Source: http://join.gov.tw/openup/idea/detail/f7b732a6-2652-4130-9f18-a0f3fb03fc3c Thanks MOHW for providing the translation.

1. http://join.gov.tw/openup/idea/detail/f7b732a6-2652-4130-9f18-a0f3fb03fc3c
Proposed: 2015-09-24 Reviewed: 2015-10-05
Countersigned: 2015-10-06 (250 signatures), 2015-10-14 (5548 signatures)
Responded: 2015-10-17 (initial response), 2015-11-02 (clarification of issues),
2015-11-15 (provision of information), 2015-12-14 (press release)
Introduce the Immune Cell Therapy Amendment Bill to the
Legislation by the end of December 2015, and accelerate the
approval of new cancer drugs
Caspar Wang (Proposer), 2015-09-24
It goes without saying that there is a very high population of cancer sufferers in
Taiwan. However, at the moment Taiwan's major hospitals still mainly rely on the
traditional methods of radiotherapy, surgery and chemotherapy to treat patients.
What Taiwan's terminal cancer patients may not know is that some time ago their
neighboring countries such as China and Japan have already made available a
more advanced immune cell clinical treatment choice for terminal cancer patents
(Japan introduced this clinical treatment as early as 2007; China's Grade 3
Hospitals have administered this clinical treatment to more than one thousand
patients).
The only reason that Taiwan's terminal cancer patients do not have access to this
treatment is because Taiwan's law-making process is too old-fashioned. It does
not allow this advanced treatment to be legally performed in Taiwan and is
depriving Taiwanese terminal cancer patients of an alternative treatment option.
In recent years, more and more patients have personally testified that they have
traveled overseas to try this yet-to-be-legalized immune cell therapy. However,
cancer patients are usually lacking in physical strength and have to be
accompanied by family members in their travel, so this has made seeking
treatment overseas an exorbitant necessity.

2. In simple terms, this new method of cancer treatment involves culturing one's
immune cells and re-injecting them into one's body; it seeks to destroy the
cancerous cells via the immune cells of one's body. Its key benefit is that it does
not have major side effects that radiotherapy and chemotherapy have on the
body and allows the terminal cancer patient to enjoy a better quality of life.
To terminal cancer patients who cannot undergo traditional treatments, immuno-
therapy is indeed a lifeline and a new source of hope. However, such a law
requires a five to eight year trial in Taiwan, and let's not forget the low efficiency
in getting a new bill pass the legislature in the first place! This is heart-wrenching
for many terminal cancer patients, who simply do not have time to wait!
An even more unfair aspect for Taiwan's terminal cancer patients is that our
process of introducing new drugs lapses significantly behind that of the United
States. Based on the present condition, if a US FDA-approved drug is to be
introduced into Taiwan, it must go through a lengthy clinical trial process before
it can be officially listed in Taiwan. The process itself takes at least two years. This
means that the earliest time a Taiwanese cancer patient can access a currently
new drug would be three years after the patient's need for the medication has
first arisen. It is a classic case of being able to see something but not being able to
reach it.
If the terminal cancer patient cannot wait longer than three years, they would
have to get their physician assessment and apply for an amnesty from the
Ministry of Health and Welfare. The Ministry has the power to veto any
introduction, and the exchange of documents to import the medication would
take at least another month. I ask everyone to think about this: if the terminal
cancer patient has so much time to wait, would they still be called a terminal
cancer patient?
For this reason, I make two proposals in my submission:
1. That the Immune Cell Therapy Amendment Bill be introduced to the
Legislative before the end of December 2015
2. That the passage of new cancer drugs be expedited

3. The two above proposals aim to give more treatment options to terminal cancer
patients who are struggling with their life-threatening conditions. I urge everyone
to countersign the proposal as soon as possible. I appeal to everyone for their
help so that terminal cancer patients in Taiwan can enjoy the rights and
convenience of treatment!
Benefits and Effects
The very simple benefit and effect of this proposal is to give cancer patients
greater chances of survival!
Initial Response
Ministry of Health and Welfare, 2015-10-17
We are grateful to Casper Wang and all Internet users who are interested in this
issue. The Ministry has received the countersigned submissions. The following is a
preliminary explanation about the Ministry’s plan of response to the submission:
1. Current Process for Handling the Case
The day on which this case was established (October 14) happens to coincide with
the "Cell Therapy Management Experts' Forum" convened by the Ministry. Since the
content of this submission is highly relevant to the issue of cell therapy
management, we were able to seek the preliminary views of the experts who were
at the meeting and reach the following consensus:
"For the sake of patients who have urgent medical needs, an open attitude should be
adopted to examine support mechanisms for managing quality and safety. A
ministerial expert committee should be set up as soon as possible to plan a parallel
method to facilitate the technology and products of cell therapy, so that cell therapy
can be made more diverse and flexible.”

