drugs which are not dangerous drugs, the sale of common
household drugs, the sale of drugs, the sale of drugs by practitioners in the art of
healing in the field of dentistry to their care of the sale of drugs by veterinaries to
their treatment or prevention of animal disease or the sale of drugs by ministries,
public bodies and departments which have a duty to prevent or treat disease and
by the Thai Red Cross and pharmaceutical organization,
d) The personal bringing into the Kingdom of drugs required for personal use for
thirty drugs,
e) The importation by ministries, public bodies and departments which have a duty
to prevent or treat disease, and by the Thai Red Cross and pharmaceutical
organization.
• Persons licensed to sell modern package drugs must have a first- or second-class
pharmacist with the duty to act as provided in Section 39 or Section 40 on duty for the
duration of business hours. (Sec. 21) Violators of this section will be penalized of an
imprisonment not exceeding 3 months or a fine not exceeding 3 months, or both, plus
fine of 500 Baht/day until the licensee has performed correctly to the law. (Sec. 103)
• The licensee to produce drugs or licensee to import drugs into the Kingdom must submit
an annual report concerning the production or importation of drugs that the formula has
been registered each formula in the form prescribed in Ministerial Regulations within the
31st March of the following year. Any drug that the formula has been registered but not
produced or not imported into the Kingdom for two consecutive years, the drug formula
15
shall be withdrawn. (Sec. 85) Violators e.g., submitting false annual report will lead to
imprisonment not exceeding 3 months or a fine not exceeding 5000 Baht, or both (Sec
123-ter).
Generally speaking, importation only applies to manufacturing companies and importers.

If a company has applied for an import license and a drug product license, but does not actually
import such within 2 consecutive years, the company would have its product license for that
product withdrawn. Personal importation is extremely limited, mostly involving medical
practitioners importing medicine for a particular patient, as opposed to patients directly buying
the imported prescription drugs themselves.
Important websites:
www.moph.go.th/ops/oic/data/20131007141753_1_.pdf Thai Drug Law
16
ETHICAL ISSUES LINKED TO ILLEGAL ONLINE PHARMACIES
Due to convenience and privacy features of the internet, many customers (including
patients especially the disabled, elderly, and patients living in remote areas of the country) can
easily become targets of unethical and illegal online pharmacies. (FDA, 2001) Accordingly, Non-
maleficence (doing no harm) and Beneficence (doing good) are ethical principles that some of
these online pharmacies seem to ignore (Bradley-Popovich, 2000). Breach of these principles
happens when illegal online pharmacy puts the patient at risk by:
• Sending out Non-FDA approved (off-label use), contaminated or counterfeit products

• Sending out wrong product, an incorrect dosage, or possibly no product at all
• Dangerous drug interactions and other serious health consequences (antimicrobial
resistance)
In addition, Illegal online pharmacy poses drug’s potential harm – that is, by issuing
prescription drug for the first time without a physical exam, physician, or registered pharmacist
involved in the process. Without a licensed provider prescribing the drug, potential harm
becomes an issue. Adding to this breach in ethics is the fact that many online pharmacies do not
have access to a registered pharmacist to check medications and to answer patients' questions.
(FDA, 2001)
RECOMMENDATIONS
To wrap this up, the following recommendations below can be considered to further
enhance the laws and regulations governing the practice of online pharmacy:
• Reporting mechanism to track illegal online pharmacies

• Strengthening of State Laws and Regulations regarding pharmacy and medical practice,
importation, and cybercrime
• Proper education of the general public (especially the internet users) to stop patronizing
these illegal online pharmacies
• Only buy products that are:
a) FDA approved
b) From registered/legitimate/accredited/approved Drugstores and Pharmacies
• Partnership with Internet companies to track/block/prevent illegal online pharmacies
from operating (As what US-FDA did)
17
REFERENCES
Adcock, A., et al (n.d.). Thailand. Retrieved 17 May 2018 at

http://www.tilleke.com/sites/default/files/2013_Jan_Distribution_Marketing_Drugs_Thailand.
pdf
Adulyadej, B. (1967). Drug Act, B.E. 2510. Retrieved 17 May 2018 at

http://thailaws.com/law/t_laws/tlaw0071_1.pdf
Aduyadej, B. (1967). B.E. 2510: Drug Act of Thailand. Retrieved 23 May 2018 at
http://thailaws.com/law/t_laws/tlaw0071_1.pdf
American Congress (2008). HR 6353: Ryan Haight Online Pharmacy Consumer Protection Act of
2008. The Senate and House of Representatives. Retrieved 23 May 23, 2018 at
https://www.justice.gov/archive/olp/pdf/hr-6353-enrolled-bill.pdf
FDA (2013). FDA Advisory 2013-063: Public warning against health scams in the internet
Gloor, R.W. (2014). Counterfeit Medicines. Philippine Council for Health Research and
Development. Retrieved 17 May 2018 at
http://www.pchrd.dost.gov.ph/index.php/news/library-health-news/4085-counterfeit-
medicines
JPMA (2017). Information on Japanese Regulatory Affairs. Chapter 2, pp15-52. Retrieved 23

