Legal & Regulatory > Singapore > Orphan Drugs & Rare Diseases

The ins and outs of orphan drugs & rare diseases in Singaporean Pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.

1. What is the definition of Rare Diseases in your country?

As at the date hereof, there is no legal definition of rare diseases in Singapore.

In a press release dated 2 July 2019, the Ministry of Health of Singapore (“MOH”) defined a rare disease as a condition that affects fewer than 1 in 2,000 people.

2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)

As at the date hereof, there is no publicly available designation of “orphan drug” in Singapore.

3. What is the regulatory framework for the authorisation of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)

Prior to 1 November 2016, orphan drugs were regulated under the Medicines Act (Chapter 176) of Singapore. Specifically, the regulations relating to orphan drugs were contained in the Medicines (Orphan Drugs) (Exemption) Order (“Orphan Drugs Order”).

However, as part of the Health Sciences Authority of Singapore’s (“HSA”) efforts to consolidate the existing regulatory controls under a single legislation, namely, the Health Products Act (CHP of Singapore) (“HPA”), the Orphan Drugs Order was repealed.

The HPA does not contain any specific reference in relation to orphan drugs or rare diseases. However, the HPA would govern orphan drugs in the same manner in which other therapeutic products are governed under the HPA.

4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?

As at the date hereof, there are no publicly available provisions for relaxed clinical trial / scientific evidence requirements in respect of orphan drugs as compared to other drugs in Singapore.

5. Is there an expedited pathway for Orphan Drugs?

As at the date hereof, there is no publicly available information relating to expedited pathways for orphan drugs, if any.

However, in general, there are four types of evaluation routes for registering a new therapeutic product, namely (i) the full route, (ii) the abridged route, (iii) the verification route and (iv) the verification-CECA route. The full route has the longest turnaround time, followed by the abridged route and the verification route.

The full route applies to any new product that has not been approved by any drug regulatory agency. The abridged route applies to any new or generic product that has been evaluated by at least one drug regulatory agency. The verification route applies to a new or generic product that has been evaluated and approved by one of the HSA’s reference drug regulation agencies. The verification-CECA route applies to any new or generic product manufactured in India that has been evaluated and approved by one of the HSA’s reference drug regulation agencies.

HSA’s reference drug regulatory agencies include Australia’s Therapeutics Goods Administration, the European Medicines Agency, Health Canada, the UK Medicines and Healthcare Products Regulatory Agency and the USA Food and Drug Administration.

The Therapeutic Products Guidance provides that where a product has been designated as an Orphan Drug by at least one reference drug regulatory agency, or has been approved by at least one reference drug regulatory agency via an accelerated approval, approval under exceptional circumstances or equivalent approval process, the applicant should consult the HSA on the eligibility for the verification route. It thus appears that the HSA would determine whether the shorter verification route can be taken to register the Orphan Drug.

6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?

There are no specific foreign marketing organisations recognized in Singapore for orphan drugs.

7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan drugs?

No specific procedures. The market price of a medicinal product is not generally governed by law or regulation in Singapore. However, the MOH administers several drug subsidy schemes (the Standard Drug List (SDL), Medication Assistance Fund, inpatient drug subsidy, etc).

8. How are the prices of Orphan Drugs regulated?

As at the date hereof, there is no publicly available information on the regulation of Orphan Drug prices.

The MOH and SingHealth Fund have jointly established the Rare Disease Fund (“RDF”) in 2019. The RDF is a charity fund that combines community donations and government matching contribution to support Singapore citizens with specific rare diseases. This initiative aims to support patients whose treatment costs remain unaffordable even after government subsidies, insurance and financial assistance.

9. In case of reference price based on a basket of countries, what countries are included?

As at the date hereof, there is no such publicly available information.

10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?

As at the date hereof, there is no such publicly available information.

11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?

As at the date hereof, there is no such publicly available information.