4. 2. Subsequent Process
Pursuant to Article VIII of the National Development Council's "Key Points in the
Implementation of On-line Public Policy Proposals", the Ministry must formulate a
complete and specific response within two months (December 14, Year 104). Our
initial process plan is as follows:
• Step 1: Clarification of Issues - to be completed before October 31
Contact the proponent to clarify and confirm the content of the proposals.
• Step 2: Provision of Information - to be completed before November 15
List and publish the information related to the key issues.
• Step 3: Research and Discussion - to be completed before December 13
Research, analyze and assess the feasibility of the proposals; we will convene a
consultative meeting if necessary.
• Step 4: Official Response - to be completed before December 14
The Ministry publishes its formal response on the platform.
Before we officially release our final response, we will, depending on the progress of
our deliberations, continue to use this platform to communicate and share
information with everyone.
We once again extend our thanks to the proponent and the countersigning Internet
users. We ask that you wait patiently for our formal response.
Clarification of Issues
Ministry of Health and Welfare, 2015-11-02
On October 20, the Ministry conducted a proposal clarification meeting. We invited
the proponent Caspar Wang to the Ministry to explain and clarify the proposal. The
meeting record has been verified with the proponent and all participants and has
been released to the public in the annexed document.

5. Provision of Information
Ministry of Health and Welfare, 2015-11-15
Before giving an official response, the Ministry has listed the background
information relating to the case and included it in the annexed document. The
Ministry hopes that by publishing this document, all interested members of the
public will have an opportunity to form a better understanding of the current
programs relevant to the issues raised in the countersigned submission.
Official Response (Part 1/2) — On Introducing the Immune Cell
Therapy Amendment Bill to the Legislation before the end of
December 2015
Ministry of Health and Welfare, 2015-12-14
I. The Circumstances of Immune Cell Therapy in the World
Before giving an official response, the Ministry has listed the background
information relating to the case and included it in the annexed document. The
Ministry hopes that by publishing this document, all interested members of the
public will have an opportunity to form a better understanding of the current
programs relevant to the issues raised in the countersigned submission.
(a) United States
In the United States, cancer immunotherapy is managed by the US Food and Drug
Administration (US FDA). The applicant must submit a clinical trial application to the
Investigational New Drug (IND) or Biological Drug marketing authorization Biologics
License Application (BLA), which must grant approval before the treatment can start.
Currently, US FDA has only one approved immune cell therapy product, Provenge®,
for treating prostate cancer; Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-
T) and other immune cells which are still being researched and developed are
undergoing human trials at the moment.
(b) European Union

6. In the European Union, cancer immunotherapy for treating cancer is managed by
the European Medicines Agency, (EMA). Its regulatory approach is similar US FDA's.
Currently, there is no approved cell-based product on the market.
(c) South Korea
In South Korea, cancer immunotherapy is managed by the Ministry of Food and Drug
Safety (MFDS). Its regulatory approach is similar to those of US FDA and EMA.
Currently, there are two approved immune cell therapy products: Creavax-RCC® and
ImmunCell-LC®. They are used in the treatment of metastatic kidney cancer and liver
cancer respectively.
(d) Japan
In Japan, cancer immunotherapy is an autonomous service (i.e. the user pays for his
or her own treatment). After the Ministry of Health, Labour and Welfare (MHLW)
officially implemented the "Act on Securing of safety of Regenerative Medicine " in
2014, governing laws about management of the service has become stricter. The
applicant must provide a plan of treatment to be reviewed and approved by the
"Certified Special Committee for Regenerative Medicine". In addition, the Cell
Processing Centers (CPC) must pass the inspection by the "Good Cell and Tissue
Practice" (GCTP) to ensure the quality and safety of the cells.
II. The Circumstances of Immune Cell Therapy in Taiwan
Currently, immune cell therapy for treating cancer is still at an experimental stage in
Taiwan. To date, only seven clinical trials have taken place. A testing plan has been
reviewed and approved and applicants are invited to self-register at the "Clinical Trial
Network in Taiwan" website. People should visit this website if they wish to know
more about the clinical trial sites, the contact details, number of test subjects, the
major inclusion / exclusion criteria and other information.
III. A Comparison of Domestic and International Circumstances