May 2018 at http://www.jpma.or.jp/english/parj/pdf/2017.pdf
Kennedym J.W. & Seymour, R. (n.d.). Online Pharmacies: Breach Ethical Principles. East
Tennessee State University. Retrieved 17 May 2018 at http://ojni.org/6_1/article5.htm
Lina, A.D. (2015). Importation of FDA-DOH Regulated Products for Personal Use. Bureau of
Customs. Retrieved 23 May 2018 at http://customs.gov.ph/wp-
content/uploads/2015/10/Memorandum-Importation-of-FDA-DOH-Regulated-Products-For-
Personal-Use.pdf
Littlejohn C et al. Internet pharmacies and online prescription drug sales: a cross-sectional
study. Drugs Education Prevention & Policy, 2005, 12(1):75–80.
People’s Republic of China (2009). Ministry of Health Order No. 66. Retrieved 17 May 2018 at
http://www.gov.cn/flfg/2009-06/23/content_1347818.htm
Philippine Congress (2015). Republic Act 10918: An Act Modernizing and Regulating the Practice
of Pharmacy in the Philippines. The Senate and House of Representatives. Retrieved 23 May
2018 at http://www.officialgazette.gov.ph/2016/07/21/republic-act-no-10918/
18
Philstar (2002). Illegal drug sales on internet booming. Retrieved 17 May 2018 at
https://beta.philstar.com/headlines/2002/02/28/152174/illegal-drug-sales-internet-
booming#346pgYr2ML7eC4uP.99
PSI (2018). Counterfeit Situation. Retrieved 17 May 2018 at http://www.psi-

inc.org/counterfeitSituation.cfm
State FDA (2005). State FDA No. 480: Interim Provisions on Examination on Examination and
Approval of Internet Drug Transaction Services. Retrieved at
www.sfda.gov.cn/WS01/CL0060/9432.html
Sun.Star Davao (2014). PH ranks 8th in fake medicine cases in Asia. Retrieved 17 May 2018 at
http://www.pressreader.com/philippines/sunstar-davao/20141118/281582353928992
Uy, J.R. (2014). FDA warns against fake meds sold by online pharmacies by. Philippine Daily
Inquirer Retrieved 17 May 2018 at http://technology.inquirer.net/39467/fda-warns-against-
fake-meds-sold-by-online-pharmacies
WHO (2011). Safety and Security on the Internet: Challenges and Advances in Member States.
v4, pp 10-11. ISBN 978 92 4 156439 7. Retrieved 17 May 2018 at
http://www.who.int/goe/publications/goe_security_web.pdf
19

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College of Pharmacy | University of the Philippines Manila | 23 May 2018

Online pharmacy services refer to pharmaceutical services of a duly licensed

According to FDA Philippines, the proliferation of online pharmacies as a means of cyber

Philippines USA Australia Japan China Thailand

Legal (as long as for

• Whether in-store or online, Category A pharmaceutical establishments or outlets shall be

report@fda.gov.ph To report counterfeit drug or adverse reaction

• No controlled substance that is a prescription drug as determined under Federal Food,

Currently, there is no Australian jurisprudence on virtual drug distribution. However,

• Products is required to be entered on the Australian Register of Therapeutic Goods

Nevertheless, Article 56 may be exempted or other required exemptions may be

Generally speaking, importation only applies to manufacturing companies and importers.

• Sending out Non-FDA approved (off-label use), contaminated or counterfeit products

• Reporting mechanism to track illegal online pharmacies

Adcock, A., et al (n.d.). Thailand. Retrieved 17 May 2018 at

Adulyadej, B. (1967). Drug Act, B.E. 2510. Retrieved 17 May 2018 at

JPMA (2017). Information on Japanese Regulatory Affairs. Chapter 2, pp15-52. Retrieved 23

PSI (2018). Counterfeit Situation. Retrieved 17 May 2018 at http://www.psi-

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