7. In most countries, the management of immune cell therapy requires preliminary
human trials. Based on the results and well controlled processes, a cell therapy
product is then given approval and listed on the market. By following the approved
methods of culturing cells, product manufactures or cell biotechnology companies
can manufacture cell-based therapeutic products for treating cancer patients.
Currently, immune cell products are commercially available in the US and South
Korea. Although cell therapy products are not currently available in Taiwan, seven
clinical trials of immunotherapy have already been proposed. In Japan, immune cell
therapy is processed as a special legal category. The physician can propose a plan of
treatment and use a specifically approved cell therapy product to treat a patient,
while charging the required expenses to the patient. This framework is managed
under the "Regenerative Medicine Promotion Act" in conjunction with the added
protection of the "Act on Securing of safety of Regenerative Medicine”.
At this stage, Taiwan's management system follows the US and Europe. Once the
human trials have been completed and their safety and efficacy confirmed, Taiwan
may consider Japan's example and refer to its open management method for
treating specific patients in the future.
IV. Action Plans
1. Establishing the Ministry of Health and Welfare's “Regenerative Medicine and
Cell Therapy Development Advisory Council”
Although the Ministry of Health and Welfare already has the "Ministry of Health and
Welfare Medical Committee - Medical Technology Group" and the "Food and Drug
Administration Regenerative Medicine Advisory Committee" to assist in case-reviews
of cell therapy human trials, in the wake of the ever-changing state of cell therapy
technology and international regulatory review methods, and in response to the
countersigners’ concerns about cell therapy, the Ministry has established the
"Ministry of Health and Welfare's Regenerative Medicine and Cell Therapy
Development Advisory Council" on November 23, 2015. The Council is responsible
for giving policy advice about regenerative medicine and cell therapy development

8. and ensuring the safety of patients who are receiving treatment. "Immune cells
cancer therapy" is listed as a priority discussion topic.
2. Planned Liberalization of Treatment Programs for Seriously Ill Patients
To offer the patients suffering from serious or life-threatening diseases more
treatment options, the Ministry is examining the formulation of a clinical trials
"treatment protocol" for approved doctors to assist patients who are facing "life-
threats or serious disability" and who have "no appropriate domestic medication or
alternative therapy". These patients can apply for a special or group patient
treatment and pay the necessary costs that medical institutions are entitled to
charge patients under consent. A report about the "treatment protocol" and
affiliated program is expected to complete in January-February, 2016.
In summary, the Ministry is committed to ensuring patients' rights and safe
treatment, and providing alternative options for patients who do not meet the
criteria of existing human trial programs.
V. Adoption of the Original Proposal
In response to the proponent's submission that the Immune Cell Therapy
Amendment Bill should be introduced to the Legislation before 31 December 2015,
the Ministry of Health and Welfare argues that while no new law specific to immune
cell cancer therapy is currently being developed, the Ministry has already begun to
examine ways to amend the human testing treatment protocol adjunct to the
"Regulations on Human Trials", so that severely ill patients can have alternative
treatment options in addition to ordinary treatments. Moreover, this process can
increase the willingness of domestic physicians to perform cell immunotherapy and
benefit more cancer patients.
VI. Follow-up Plans
1. Short Term

9. (e) The Ministry of Health and Welfare is looking at revising the "Regulations on
Human Trials", prescribing the relevant terms and conditioetns of the affiliated
human trial treatment protocol, and expanding the practical availability of
immune cell therapy for treating seriously ill patients.
(f) The Ministry of Health and Welfare has convened a "Regenerative Medicine and
Cell Therapy Development Advisory Council" meeting to examine and formulate
a management structure that is compatible with international standards and
suitable for domestic needs.
2. Medium to Long Term
(a) It is proposed that, after the human trials of immune cell therapy have been
completed, immune cell treatment should, based on its safety and efficacy, be
listed as a conventional medical treatment or regulated as a specific cell product.
Supported by relevant measures, domestic physicians should be able to perform
immune cells therapy for cancer treatment.
(b) By reviewing the outcomes of the follow-up actions and consulting Japan’s
regulatory model, the Ministry of Health and Welfare will promote a reform bill
and develop product regulations to ensure the quality and variety of treatment
methods for the benefit of our citizens.
Official Response (Part 2/2) — On Accelerating the Introduction
of New Cancer Drugs
Ministry of Health and Welfare, 2015-12-14
I. Analysis of Circumstances
1. The submission has pointed out that new drugs are commercially available in
Taiwan much later than in the United States. The main reason for this is because
of the structure and considerations of the international pharmaceutical market,
and its tendency to apply to list new drugs for sale in Taiwan later than in the

10. United States and Europe. An analysis of the processing time for reviewing new
cancer drugs in Taiwan and the United States indicates that the time frame is
around 200 to 240 days.
2. Does Taiwan require imported new drugs approved in the US to undergo
mandatory domestic clinical trials? Only a small number of drugs assessed to be
subject to racial difference are required to undergo further domestic targeted
subject studies. The majority of drugs assessed not to be subject to racial
difference do not require domestic clinical trials.
3. If a patient has been assessed by a doctor to require the use of an overseas
medication not yet listed in Taiwan, he or she must lodge a special application in
accordance with the "Drug Sample and Complimentary items Management Act".
If the drug falls within the range of approved treatment for an illness in the
drug's country of origin, the application will be approved. The processing time is
about 1 to 3 days. For example: the new medicine Kysuda® or Opdivo® is
importable through special application for cancer treatment (30 cases of
application per month). If the cancer being treated falls outside the original
approved range, another medical expert will be asked to assess the safety and
reasonableness of the application. The processing time is about 3 to 5 days.
II. Action Plans
1. By way of encouraging international pharmaceutical companies to apply for new
drug listings earlier in Taiwan, the Food and Drug Administration (TFDA) in 2012
announced the deregulation of the administrative document CPP (Certification
of Pharmaceutical Products), and encouraged international pharmaceutical
companies to include Taiwan in their human trial subject research and
development. A successful example is the "new generation of cancer-targeting
drug (Afatinib®)". Taiwan led the US and EU as the world's first country to
approve the listing of this medicine, which has provided lung cancer patients
with a new treatment option.
2. Furthermore, in order to accelerate the review of new drugs for unmet medical
needs, TFDA has progressively announced the implementation of the

11. "Regulations for Registration of Medicinal Products Abbreviated Review
Mechanism" (approved by the United States and Europe for Taiwan to receive
fast review of new drug listings), the "Regulations for Registration of Medicinal
Products Priority Review Mechanism" and the "Regulations for Registration of
Medicinal Products Accelerated Approval Mechanism" (new drugs for treating
serious or life-threatening conditions are given priority review). An analysis has
revealed that in Taiwan anti-cancer drugs generally have shorter review time
than other new drugs.
3. In recent years, cancer immunotherapy has achieved a breakthrough
development. Apart from immune cell therapy, there is also monoclonal
antibody drugs and other treatments. Presently, the latest, most clinically
significant cancer immunotherapy is the use of monoclonal antibodies to block
the immunosuppressive molecules. In 2014, US FDA approved three such game-
changing anti-cancer drugs (Yervoy®, Kytuda®, Opdivo®).In 2015, Taiwan has also
approved two new drugs (Yervoy®, Kytuda®).
III. Adoption of the Original Proposal
As the action plan above indicates, TFDA already has several accelerated
introduction programs in place. In the future, it will endeavor to promote the above
programs, so that more international pharmaceutical companies will lodge their new
drug applications in Taiwan early to the benefit of our patients. Information about
domestically licensed drugs can be obtained from the "Medicinal Products, Medical
Devices and Medicated-cosmetics Licenses Inquiry” website.
IV. Follow-up Plans
In the future, we will continue to accelerate cancer drug reviews, construct complete
human testing environments, and encourage international pharmaceutical
companies to come to Taiwan to perform trials, so that our patients can have access
to more innovative and plentiful choices in their cancer treatment.